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 should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
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 and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 72 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of nivolumab; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of nivolumab
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
The following categories are ineligible:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments
Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test must be obtained within 14 days prior to registration\r\n* Women of childbearing potential must use adequate contraception from study start to one month after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence; men must practice complete abstinence or agree to use an adequate contraception method from study start to one month after the last dose of protocol therapy
Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trialtreatment on this study and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 180 days after the completion of all treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding are also excluded.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion
Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during the treatment portion of the study and for 4 months after completion of hetIL-15 administration.
Women of childbearing potential (including those who have had a tubal ligation) must have a documented negative pregnancy test within 14 days prior to planned initiation of taselisib; women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form on nonhormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment
Women of childbearing potential and male participants agree to practice adequate contraception
Fertile men or women unwilling to use contraceptives during and for up to 12 months following treatment
Men and women ?18 years.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 8 weeks after the final dose
Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
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 2 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for 12 months following study drug administration
Men or women of childbearing potential unwilling to employ adequate contraception
Men whose sexual partners are women of childbearing potential not using a double method of contraception during the study and 3 months after the end of treatment; one of these methods must be a condom
Unwilling to employ adequate contraception
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Men or women of childbearing potential who are unwilling to employ adequate contraception
Fertile men or women who are unwilling to use contraceptives during HCT and up to 12 months post-treatment
Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year; men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product; women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception for 23 weeks after the last dose of investigational drug; men who are sexually active with WOCBP must use any contraceptive method(s) with a failure rate of less than 1% per year for 31 weeks after the last dose of investigational drug; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
PHASE II INCLUSION CRITERIA: Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception for 23 weeks after the last dose of investigational drug; men who are sexually active with WOCBP must use any contraceptive method(s) with a failure rate of less than 1% per year for 31 weeks after the last dose of investigational drug; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
Pregnancy or lactation; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
For men and women of child-bearing potential, willing to use adequate contraception (e.g., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
Women of childbearing potential (WOCBP) or sexually active men must use appropriate method(s) of contraception.\r\n* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception while on study treatment; WOCBP should use an adequate method to avoid pregnancy during study treatment and for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug\r\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception during study treatment and for a period of 7