If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception
Pregnant or lactating woman (any woman of childbearing potential who has menstruated within the year prior to enrolment will undergo pregnancy testing within 72 hours prior to receiving the first dose of study medication)
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to initiating study treatment
Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to study registration; Note: If study treatment is not initiated within 7 days after the pregnancy test, the pregnancy test must be repeated
If a woman is of childbearing potential, a negative serum pregnancy test must be documented
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within 1 week before first dose (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women ?55 years] or 12 consecutive months [women >55 years])
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization
For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within 1 week before randomization (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women ? 55 years] or 12 consecutive months [women > 55 years])
Negative pregnancy test (if woman of childbearing potential)
Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 72 hours prior to enrollment \Woman of childbearing potential\ is defined as any woman who has not undergone a hysterectomy and who has had menses at any time in the preceding 24 consecutive months
If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
Woman
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to re-registration is required
Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Negative pregnancy test performed =< 7 days prior to registration (women of childbearing potential only)
Women of childbearing potential must have a negative serum pregnancy test less than or equal to 7 days prior to registration.
Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential must have a negative pregnancy test within 14 days of registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done ? 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test for persons of childbearing potential =< 7 days prior to registration
Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
For women of childbearing age, negative pregnancy test within 14 days prior to registration
Pregnancy restrictions - Women of childbearing potential must have a negative B-HCG documented within 7 days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test for women of childbearing potential within 14 days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
A negative pregnancy test within 7 days prior to registration for women of childbearing potential; in addition, male and female participants must commit to adequate contraception while on study
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test performed =< 7 days prior to registration for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done ? 7 days prior to registration, for persons of childbearing potential only
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Women of childbearing potential must have a negative serum pregnancy test as a part of eligibility, within 28 days of registration.
Negative pregnancy test done at screening and ? 3 days (72 hours) prior to registration, for women of childbearing potential
Negative pregnancy test performed =< 7 days prior to registration (women of childbearing potential only)
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
Women of childbearing potential must have a negative pregnancy test within 30 days of registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
For women of childbearing potential, a negative serum pregnancy test within 14 days of registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential
ARM A: Negative serum pregnancy test =< 7 days prior to registration for women of childbearing potential only
ARM B: Negative serum pregnancy test =< 7 days prior to registration for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
For women of childbearing potential only: negative urine or serum pregnancy test done =< 7 days prior to registration
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration or randomization
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Women of childbearing potential only: negative serum pregnancy test done =< 14 days prior to registration
Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential
For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration
For women of childbearing potential, a negative serum pregnancy test within 2 weeks of registration
Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Negative serum pregnancy test within three days prior to registration for women of childbearing potential
Women of childbearing potential must have a negative pregnancy test prior to registration.
Pregnancy or lactating females; women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration
Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration for protocol therapy.
Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration
Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential must have a negative serum pregnancy test =< 7 days prior to registration
Women of childbearing potential must have a negative pregnancy test within 14 days of registration
Negative pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential only: negative pregnancy test done =< 7 days prior to registration
Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 2 weeks prior to registration.
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Negative urine or serum pregnancy test =< 14 days prior to registration for women of childbearing potential
Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test pregnancy test done =< 7 days prior to pre-registration is required
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Negative serum pregnancy test =< 7 days prior to pre-registration for women of childbearing potential
Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test for female subjects with reproductive potential =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Not pregnant and not nursing\r\n* For women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
Negative serum pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
Women of childbearing age must have a negative serum pregnancy test within 14 days prior to registration
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Negative pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
Not pregnant; for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done ? 7 days prior to registration, for women of childbearing potential
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
The following women are WOCBP:\r\n* Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides)\r\n* Women who are practicing abstinence\r\n* Women who have a partner who is sterile (e.g., due to vasectomy)
WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; in general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL\r\n* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential\r\n* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab\r\n* Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause or\r\n* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy during the study and for at least 4 months after the last dose of study drugs in such a manner that the risk of pregnancy is minimized. Men on study also must be using contraception. Women of childbearing potential (WOCBP) are women who have not been postmenopausal greater than 1 year or undergone a hysterectomy or bilateral oophorectomy.
Women of childbearing potential (WOCBP) and male patients with WOCBP as partners must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of the investigational agent; subject is practicing an acceptable method of contraception (documented in case report form [CRF]); WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause or
Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods\r\n(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Pregnant or breast-feeding women; women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry; both sexes must use contraception while on study; WOCBP include:\r\n* Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic >= 12 consecutive months)\r\n* Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mlU/ml\r\n* Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence of where the partner is sterile
Women must not be pregnant or breastfeeding; all women of childbearing potential must have a blood test within 72 hours to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study, and for women at least 23 weeks after the last dose of investigational product and for men at least 31 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
Women must not be pregnant or breast-feeding due to unknown effects of treatments on the unborn fetus. All women of childbearing potential must have a blood test within 72 hours prior to randomization to rule out pregnancy. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. Sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential. Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g.,vasectomy) should be considered to be of childbearing potential.
Men and women of childbearing potential (WOCBP) must be using 2 reliable methods of contraception to avoid pregnancy throughout the study for a period of at least 30 days before and 90 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; men on study and for at least 6 months after the last dose of nab-paclitaxel also must be using contraception; women of childbearing potential (WOCBP) are women who have not been postmenopausal greater than 1 year or undergone a hysterectomy and/or bilateral oophorectomy
Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause or\r\n* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL\r\n* Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab; men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as: amenorrhea >= 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential
Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last dose of investigational product] in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion and/or at least 3 months after the study agents LV305 or CMB305 are stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for at least 8 weeks after pembrolizumab is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; acceptable forms of birth control include condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is also an acceptable form of birth control
Even women who are using oral, implanted, transdermal, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, practicing abstinence, or whose partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI, in such a manner that the risk of pregnancy is minimized; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential \r\n* Men of fathering potential and WOCBP must be using an adequate method of contraception to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible\r\n* WOCBP are not eligible if they satisfy any of the following:\r\n** A positive pregnancy test at baseline\r\n** Pregnant or breastfeeding
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Women must not be pregnant or breastfeeding; all women of childbearing potential must have a blood test within 72 hours to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy; NOTE: a woman of childbearing potential (WOCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); for the purposes of this study, post-menopause is defined as: \r\n* Amenorrhea >= 24 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL\r\nWomen who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; men of fathering potential and WOCBP must be using an adequate method of contraception or must abstain from sexual intercourse to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 3 months after the last dose of ipilimumab in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product; men on study also must be using contraception
Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after completion of the study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
Women of childbearing potential (WOCBP) and male subjects of fathering potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized\r\n* WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n** Amenorrhea >= 12 consecutive months without another cause, or\r\n** For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL\r\n* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\r\n* Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 3 months after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk of pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
COHORT A: Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of ipilimumab) in such a manner that the risk of pregnancy is minimized
COHORT B: Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of ipilimumab) in such a manner that the risk of pregnancy is minimized
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine test during screening to rule out pregnancy\r\n* NOTE: a woman of childbearing potential (WOCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\r\n* Post-menopause is defined as:\r\n** Amenorrhea >= 12 consecutive months without another cause, or\r\n** For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL\r\n* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\r\n* Men of fathering potential and WOCBP must be using an adequate method of contraception to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible\r\n* WOCBP are not eligible if they satisfy any of the following:\r\n** A positive pregnancy test at baseline\r\n** Pregnant or breastfeeding
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as: amenorrhea >= 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential
Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post-menopausal is defined as:\r\n * Amenorrhea >= 12 consecutive months without another cause, or\r\n * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 1 week prior to the start of investigational product
Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 30 days after the last dose of study drug to minimize the risk of pregnancy; WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea that has lasted for >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL\r\nWomen who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of the investigational product; a male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study (and for up to 30 days after the last dose of study drug) to minimize the risk of pregnancy; a barrier method is recommended
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of chemotherapy in such a manner that the risk of pregnancy is minimized\r\n* WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or whose partner is sterile (vasectomy) should be considered to be of childbearing potential\r\n* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the first dose of investigational product
Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; women who use oral, implanted or injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 5 months after the last dose of investigational product; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea > 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL\r\n* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, have had tubal ligation or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential\r\n* WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 48 hours before the start of nivolumab and ipilimumab\r\n* Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 7 months after the last dose of investigational product)
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment; WOCBP is defined as follows: any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months, or women on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone (FSH) level > 35 mIU/ml); even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g. vasectomy), should be considered to be WOCBP; prior to study enrollment, WOBCP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in additional, men enrolled on this study should understand the risks to any sexual partner of childbearing potential; all WOCBP must have a negative pregnancy test within 72 hours prior to receiving the first dose of the investigational agent(s); if the pregnancy test is positive, the patient must not receive protocol treatment and must not be enrolled in the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately; if a WOCBP becomes amenorrheic during treatment, a pregnancy test must be performed
Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks prior to initiation of dosing, and for at least 60 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL\r\nWomen who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential\r\nWOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours\r\nMen of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Pregnant or breast-feeding women; women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry; male and female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after last dose of study drug; WOCBP include:\r\n* Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic >= 12 consecutive months)\r\n* Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml\r\n* Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence of where the partner is sterile
Pregnant women are excluded from this study; women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately; prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential; all WOCBP must have a negative pregnancy test within 72 hours prior to receiving the first dose of the investigational agent(s); registration may occur prior to this pregnancy test; if the pregnancy test is positive, the patient must not receive protocol treatment and must not be enrolled in the study; WOCBP is defined as follows: any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months, or women on hormone replacement therapy [HRT] with documented plasma follicle-stimulating hormone [FSH] level > 35 mIU/ml); even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g. vasectomy), should be considered to be a WOCBP
Women of childbearing potential (WOCBP) must be willing to use an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized
Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry
Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
Negative serum pregnancy test if women of childbearing potential (WOCBP) (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized)
Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry
Negative serum pregnancy test for women of childbearing potential
Pregnant or lactating women; a negative pregnancy test in women of childbearing potential must be documented within 7 days before the first dose of study medication
Negative pregnancy test for women of childbearing potential (< 51 years of age) as per institutional policy
Negative serum pregnancy test in women of childbearing potential (WOCBP)
Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to study registration; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
A negative pregnancy test =< 7 days prior to treatment for premenopausal women and for women < 1 year after the onset of menopause
Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than (<) 12 months after menopause
Women of childbearing potential must have a negative pregnancy test
Negative serum pregnancy test for women of childbearing potential
Negative serum pregnancy test in women of childbearing potential
Women of childbearing potential must have a negative pregnancy test
Positive pregnancy test; Note: Pregnant women are excluded from this study; breastfeeding should be discontinued; negative serum pregnancy test will be required for women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy
Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women <= 2 years after menopause
Women of childbearing potential must have a negative pregnancy test.
Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study
Negative pregnancy test (within 7 days of enrollment) in women of childbearing potential
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year
Negative serum pregnancy test within 7 days of commencement of treatment in women of childbearing potential
Negative pregnancy test (women of childbearing potential)
Female participants who are pregnant or breastfeeding; women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization; all women of childbearing potential must be willing to comply with an acceptable birth control regimen to prevent pregnancy while receiving treatment and for 3 months after treatment is discontinued as determined by the Investigator; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; (note: a woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives)
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Non pregnant and non-nursing women; women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
Negative serum pregnancy test within 2 weeks of lymphodepletion chemotherapy for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
Women of childbearing potential must have negative pregnancy test prior to initiating study treatment.
Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration; women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, are naturally postmenopausal for at least 12 consecutive months or have undergone surgical removal of the ovaries
Negative serum pregnancy test within 7 days prior to cycle 1/day 1 for women of childbearing potential
Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
Negative serum pregnancy test at screening for women of childbearing potential
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; women of childbearing potential are defined as those who have not been surgically sterilized and have had a menstrual period in the past year
Negative serum pregnancy test at screening for women of childbearing potential
Negative serum pregnancy test at screening for women of childbearing potential
Negative serum pregnancy test within =< 7 days prior to the first dose of study drug, for women of childbearing potential only
Women who are pregnant or breast-feeding, or intend to become pregnant during the study; women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Pregnant or breast-feeding patients; women of childbearing potential (WOCBP) must have a serum pregnancy test performed a maximum of 7 days before the start of study treatment, and a negative result must be documented before the start of study treatment
Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration; women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries; all others are considered women of child bearing potential
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment
A negative pregnancy test (only for women of childbearing potential [WOCBP])
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Women of childbearing age must have a negative serum pregnancy test to meet eligibility per Duke policy
Women of childbearing potential must have a negative pregnancy test; women of childbearing potential are defined as all women except women who are postmenopausal or who have had a hysterectomy; postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least one year; breastfeeding should be discontinued if the mother is treated with E7 TCR transduced peripheral blood lymphocyte (PBL); these potential risks may also apply to other agents used in this study
A negative serum pregnancy test at screening for women of childbearing potential (WOCBP)
Women of childbearing potential must have a negative qualitative serum pregnancy test =< 2 weeks prior to study entry
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >=1 year
Women who are pregnant or lactating. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment.
Pregnant and breastfeeding women will be excluded; women of childbearing potential must have a negative pregnancy test within 14 days of initiation of treatment
Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
INCLUSION CRITERIA FOR TNBC: Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
A negative serum or urine pregnancy test must be done within 72 hours before the first dose of the study medication for women of childbearing potential as per institutional guidelines; post-menopausal women (defines as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy test
Negative pregnancy test within 7 days prior to commencement of dosing in premenopausal women, women of non childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Pregnant or breast-feeding patients; women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment
Women of childbearing potential must have a negative blood pregnancy test at the screening visit
Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Negative serum pregnancy test (women of childbearing potential only)
Negative serum pregnancy test for women of childbearing potential
Negative serum pregnancy test for women of childbearing potential
Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment.
Negative pregnancy test in women of childbearing age
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
For women of childbearing age, a negative pregnancy test performed within 14 days of surgery
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to study entry
Women of childbearing potential must have a pregnancy test at screening
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Negative serum pregnancy test in women of childbearing potential
Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy
Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within 3 days prior to study initiation.
Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment
Childbearing age women with negative pregnancy test
Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of sorafenib in this long term extension program.
Pregnant women or women of childbearing potential and not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential; no breast-feeding while on study.
Women of childbearing potential who have negative pregnancy test results
Negative pregnancy test in women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgement of the investigator
Pregnant or lactating women; pregnant women are excluded from this study; women of childbearing potential must have a negative pregnancy test per standard of care prior to the surgery for tumor removal; a second pregnancy test must be performed 7 days prior to the first vaccination and must be negative; breastfeeding should be discontinued if the mother is treated on study
Negative serum pregnancy test done =< 14 days prior to randomization, for women of childbearing potential only
Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 28 days prior to initiation of study drug
Negative serum pregnancy test within 7 days of treatment initiation with ibrutinib in women of childbearing potential (WOCBP)
Pregnant women are excluded from this study; women of childbearing potential must have a negative pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to start of study treatment
Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study treatment
Women of childbearing potential (defined as having a menstrual cycle within the past 12 months and not having had a surgical procedure to accomplish sterilization) must have a negative serum pregnancy test within seven days of screening
Women of childbearing potential (defined as having a menstrual cycle within the past 12 months and not having had a surgical procedure to accomplish sterilization) must have a negative serum pregnancy test within seven days of starting the vemurafenib
-Pregnant or lactating women.  Women of childbearing potential must have a negative\n             pregnancy test.  Pregnancy testing is not required for post-menopausal or surgically\n             sterilized women.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to enrollment; women of childbearing potential and men must agree to use adequate contraception prior to enrollment and for the duration of study participation
Negative blood pregnancy test at Screening for women of childbearing potential
Negative serum pregnancy test in women of childbearing potential within 2 weeks of study
Premenopausal women must have a negative serum pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months.
Women of childbearing potential must have a negative pregnancy test
Negative blood pregnancy test at the screening visit for women of childbearing potential
Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Women of reproductive potential must have a negative serum pregnancy test obtained within 3 days before the start of anetumab ravtansine
Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
Women of childbearing age with a negative pregnancy test documented prior to enrollment
Women of childbearing age with a negative pregnancy serum test documented prior to enrollment
Negative pregnancy test for women of childbearing potential (< 51 years of age) as per institutional policy
Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
Women of childbearing potential must have a negative serum pregnancy test performed within 2 weeks prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Negative serum pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only; note: post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women who are pregnant or breast-feeding; women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative pregnancy test
Negative pregnancy test (women of childbearing potential)
Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of study drug administration
Negative pregnancy test within 7 days prior to starting the study premenopausal women; women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within 2 weeks prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Negative pregnancy test (women of childbearing potential only)
Negative pregnancy test for women of childbearing potential
Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days prior to day 1 (D1) of treatment
Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ? 72 hours prior to Day 1 of study.
Women of childbearing potential must have a negative pregnancy test within 30 days prior to study registration. Women should be counseled regarding acceptable birth control methods to utilize from the time of screening to start of treatment. If prior to treatment after discussion with the subject it is felt by the treating physician there is a possibility the subject is pregnant a pregnancy test should be repeated. Women of childbearing potential must have a negative pregnancy test within 30 days prior to study registration.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
A positive serum pregnancy test within 14 days prior to treatment in women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
Women of childbearing potential must have a negative pregnancy test within 7 days prior to study treatment
Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication
Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test at screening; women of child bearing potential must undergo pregnancy testing prior to each dose if the previous pregnancy test was greater than 14 days prior and a pregnancy test at 6 months after the last dose
Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment
Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test at screening
Pregnancy or breast feeding - women of childbearing potential must have a negative pregnancy test within 28 days of study enrollment
Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment.
Women of childbearing potential with negative serum pregnancy test prior to randomisation
Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test at screening
Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
Women of childbearing potential must have a negative, qualitative serum pregnancy test =< 2 weeks prior to study entry
Negative serum pregnancy test in women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of pazopanib treatment and both men and women must be willing to use adequate contraception
Pregnant or breastfeeding patients; women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of FOLFIRI treatment, and a negative result must be documented before start of treatment
Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 120 days after last pembrolizumab administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ? 72 hours prior to Day 1 of study.
of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following:
Negative serum pregnancy test in women of childbearing potential;
Negative pregnancy test for women of childbearing potential
Women of childbearing potential must have a negative pregnancy test performed within 2 weeks prior to the start of treatment
Women of childbearing age must have a negative serum pregnancy test, and adequate contraception method(s) must be documented
Women of childbearing potential have a negative pregnancy test
Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
For women of childbearing potential, negative serum pregnancy test;
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days prior to day 1 (D1) of treatment
Pregnant or breastfeeding; a negative blood-pregnancy test is required for women of childbearing potential (WOCBP) within 14 days prior to her computed tomography (CT) stimulation for treatment planning
Women of childbearing potential must have a negative serum pregnancy
Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
Negative serum or urine pregnancy test within 7 days prior to study treatment in premenopausal women and women </= 2 years after menopause (menopause is defined as amenorrhea for >/= 2 years)
For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Positive pregnancy test in women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a pregnancy test at screening
Negative pregnancy test for women of childbearing potential within 7 days of starting study treatment
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Negative pregnancy test for women of childbearing potential
For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
Adequate bone marrow function Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within 14 days prior to study initiation.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Pregnant or lactating women are not eligible; women of childbearing potential must have a negative serum or urine pregnancy test completed within 7 days of study treatment; women or men of childbearing potential not using a reliable and appropriate contraceptive method are not eligible; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test at screening
Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; women of childbearing potential must have a negative serum pregnancy test within 24hrs prior to receiving the first dose of study medication
Pregnant or lactating women; female subjects of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of treatment; (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential must have a serum pregnancy test performed within 28 days prior to the first day of study drug dosing.
Women of childbearing potential (WOCBP) must have a negative pregnancy test performed prior to the start of study drug
Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women less than (< 2) years after the onset of menopause
Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment.
Women of childbearing potential must have a negative serum pregnancy test at the screening visit.
Women of childbearing potential (WOCBP) who have a positive serum pregnancy test within 14 days of the first administration of oral dasatinib
Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after entering menopause
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as age >= 50 years and no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative blood pregnancy test
Women of childbearing potential must have a negative serum pregnancy test before study entry.
Negative serum pregnancy test within 14 days before starting study treatment in women with childbearing potential
Negative pregnancy test for women of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Women of childbearing potential must have a negative pregnancy test to be eligible
Negative pregnancy test for women of childbearing potential
Pregnant or lactating women are not eligible; women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period
Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment
Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the investigator; perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug
Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential
Premenopausal women (including women who have had a tubal ligation and for women less than 12 months after the onset of menopause) must have a negative serum pregnancy test
Women of childbearing potential must have a negative pregnancy test and agree to practice a medically acceptable contraception regimen for the study duration. Women who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test
Non-pregnant; women of childbearing potential must have a negative pregnancy test to participate in this study
Negative pregnancy test for women of childbearing potential
Negative serum pregnancy test (in women of childbearing potential) =< 14 days prior to Step 2; women of childbearing potential and men who are sexually active must practice adequate contraception while on study
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women of childbearing potential : negative pregnancy test
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than or equal to (<=) 12 months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) 12 months.
Negative (serum) pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
Women of childbearing potential (women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, and women who have had a tubal ligation) are required to have a negative urine pregnancy test within 14 days prior to the first dose of lithium
Negative pregnancy test at time of signing consent for women of childbearing potential
Negative pregnancy test for women of childbearing potential
Women of childbearing age with a negative pregnancy test documented prior to enrollment
A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ? 1 year or who have a history of hysterectomy or surgical sterilization)
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test or who are lactating
Patients must not be pregnant or breast feeding; women of childbearing potential are required to obtain a negative pregnancy test within 14 days of starting treatment; effective contraception (men and women) must be used in subjects of childbearing potential
Women of childbearing potential must have a negative pregnancy test
Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within 14 days prior to PET scan
Negative pregnancy test within 7 days prior to starting the study in premenopausal women; women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year
Women of childbearing potential who refuse a pregnancy test
Pregnant or breast feeding women are excluded from this study; women of childbearing potential must have a negative pregnancy test within 3 days prior to receiving indocyanine green
Negative serum pregnancy test in women of childbearing potential
Women of childbearing age must have a negative blood pregnancy test
Women of childbearing potential who refuse a pregnancy test (performed during screening)
Women of childbearing potential will undergo a pregnancy test
Women of childbearing age must have a negative pregnancy test at screening/baseline
Women of childbearing potential must have a negative pregnancy test prior to the administration of protocol specified interventions
Negative serum pregnancy test at screening for women of childbearing potential
Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women <= 2 years after start of menopause
Pregnant or lactating women; all pre-menopausal women being screened must have a negative serum pregnancy test within 14 days prior to commencement of dosing; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year
Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
For women of childbearing potential, negative serum pregnancy test within 7 days of enrollment
Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; a woman of childbearing potential is defined of one who is biologically capable of becoming pregnant; reliable contraception should be used from trial screening and must be continued throughout the study
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; women of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year.
For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum pregnancy test must be documented in the 14 days before the first dose of study treatment For females who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, during the study treatment period and for at least 6 months after the last dose of study treatment For males: agreement to use a barrier method of contraception during the study treatment period and for at least 6 months after the last dose of study treatment
Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation; they must also have a negative urine pregnancy test within 7 days of starting treatment
Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to use effective contraception
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception up until three months after of receiving the last drug treatment
Female subject of childbearing potential (ie, premenopausal or not surgically sterile) must agree to use effective contraception from Day 1 until 28 days after the last dose of study drug, and have a negative serum or urine pregnancy test within 2 weeks prior to Day 1. Sexually active male subjects must also use effective contraception from Day 1 until 90 days after the last dose of any study drug.
Women of childbearing potential must have a negative pregnancy test at screening and must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months after the last dose of IMGN853 and gemcitabine
Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method during the study and for 3 months after last study drug administration
STRATUM A: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for 16 weeks after discontinuation of the study drug
STRATUM B: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for 16 weeks after discontinuation of the study drug
STRATUM C: Female participants of childbearing potential must have a negative pregnancy test at the time of SJDAWN study enrollment and be willing to use a highly effective method of contraception throughout the study and for 8 months after discontinuation of the study drug
Women of child-bearing potential must have a negative serum pregnancy test within 24 hour of initiation of dosing and must agree to use an effective form of contraception during the study from the time of the negative pregnancy test up to 6 months after the last dose of study drug; effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year; fertile men must also agree to use an effective method of birth control while on study drug and up to 6 months after the last dose of study drug
Pregnant and/or breastfeeding; women of childbearing potential must have a negative serum pregnancy test within 28 days of study entry; female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment
Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug. Infusion sub-study prior therapy requirements: Same as above, except:
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to start of study drug. Sexually active subjects must be willing to use two medically accepted methods of contraception, one of them being a barrier method during the study and for 5 months (or 6 months for subjects on Combination Therapy cohort) after last study drug administration.
Pregnancy and contraception:\r\n* Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential\r\n* Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (?7 days prior to 1st study drug dose) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year.
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
Female patient has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential; non-childbearing potential is defined as follows (by other than medical reasons):\r\n* >= 45 years of age and has not had menses for > 1 year\r\n* Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\r\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation; documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound; tubal ligation must be confirmed with medical records of the actual procedure; otherwise the patient must be willing to employ methods to avoid pregnancy; abstinence is an acceptable method to avoid pregnancy if this is the established and preferred method for the patient; alternatively, the patient and partner must use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment; information must be captured appropriately within the site’s source documents\r\n** Male patients must also agree to use an adequate method to avoid pregnancy, which may include abstinence, if this is the established and preferred method for the patient starting with the first dose of study treatment through 180 days after the last dose of study treatment.\r\n** Additionally, the participants must agree to not breastfeed during the study or for 180 days after the last dose of study treatment
Females of child bearing potential must have a negative serum pregnancy test with 7 days prior to first dose of treatment; female patients of childbearing potential and all male partners must agree to use double barrier methods of contraception throughout the study period and for at least 30 days following investigational product discontinuation
Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must agree to both of the following:\r\n* Use highly effective methods of contraception for at least 6 months after the last dose of huJCAR014, and\r\n* Have a negative serum pregnancy test performed within 28 days before starting lymphodepleting chemotherapy
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1 and agree to use effective contraception, throughout the treatment period, and for 4 months after the last dose of study treatment
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (>= 45 years old and without menses for >= 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential
Men must agree to not donate sperm while on the study and for at least 3 months after the last dose of study drug(s); women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to the first administration of isatuximab and at the end of treatment visit; a negative urine pregnancy test is required prior to each subsequent isatuximab dose administration
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 7 days following the last dose of study treatment.
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug; post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements; male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential
PHASE II: Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug; post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements; male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 7 days prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 6 months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drugs
Persons of reproductive potential must agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped\r\n* Women of childbearing potential must have a negative serum or urine pregnancy test within 8 days prior to start of study drug administration
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Have a negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1, and agree to use contraception if they or their partner are of reproductive potential
Pregnant or lactating patients; patients of childbearing potential must agree to avoid pregnancy during study treatment and for at least two weeks after the last dose of the study drug
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; women of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Women of childbearing potential (defined as not postmenopausal [ie, ? 12 months of non-therapy-induced amenorrhea] or not surgically sterile) must have a negative serum pregnancy test within 21 days prior to initiation of Toca 511, and be willing to use an effective means of contraception in addition to barrier methods (condoms).
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to C1D1 and agree to use dual methods of contraception during the study and for a minimum of 30 days following the last treatment. Post menopausal females (>45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 30 days following the last treatment if sexually active with a female of childbearing potential.
Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; if applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs
Pregnant or nursing patients; women of childbearing potential must have a negative SERUM pregnancy test within 14 days of enrollment; women of child bearing potential must agree to use effective contraception for 14 days prior to enrollment, throughout the treatment period and for 4 to 6 months after the last dose of study treatment
Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 24 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 7 days prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient’s use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient’s understanding of GDC-0449 cause serious or life-threatening birth defects; patients must continue highly effective contraception during therapy and for 24 months after the last dose of GDC-0449\r\n* Women of childbearing potential are defined as follows:\r\n** Patients with regular menses\r\n** Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Women who have had a tubal ligation\r\n* Women are considered not to be of childbearing potential for the following reasons:\r\n** The patient has undergone hysterectomy and/or bilateral oophorectomy\r\n** The patient is post-menopausal defined by amenorrhea for at least 12 months in a woman > 45 years old\r\n* Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with GDC-0449 and for 3 months after the last dose to avoid exposing an embryo or fetus to GDC-0449
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days; women of childbearing potential and men must agree to use contraception at study entry and for the duration of active study treatment
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method during the study and for 3 months after last study drug administration
If female and of childbearing potential, have a negative serum or urine pregnancy test during screening. Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.
Women of child-bearing potential MUST have a negative serum or urine pregnancy test unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose
Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method; women of non-child-bearing potential may be included if they are either surgically sterile or have been post-menopausal for > 1 year\r\n* Note: Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to receiving therapy; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum or urine pregnancy test for women of childbearing potential within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible. Patients of childbearing potential must agree to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational medicinal product (IMP) and for 30 days after the final dose of IMP.
Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days of treatment and must practice an effective method of contraception during treatment and for at least 9 months (270 days) following the last dose of study drug.
Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug.
If a female of child-bearing potential, has a negative serum pregnancy test result within 14 days before baseline and agrees to abstain from heterosexual intercourse or use a barrier method for contraception from 14 days before baseline (C1D1) through 30 days after the last study drug dose.
Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry
Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment; male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for 3 months after treatment stops
For female subjects of childbearing potential, willingness to abstain from heterosexual intercourse or use 2 concurrent protocol recommended methods of contraception from the screening visit throughout the study treatment period and to 30 days from the last dose of pembrolizumab; a negative serum pregnancy test is required for female subjects at screening; lactating females must agree to discontinue nursing before administration of study drugs
If female: not breastfeeding; agrees to not attempt to become pregnant during the study; is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within 24 hours.); if of childbearing potential (including being < 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and for ? 28 days after the last dose of any study therapy (IV or oral)
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and must agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment
Female patients of childbearing potential must have a negative pregnancy test and agree to use two forms of acceptable contraceptive measures from the time of consent through 120 days after discontinuation of study drug administration.
Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry (within 72 hours prior to initiation of study treatment) and be practicing an effective form of contraception; women should not breast-feed while on this study
If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy
Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception
Women of childbearing potential must have a negative serum pregnancy test within 7 days from day 1 of study drug; both men and women must be willing to use two methods of contraception, one of them being a barrier method during the study and for 6 months after last study drug administration
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
Pregnant and/or breastfeeding; women of childbearing potential must have a negative serum pregnancy test within 28 days of study entry; female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraceptive during the period of the trial and for at least 90 days after completion of treatment; the decision of effective contraception will be based on the judgment of the principal investigator or a designated associate
Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; reliable contraception should be used from trial screening and must be continued throughout the study; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study.
A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
Women and men of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
Female patients of childbearing age must have negative urine or serum pregnancy test; subjects agree to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of brentuximab vedotin
men and women must agree to the use an effective method of contraception during the study and for at least 3 months post last dose of study drug administration. Women of child-bearing potential must have negative serum and urine pregnancy tests at screening and during each treatment cycle, respectively
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study participation
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, during the study and for 7 days following the last dose of study treatment.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days from day 1 of study drug; both men and women must be willing to use two methods of contraception, one of them being a barrier method during the study and for 4 months after last study drug administration
Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study; female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study
A woman of childbearing potential who agrees to use a highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) as detailed in in Appendix VII of this protocol 2 weeks before start of first dose of study treatment, during the treatment period and for at least 4 weeks after the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test (?-HCG test in serum) prior to enrollment.
Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment.
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 12 months following the last dose of the study drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs
Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use effective contraception, during the study and for 30 days following the last dose of study treatment.
Negative serum pregnancy test done =< 7 days prior to registration/randomization, for women of childbearing potential only\r\n* Note:\r\n** Females: adequate contraception must be used by both patient and partner while receiving study drug and for 12 weeks after the last dose of study drug\r\n** Males: adequate contraception must be used by both patient and partner while receiving study drug; men who have a partner of childbearing age should also avoid fathering a child for 6 months after the last dose of study drug
Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab and/or olaparib
Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Women must not be pregnant or lactating; women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use an effective method to avoid pregnancy during and for 30 days following last cessation drug dose
Female Subjects of Childbearing Potential: Subjects must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agrees to use effective contraception, throughout the treatment period and for 4 months after the last dose of study treatment.
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment; women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test; if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol; women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment
Women of child-bearing potential (WOCBP) must have a negative pregnancy test prior to enrollment and within 14 days of the first administration of study treatment, and must also agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
Women of childbearing potential must have a negative serum pregnancy test within 14 days before the first dose of study treatment and agree to use effective contraception during the study; NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with dabrafenib.
Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
Pregnancy or nursing mothers; women of childbearing potential must have a negative pregnancy test and must agree to use adequate contraception prior to study entry and for the duration of study participation
Women of childbearing potential must have a negative pregnancy test during Screening and must agree to use highly effective physician-approved contraception from Screening to 90 days following the last study drug administration
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol, during the study and for 7 days following the last dose of study treatment.
Subjects of reproductive potential must agree to the use of acceptable contraceptive methods for the duration of the time on study and a further 6 months after completion of treatment; women of childbearing potential must have a negative blood or urine pregnancy test within 72 hours of start of treatment
Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (b-HCG) pregnancy test within 7 days before the first dose of study drug. Women of reproductive potential and men with female partners of childbearing potential must agree to consistently use highly effective contraception between signing the informed consent and 60 days after the last administration of study drug
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 3 months following the last dose of study treatment
A female subject is eligible to participate ifs she is of: Non-child bearing potential as described in the protocol; OR Child bearing potential and agrees to use effective contraception as described in the protocol, for an appropriate period of time (as determined by the product label) prior to the start of dosing to sufficiently minimize the risk of pregnancy and for at least 2 weeks (14 days) following the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment followed by negative urine or serum pregnancy test once every 4 weeks (prior to next dose cycle) thereafter.- Adequate organ system function as defined in the protocol. Part 2 Inclusion Criteria
female subject must have a negative serum pregnancy result within 7 days before the start of the study; Both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (?7 days prior to the first dose of Study drug) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug.
Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ?28 days prior to, during, and for ?28 days after completion of study therapy.
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for at least 3 months following the last dose of study drug. Females with childbearing potential must have had a negative serum pregnancy test 7 days before the first dose of study drug and must not be breast-feeding.
Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception; a woman is eligible to enter and participate in the study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who has had a hysterectomy or has had a bilateral oophorectomy (ovariectomy)\r\n* Childbearing potential, has a negative serum pregnancy test during the screening period and agrees to avoid sexual activity or use accepted methods of contraception from screening through follow-up\r\n* Men with a female partner of childbearing potential are eligible to enroll and participate in the study if they have had either a prior vasectomy or agree to avoid sexual activity or use appropriate barrier contraception from screening through post-treatment follow-up
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.
Pre-menopausal women must have a negative pregnancy test before study entry and agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation
Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy. Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days (females and males) following the last dose of AG-221
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception as defined in the protocol.
Pregnant and lactating women are not eligible; all participants of reproductive age must have a negative serum pregnancy test at baseline and agree to use an effective barrier method of contraception during the entire period of treatment on the study
Female patients of child bearing potential must have a negative pregnancy test (within 7 days from the time of randomization); patients must agree to use effective contraception (both males and females) for 2 weeks prior to the first dose of each study treatment and for 8 weeks after the last dose of each study treatment
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 30 days following the last dose of investigational product.
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, from 14 days prior to the first dose of study treatment, throughout the study, and for 6 months following the last dose of chemotherapy or 4 weeks after the last dose of GSK3052230, whichever is latest. .
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use effective contraception, during the study, and for 30 days after the last dose of study treatment
If female and has begun menstruating, must have a negative pregnancy test prior to study participation and agree to remain abstinent or use a barrier form of contraception
Women of childbearing potential must have a negative pregnancy test at baseline prior to receiving any study drug and must practice effective contraception while on study; (pregnant or lactating patients are excluded)
Women of child producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment and must agree to use adequate contraception prior to enrollment and for the duration of study participation; subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug
Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception during the study and for one year following the last dose of study drug.
Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
Women of childbearing potential must have had a negative pregnancy test (urine or serum) ? 7 days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for 3 months after the last dose.
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential and agrees to use contraception for the duration of the treatment cycle and for a minimum of 30-days following the end of therapy (a minimum estimate 95 days)
Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Female patients of childbearing potential must have a negative serum pregnancy test at screening and must agree to use a highly effective form of contraception from the time of the first dose of study drug through 45 days after the last dose of study drug.
Female subjects of childbearing potential (FCBP) must have a negative urine or serum pregnancy test AND must agree to use effective contraception throughout the study, starting at the first dose of chemotherapy for at least 12 months thereafter and 4 months after the gene modified cells are no longer detected in the blood, whichever is longer. Or
Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug\r\n* Childbearing potential is defined as girls who are > Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy\r\n* Urine pregnancy tests are acceptable
Nonpregnant, nonlactating female patients; patients of childbearing potential must implement an effective method of contraception during the study; all women of childbearing potential must have a pre-study negative serum or urine pregnancy test within 7 days prior to study entry
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study
A female subject is eligible to participate if she is of: Non-childbearing potential or women of childbearing potential must have a negative serum pregnancy test within 72 hours of first dose of study treatment and agree to use effective contraception during the study and for 60 days following the last dose of study treatment.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation
Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal
Women who are pregnant or breast-feeding; female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; a negative pregnancy test is required within 24 hours of administration of radiotracer and study initiation for women of childbearing age and potential
Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication.
Women of childbearing potential must have a negative serum or urine pregnancy test within 96 hours prior to start of study drug.
For women of childbearing potential (defined as women with menses within the past 2 years), a negative serum pregnancy test must be documented prior to registration; NOTE: in addition to screening, serum pregnancy test must be performed on females of childbearing potential within 72 hours before the start of investigational product; when possible, these tests can be one-in-the-same (if screening pregnancy test was performed within 72 hours of first ponatinib dose, no need to repeat)
Women of childbearing potential must have negative pregnancy test within 24 hours of enrollment
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug
Patient (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of nonchildbearing potential.
Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
Negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential.
Women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
Pregnant or nursing women. \r\n* NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to enrollment
Women of childbearing potential must have a negative serum pregnancy test at screening and =< 72 hours prior to day 1 of study treatment
Women of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the start of nivolumab.
Pregnant or nursing women; NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
Female participants of childbearing potential should have a negative serum pregnancy test within 24 hours prior to receiving first dose of trial medication.
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication
have a negative urine pregnancy test within 24 hours prior to the first dose of study treatment, and
Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose of pembrolizumab
For women of childbearing potential, a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication
Female subject of childbearing potential should have a negative serum pregnancy testing at screening visit and within 72 hours prior to the first dose of study medication
Female subject of childbearing potential should have a negative serum pregnancy within 48 hours prior to receiving the first dose of study medication
Negative serum pregnancy test for women of childbearing potential =< 7 days prior to registration; Note: a second pregnancy test may be required =< 72 hours prior to receiving the first dose of study medication
Women of childbearing potential also may not be breast feeding and must have a negative serum or urine pregnancy test within 72 hours before the start of study treatment
Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of nivolumab
Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is >= 45 years of age and has not had menses for greater than 1 year]) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 120 days following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within 72 hours of receiving study drug administration; if appropriate; contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within 48 hours prior to the study drug administration
Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of IRX5183
Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
PRIOR TO LYMPHODEPLETION: For WOCBP negative serum pregnancy test within 72 hours prior to lymphodepletion
Women of childbearing potential (defined as having a menstrual cycle within the past 12 months and not having had a surgical procedure to accomplish sterilization) must have a negative serum pregnancy test within seven days of screening and within 24 hours prior to the start of each nivolumab dose
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential
Women of childbearing potential (WOCBP) must have negative pregnancy test within 72 hours prior to day (D)1 of treatment
Negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential
For women of childbearing potential only: Negative pregnancy test =< 10-14 days prior to registration; NOTE: the patient must have an additional negative pregnancy test =< 24 hours prior to receiving the initial prescription of lenalidomide, per requirements of the REVLIMID Risk Evaluation and Mitigation Strategies (REMS) program
Female subject's of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Negative serum or urine pregnancy test within 72 hours of commencement of treatment in premenopausal women
Pregnant or nursing (lactating) women, female study participants of reproductive potential must have a negative serum or urine pregnancy test within 48 hours before infusion
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Negative serum pregnancy test with 72 hours prior to start of study drug
Negative serum pregnancy test within 72 hours prior to the first study dose in all women of childbearing potential
Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug
Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
Women of child-bearing potential must have a negative serum pregnancy test during Screening and a negative urine pregnancy test within 24 hours prior to first dose of study treatment. Non-childbearing is defined as greater than one year postmenopausal or surgically sterilized.
Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
WOCBP must have a negative pregnancy test within 24 hours prior to Study Day 0.
Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours of starting first dose of study drug.
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days and again within 72 hours prior to dosing
Female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 72 hours prior to administration of any treatment
Serum pregnancy test for female patients of childbearing potential, =< 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
For women of childbearing potential, a serum pregnancy test within 72 hours prior to registration
Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
Female participants of childbearing potential must have 2 negative urine pregnancy tests (with a sensitivity of at least 25 Milli-international units/Milliliter) within 10 to 14 days and within 24 hours prior to receiving study medication.
Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum pregnancy test at enrollment; a urine or serum pregnancy test will be performed within 48 hours before the RNA CART19 infusion
Serum pregnancy test for female patients of childbearing potential, =< 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential must have a negative serum pregnancy test within the 14-day period prior to randomization. (Where demanded by local regulations, this test may be required within 72 hours of randomization.)
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within 72 hours of receiving study drug administration; if appropriate contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within 48 hours prior to the study drug administration
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
Women of childbearing potential must have a negative serum pregnancy test during Screening Period and within 48 hours of the first dose of ARQ 087.
Pregnant or lactating women; the safety of this therapy on unborn children is not known; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
For females of childbearing potential, a serum pregnancy test within 2 weeks prior to registration; note: if pelvic irradiation is to be given, the serum pregnancy test must be repeated within 48 hours prior to registration
Female subject of childbearing potential must have a negative serum pregnancy 10-14 days prior to registration, and again within 24 hours prior to the first dose of lenalidomide
For women of childbearing potential, a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
Female subjects of childbearing potential must have a negative serum pregnancy test at screening within 96 hours prior to the first study dose.
Women of childbearing potential must have a negative pregnancy test performed within 48 hours prior to the start of the study drug
Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours.
For women of childbearing potential, a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 to 14 days and again within 24 hours of starting study drug
Female patient has a negative serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential, and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment, or be of non-childbearing potential.
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
In women of child-bearing potential (WOCBP), a negative serum pregnancy test within 72 hours prior to procurement and again 72 hours prior to infusion is required
If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine) within the 7 days prior to study drug administration, and within the 3 days before the first study drug administration, or a negative pregnancy test within the 24 hours before the first study drug administration.
Positive serum or urine pregnancy test within 24 hours of imaging prior to injection of radiotracer (for women of childbearing potential per Radiology Department clinical guidelines)
If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the restart of study drug
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to dosing.
Women of childbearing potential must:\r\n* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy\r\n* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed\r\n* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative urine pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 weeks after study drug is stopped; prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Pregnancy or breastfeeding; women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy; all WOCBP MUST have a negative pregnancy test within 4 weeks prior to registration, and this must be repeated within 72 hours prior to first receiving ruxolitinib; if the pregnancy test is positive, the patient must not receive ruxolitinib and must not be enrolled in the study
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception: postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential; women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug; all WOCBP MUST have a negative pregnancy test prior to first receiving study medication(s)
Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug; pregnant or breast-feeding women are excluded; all WOCBP must have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study
Women of childbearing potential must:\r\n* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy\r\n* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed\r\n* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
Women of childbearing potential must have:\r\n* A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration\r\n* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 26 weeks after ipilimumab is stopped; sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped; women of childbearing potential and men with a sexual partner of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception; women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product; sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; all WOCBP should be instructed to contact the investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Women of childbearing potential must have a negative serum pregnancy test within 7 days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Women of childbearing potential (WOCBP), defined above who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding\r\nNOTE: before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab or HDI; if the pregnancy test is positive, the patient must not receive ipilimumab or HDI and must not be enrolled in the study
Women of childbearing potential must have a negative serum pregnancy test within 7 days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Women of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an intentional pregnancy
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 5 months after ipilimumab/nivolumab is stopped (7 months for men)\r\n* Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab/nivolumab; if the pregnancy test is positive, the patient must not receive ipilimumab/nivolumab and must not be enrolled in the study
Pregnancy or breastfeeding; women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy; prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control; all WOCBP MUST have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study; in addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
Sexually active WOCBP must use an effective method of birth control during the course of study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Women of childbearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment; women must not be lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
Patients must not be pregnant or nursing\r\n* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
Menopausal status\r\n* Both pre- and post-menopausal patients are permitted into the study; for patients in Cohort C who are pre-menopausal, therapy with a gonadotropin-releasing hormone analogue (leuprolide acetate preferred) must be commenced at least 4 weeks before commencing trial therapy; post-menopausal status is defined either by \r\n** Prior bilateral oophorectomy\r\n** Age greater than 60\r\n** Age less than 60 years with an intact uterus and amenorrhoeic for at last 12 months. \r\n** For patients aged less than 60 years with amenorrhea for less than 12 months (including patients with prior hysterectomy, those who have received hormone replacement therapy, or those rendered amenorrhoeic by chemotherapy), follicle-stimulating hormonal (FSH) levels in the post-menopausal range define the post-menopausal state
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
ENDOCRINE RESISTANT COHORT: Pre- or post-menopausal women are eligible; if premenopausal, patient must be willing to comply with pregnancy requirements and agrees with GnRH agonist therapy for ovarian suppression during the study
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Pre- or post-menopausal women are allowed; if pre- or peri-menopausal, concurrent ovarian suppression for pre- or peri-menopausal women is required
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
ER+ and/or PR+ (Note: This group of patients must have received at least 1 and up to 3 prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER2+ patients in this group must have received a minimum of 2 lines of HER2-directed therapy in the advanced setting.) This group of patients may be pre-menopausal with ovarian suppression or post-menopausal. LHRH agonists maybe used to render ovarian suppression with post-menopausal ranges of estradiol or FSH per institutional guidelines.
Post-menopausal or undergoing ovarian suppression
Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression; pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screening
If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression; patients may have already gotten the loading dose of ovarian suppression; pre- or peri-menopausal subjects must have a negative urine pregnancy test confirmed at screening
Patients may be pre- or post-menopausal; pre-menopausal patients must be on ovarian suppression and must be adequately suppressed on luteinizing hormone-releasing hormone (LHRH) agonists with estradiol levels in the post-menopausal range\r\n* Premenopausal patients cannot be pregnant and must agree to adequate birth control in addition to ovarian suppression; agreement by the patient and/or partner to use highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception; contraception use should continue during the duration of study treatment and for at least 6 months after the last dose of study treatment
Patients must be post-menopausal based on either a history of an oophorectomy, or at least one year of amenorrhea; an elevated serum gonadotropin level can be used to confirm menopausal status in a subject with one year or more of amenorrhea
Women who are pre-menopausal must have a negative serum pregnancy test; subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy
Post- menopausal female patients, 18 years of age or greater.
Positive pregnancy test (for pre-menopausal women)
For Part 2, any menopausal status
Pre/perimenopausal women must be amenable to be treated with goserelin. All patients will be rendered post-menopausal secondary to concomitant administration of goserelin.
Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause
Post-menopausal
Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
Post-, pre- or peri-menopausal women considered to be in the post?menopausal state as defined by one of the following:
Patients must be post-menopausal women, as defined in the protocol
Any menopausal status
On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
Is not post-menopausal (defined as amenorrhea >12 consecutive months).
Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Premenopausal or peri-menopausal women.
Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)
Post-menopausal status over 1 year
Study subjects should be post-menopausal women (premenopausal women are eligible if they are on or willing to be on mandatory ovarian function suppression)
Negative serum pregnancy test within <30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause
Women for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated; women must be either post-menopausal, or premenopausal having undergone oophorectomy
Pregnant or lactating women; all pre-menopausal and peri-menopausal women should have a urine test for pregnancy within a week of starting therapy; all patients of child bearing potential should agree to use an effective contraceptive method
Post-menopausal
Negative serum pregnancy test for pre-menopausal women and women within 12 months from the onset of menopause
Negative pregnancy test for pre-menopausal women
of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post- menopausal); or,
Patients must be pre-menopausal patients within the reproductive age range
Post-menopausal women defined as either \r\n* At least 2 years without menstrual period or \r\n* Patients at least 50 years or older with serological evidence of post-menopausal status or \r\n* Hysterectomized patients of any age with follicle stimulating hormone (FSH) confirmation of post-menopausal status
Post-menopausal, defined as:\r\n* Age >= 45 with no menses for at least 2 years\r\n* Chemically induced menopause through ovarian suppression, as determined by the primary oncologist
Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
Patients who are pregnant are excluded; pre-menopausal women must have a negative pregnancy test; patients that are post-menopausal, or that have had a hysterectomy do not need to have a pregnancy test
Post-menopausal or negative urine and/or blood pregnancy test
Participants must be pre- or post-menopausal
Patients who are post-menopausal (defined as 12 consecutive months without a menstrual period)
Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy
Post-menopausal at time of diagnosis
Patients must be either post-menopausal or surgically post-menopausal
Women who are pre-menopausal must have a negative serum pregnancy test
Subject is a pregnant or nursing female; exclude the possibility of pregnancy:\r\n* By testing (serum or urine betaHCG) within 24 hours before contrast agent administration, or\r\n* By surgical sterilization, or\r\n* Post-menopausal, with minimum one (1) year history without menses
Women who are pre-menopausal must have a negative serum pregnancy test
Women who are pre-menopausal must have a negative serum pregnancy test
If a female and pre-menopausal, must have a negative pregnancy test.
Pregnancy or breastfeeding; women of childbearing potential must have a negative pregnancy test prior to undergoing MRI/PET imaging; post-menopausal status may be established by patient reported history of absence of menses over the last 12 months
For females: negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
For females: negative urine pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
For women of childbearing potential only: a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required
Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 8 days prior to registration is required
Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
Women of childbearing potential must have a negative serum or urine pregnancy test at screening
If the participant is of childbearing potential, she must have a documented negative urine pregnancy test at the time of screening and randomization and no plans to become pregnant for the duration of study participation.
Negative serum/urine pregnancy test (for women of childbearing potential)
Negative pregnancy test by urine or serum or waiver of pregnancy testing per local institutional policy within 30 days prior to randomization according to local standards for women of childbearing potential
Women of childbearing potential must have a negative urine pregnancy test at the screening visit
Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug.
Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the start of the study
Women of childbearing potential (WOCBP) must have negative urine pregnancy test within 7 days of day 1 (D1) of treatment
Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS
Patients who are pregnant or nursing; women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening
Women of childbearing potential must have a negative serum or urine pregnancy test within 10-14 days prior to enrollment
Women of childbearing potential must have a negative serum or urine pregnancy test.
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient to be eligible for trial enrolment
Pregnancy, lactation, or breast-feeding; women of childbearing potential must have a negative urine pregnancy test at screening
Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day prior to administration of the first dose of chemotherapy
If a female of childbearing potential, has a negative serum blood pregnancy test during screening and a negative urine pregnancy test within 3 days prior to receiving the first dose of study drug; if the screening serum test is done within 3 days prior to receiving the first dose of study drug, a urine test is not required; Note: Women of childbearing potential (WoCP) are any women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation; permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion; WoCP include non-women who have experienced menopause onset < 12 months prior to enrollment
Negative serum or urine pregnancy test at screening for women of childbearing potential
Urine pregnancy test is negative for women of childbearing potential, within 14 days before study treatment
A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
DONOR: Women of childbearing potential (WOCBP): Urine pregnancy testing performed within 7 days prior to stem cell mobilization
Women of childbearing potential must have a negative urine or blood pregnancy test within 14 days of study enrollment
Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential
All women of childbearing potential must have a negative urine or serum pregnancy test at screening.
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient to be eligible for trial enrollment
Negative urine or serum pregnancy test for women of childbearing potential
Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose.
Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of childbearing potential
Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of childbearing potential
PHASE I: Negative urine pregnancy test =< 3 days prior to course 1 day 1 (C1D1) (women of childbearing potential only)
Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment
Negative urine or serum pregnancy test done =< 21 days prior to computed tomography (CT) simulation, for women of childbearing potential only
Negative serum or urine pregnancy test for women with reproductive potential
Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of treatment.
Negative urine or blood pregnancy test for women of childbearing potential
Has negative serum or urine pregnancy test for subjects of childbearing potential
Women of childbearing potential who have a positive result on screening urine pregnancy test
Pregnant or lactating - women of childbearing potential should use appropriate precautions to avoid becoming pregnant; females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study treatment start
A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
Women of reproductive potential must have negative urine pregnancy test
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI
A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
Women of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to initiation of therapy
A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
Negative pregnancy test (urine or serum), within 7 day prior to day 1 of FOLFIRI in women of childbearing potential
For women of childbearing potential, negative urine or serum pregnancy test within 6 weeks prior to study entry
Women of childbearing potential who are not using an effective method of contraception are excluded; women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS
Women who are able to conceive and unwilling to practice and effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
Negative serum or urine pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
6. Women must not be pregnant or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration.
Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to initiation of treatment AND confirmed prior to initiation of treatment on day 1
Women who are pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of nivolumab.
A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
Negative urine or serum pregnancy test for women of childbearing potential within 7 days prior to study entry
Negative pregnancy test (either urine or serum) within 14 days prior to randomization for all women of childbearing potential (above)
Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the administration of the first study treatment; women must not be lactating
For women of childbearing potential, a negative serum or urine pregnancy test
Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test)
Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test within 7 days of day 1 (D1) of treatment
Patients with a negative pregnancy test (urine or serum) must be documented within 28 days of starting treatment for women of childbearing potential (WOCBP)
A urine pregnancy test (within 7 days of enrollment date) is required for women with childbearing potential
Postmenopausal or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to start of IPs
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to receiving study agents
Negative urine or serum pregnancy test done =< 7 days prior to registration/randomization, for women of childbearing potential only\r\n* NOTE: in the rare case that a woman enrolling on study is of childbearing potential, a pregnancy test is required prior to enrollment on study
Negative serum or urine pregnancy test within 2 weeks prior to registration for women of childbearing potential
Women of childbearing potential must have a negative serum or urine pregnancy test at Screening
If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
Women of childbearing potential must have a negative serum or urine pregnancy test at screening
Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Women of childbearing potential must have a negative serum/urine pregnancy test
Women of childbearing potential must have negative blood or urine pregnancy test at screening
Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment
Negative urine or serum pregnancy test in women with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization), within one week prior to initiation of treatment
Women of childbearing age must have a negative serum or urine pregnancy test prior to the initiation of study drug.
Women of childbearing potential must have a negative serum or urine pregnancy test upon study entry
Serum or urine pregnancy test (for women of childbearing potential) negative =< 7 days of starting treatment
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1;
Women of childbearing potential (not surgically sterilized or at least 2 years postmenopausal) must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment
Women of childbearing potential must have a negative serum or urine pregnancy test performed ? 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.
Negative urine pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without urine pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year
Women of reproductive potential must have negative urine pregnancy test
Pregnant or breast-feeding women; women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment
Negative urine pregnancy test for women of childbearing potential
Urine pregnancy test for women of childbearing potential (defined as not post-menopausal for 12 consecutive months or no previous surgical sterilizations); a negative urine pregnancy test is required within 48 hours of initiating study drug
For women of childbearing potential, have a negative pregnancy test (serum or urine) on Day 1 prior to initiating study treatment.
Serum or urine pregnancy test negative within 2 weeks for women of childbearing potential
Women of childbearing potential must have a negative pregnancy test (urine or serum) performed within 7 days prior to the start of study drug.
Patients who are pregnant or nursing; women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening
Negative pregnancy test (urine dipstick or serum) for women of childbearing potential within 2 weeks prior to registration
Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must be available before study drug administration
Women of childbearing age must have a negative urine pregnancy test
Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the start of SL-701 treatment.
Women of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment
Women of childbearing potential must have a negative urine pregnancy test performed within 7 days before start of study treatment
Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to administration of everolimus
Negative serum or urine pregnancy test for women of childbearing potential only
Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment
Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration and confirmation they are not nursing is required
In addition, women of childbearing potential must consent to use adequate contraception throughout protocol therapy; females of childbearing potential must have a negative urine pregnancy test =< 7 days prior to registration
Women of childbearing potential must have a negative urine pregnancy test at screening, and
If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)
Negative (serum or urine) pregnancy test, for women of childbearing potential only
Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days prior to the first study intervention
Women of childbearing potential must have a negative urine or serum pregnancy test
Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =< 7 days prior to registration/randomization for women of childbearing potential
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization
Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT imaging per institution’s standard of care.
Women of reproductive potential must have a urine pregnancy test day of injection
Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant
Pregnant and/or breastfeeding; women of childbearing potential must have a negative urine or serum pregnancy test no more than 3 days prior to FDOPA injection
ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to first PET/MRI
Woman of childbearing potential, a negative serum or urine pregnancy test
Woman of childbearing potential, a negative serum or urine pregnancy test
If of childbearing potential, negative pre-treatment urine or serum pregnancy test
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
Pregnant or breastfeeding (negative serum or urine pregnancy test required for women of childbearing potential), or unable to maintain use of contraception while on study and for 60 days after the last dose of avelumab
Women of childbearing potential will be required to have a urine pregnancy test
Negative urine pregnancy test for women of childbearing potential within 7 days of baseline [D10]phe dosing
Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan
Negative serum or urine pregnancy test must be obtained within 7 days prior to the first dose of study drug in women of childbearing potential. Negative results must be available prior to study drug administration. Pregnancy tests will be repeated regularly during treatment
Pregnant women. Women of reproductive potential must have a negative serum or urine pregnancy test performed within 7 day
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female child-bearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of child-bearing potential, as defined above, must have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
COHORT 1: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
COHORT 2: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
SAFETY RUN-IN: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of treatment registration; female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of HiDAC treatment and again prior to D1 of pembrolizumab treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
INCLUSION CRITERIA FOR STRATUM C: Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and agree to use effective contraception; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of DCBA; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first study treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential as defined in Section 5.7.2 must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication or study indicated ultrasound treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication for female subjects of childbearing age
Female subject of childbearing potential should have a negative urine or serum pregnancy within 3 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
STUDY TREATMENT: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy at screening and within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, pembrolizumab (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Participants of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential require a negative pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours of study enrollment up to administration of the dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of pembrolizumab; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours of study enrollment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential has a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the patient to be eligible
Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to first doses of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours of receiving first dose of study treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test < 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of child-bearing potential (intact uterus) MUST have a negative serum or urine human chorionic gonadotropin (HCG) test within 72 hours prior to receiving the first dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential should have a negative urine or serum pregnancy test within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have two negative urine or serum pregnancy test, one at 10-14 days before first dose of study drug and another within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and subject also should agree to use an adequate method of contraception starting with screening through 30 days after the last dose of study therapy (if sexually active).
Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as (by other than medical reasons):
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving retreatment with study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential as defined in Section 5.7.2 must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential (WOCBP).
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of child-bearing potential (intact uterus) should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide: the first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for cycle 1 (prescriptions must be filled within 7 days)
Have a negative result confirmed for a medically supervised urine (or serum) pregnancy test (with a sensitivity of at least 25 mIU/mL) 10-14 days prior to the first dose of IP. A second pregnancy test performed within 24 hours prior to the first dose of IP must also be confirmed to be negative prior to IP administration.
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable)
Women must not be pregnant or breastfeeding; females of childbearing potential should have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL); the first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing lenalidomide
Female subjects with reproductive potential must agree to undergo a medically supervised pregnancy test prior to starting study drug. The first pregnancy test will be performed at screening (within 7 days prior to first study drug administration). A pregnancy test should also be performed on the day of the first study drug administration and confirmed negative prior to dosing as well as before dosing on Day 1 of all subsequent cycles
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for cycle 1 (prescriptions must be filled within 7 days)
For females of childbearing age, they may participate it they: a. have a negative serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy test will be performed within 24 hours (hrs) of starting therapy and both negative pregnancy tests will be required for starting therapy); b. agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to study entry
If subject is a female of childbearing potential (FCBP),† she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide
Negative (serum or urine) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative
Women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 days and again within 24 hours prior to beginning study treatment
All subjects and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female Children of Childbearing Potential, defined as females who have achieved menarche and/or breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Amenorrhea following cancer therapy does not rule out childbearing potential): - Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of 25 mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within 10 - 14 days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within 24 hours prior to starting treatment with lenalidomide. NOTE: The pregnancy test 10 to 14 days prior to initiation of lenalidomide may be omitted, at the discretion of the investigator, for any FCCBP/FCBP who has high acuity disease requiring immediate treatment with lenalidomide. The pregnancy test within 24 hours prior to the first dose of lenalidomide is required to be performed. The subject may not receive Investigational Product (IP) until the Investigator has verified that the results of these pregnancy tests performed on Cycle 1 Day 1 are negative. FCCBP/FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study Treatment Discontinuation Visit, and at Day 28 following IP discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study Treatment Discontinuation Visit, and at Days 14 and 28 following IP discontinuation.
Have 2 negative pregnancy tests as verified by the Investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence[2] from heterosexual contact.
Agree to have a medically supervised serum pregnancy test with sensitivity of at least 25 mIU/mL obtained at Screening. A serum pregnancy test is to be performed within 72 hours prior to Day 1 of starting study therapy on Cycle 1 Day -6, and within 72 hours prior to Day 1 of every subsequent cycle, and at the Treatment Discontinuation Visit. The subject may not receive IP until the Investigator has verified that the result of the pregnancy test is negative.
Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL); (Note that the screening serum pregnancy test can be used as the test prior to starting IP in the pharmacokinetics phase if it is performed within the 72-hour timeframe), and
Pregnant and/or breastfeeding; women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide
FCBP must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within 10-14 days before day 1 cycle 1 and the second pregnancy test must be performed within 24 hours of day 1 cycle 1; the subject may not receive lenalidomide until the treating investigator has verified that the results of these pregnancy tests are negative, and must agree to ongoing pregnancy tests; for patients already on Revlimid, continuation of current testing schedule is permitted as long as it is not interrupted during the transition to CRd therapy
All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
A FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug; the first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing the study drug; the subject may not receive study drug until the investigator has verified that the results of these pregnancy tests are negative
Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
Have two negative pregnancy tests as verified by the investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence2 from heterosexual contact.
Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP. Note that the screening serum pregnancy test can also be used as the test prior to starting IP (Investigational Product) if it is performed within the 72-hour timeframe.
Negative serum pregnancy test within 30 days prior to registration for females of childbearing potential.
Negative pregnancy test of females with childbearing potential.
Females of childbearing potential must have a negative serum pregnancy test
For all females of childbearing potential, a negative serum pregnancy test must be obtained within 3 days prior to starting study treatment
A negative pregnancy test (for females of childbearing potential)
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Have a negative pregnancy test result at Screening for females of childbearing potential
Negative pregnancy test for females of childbearing potential
Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of first cycle of therapy
Serum or urine pregnancy test (for females of childbearing potential) negative ?7 days of starting treatment
Have a negative pregnancy test result at Screening for females of childbearing potential
Negative urine or serum pregnancy test for females of childbearing potential
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Serum/urine pregnancy test (for females of childbearing potential) that is negative within 72 hours prior to initiation of first dose of treatment (a patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active)
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Females of childbearing potential must have a negative pregnancy test within 21 days prior to Study Day 0.
Serum or urine pregnancy test (for females of childbearing potential) negative at screening and at the baseline visit (before the patient may receive the investigational product)
Pregnant females are excluded; females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
For females of childbearing potential, a negative urine pregnancy test must be documented prior to randomization.
Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to the start of treatment
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Females of childbearing potential must have a negative pregnancy test within 30 days prior to randomization. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
Females of childbearing potential must have negative results for pregnancy test performed:
Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of apheresis
DONOR: Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of apheresis
Serum/urine pregnancy test (for females of childbearing potential) that is negative at screening and immediately prior to initiation of treatment (first dose).
Serum pregnancy test (for females of childbearing potential) negative at screening
Females with childbearing potential must have had a negative urine or serum pregnancy test =< 7 days before the first dose of deferasirox and must also not be breastfeeding
Negative pregnancy test in females of reproductive age
Pregnant or breast feeding; females of childbearing potential must have a negative pregnancy test prior to starting therapy
Females of childbearing potential must have a negative pregnancy test and agree to use contraception during on-study protocol treatment.
Serum or urine pregnancy test (for females of childbearing potential) negative =< 7 days of registration
ENTRECTINIB EXCLUSION CRITERIA: Females of childbearing potential must have a negative serum pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study
Females of childbearing potential must have negative serum or urine pregnancy test.
Females with childbearing potential must have a negative serum pregnancy test within 14 days prior to treatment start
For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
For females of childbearing potential, a negative serum pregnancy test must be documented within 72 hours of receiving the first dose of vorinostat
DONOR: Pregnant females\r\n* NOTE: a serum or urine pregnancy test for females of reproductive potential must be conducted within 7 days prior to initiation of recipient’s conditioning regimen
Females of childbearing potential must have a negative urine pregnancy test at screening and be willing to have additional urine pregnancy tests during the study; females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy
Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG
Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 14 days prior to starting study treatment
Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non-childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)
Females of childbearing potential must have a negative serum ?-Hcg pregnancy test result within 7 days of first study dose. Female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have ?- Hcg pregnancy test waived.
For females of childbearing potential, a negative pregnancy test must be documented prior to randomization
Females of childbearing potential must have negative serum or urine pregnancy test within 7 days prior to study entry; the effects of lapatinib on the developing human fetus are unknown; however, bevacizumab is known to be teratogenic and detrimental to fetal development and endometrial proliferation, thereby having a negative effect on fertility
Pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test prior to starting therapy
For females, a negative pregnancy test
Negative serum or urine pregnancy test (females of childbearing potential only).
DONORS: Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of mobilization start
Females of childbearing potential must have a negative serum pregnancy test at screening
Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Pregnant females are excluded from this study; all females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration
Negative pregnancy test for females of childbearing potential
Females of childbearing potential that do not have a negative pregnancy test.
Negative Serum pregnancy test for females of childbearing potential
A negative pregnancy test (for females of childbearing potential).
Females with childbearing potential: Have had a negative serum pregnancy test ?7 days before the first dose of study drug and also must not be breastfeeding.
Females of childbearing potential must have a negative serum pregnancy test
Females of childbearing potential have a negative serum pregnancy test (preceding 72 hours of first day of BBI608 treatment).
Females of childbearing potential must have a negative serum or urine pregnancy test prior to patient registration
Negative serum pregnancy test in females of childbearing potential
Negative pregnancy test for females of childbearing potential
Females of childbearing potential must have a negative serum pregnancy test
Negative pregnancy test for females of childbearing potential
For females of childbearing potential, must have a negative pregnancy test
Females of childbearing potential must have a negative serum pregnancy test within 14 days of treatment
Females of childbearing potential must have a negative pregnancy test within 30 days prior to randomization. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment.
Pregnant as determined by a positive serum pregnancy test within 14 days prior to registration on study (for females of childbearing potential)
Females of childbearing potential must have a negative serum or urine pregnancy test at screening
Females of childbearing potential should have a negative pregnancy test
Females of childbearing potential have a negative serum pregnancy test.
Negative urine or serum pregnancy test for females of childbearing potential
Females who are breastfeeding or pregnant. For females of childbearing potential, a negative screening pregnancy test must be obtained within 72 hours before the first dose of study drug
For females with reproductive potential: a negative serum pregnancy test
Females of childbearing potential must have a negative serum pregnancy test
Females of childbearing potential must have a negative serum pregnancy test.
Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Negative pregnancy test in females of reproductive age
Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Females of childbearing potential must have a negative pregnancy test (by serum beta-HCG) within 7 days prior to the start of treatment.
Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.
Females of childbearing potential must undergo pregnancy testing based on the frequency outlined in Pregnancy Prevention Risk Minimization Plan and pregnancy results must be negative.
Negative serum pregnancy test in females of childbearing potential
Negative serum pregnancy test for females
Females of childbearing potential must have a negative pregnancy test at screening; patients taking oral contraceptives should use an additional method of contraception
Negative pregnancy test for Females of childbearing potential.
Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of ipilimumab
Females of childbearing potential must have a negative serum pregnancy test
Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding.
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine pregnancy test within 72 hours or serum pregnancy test within 2 weeks of signing the informed consent document
Females of childbearing potential must have a negative serum pregnancy test at screening
Females of childbearing potential have a negative pregnancy test within 72 hours prior to initiating study drug dosing
Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Pregnancy or nursing: All females of childbearing age must have a negative serum or urine pregnancy test < 7 days before study drug administration
For females of childbearing potential, a negative serum pregnancy test must be documented prior to enrollment
Serum pregnancy test negative for females of childbearing potential
Females of childbearing potential must have a negative pregnancy test; sexually active patients must agree to use contraception prior to, during, and 30 days after last dose
Females of childbearing potential must not be pregnant or breastfeeding on admission for conditioning for SCT and a pregnancy test will be required for all females of child-bearing potential
Negative serum pregnancy test at the time of enrollment for females of childbearing potential
Negative serum pregnancy test for females of childbearing potential
Females of childbearing potential must have a negative serum pregnancy test
Negative serum pregnancy test for females of childbearing age (11- 55 years) and/or lack child-bearing potential
All females of childbearing age must have a negative pregnancy test before beginning the study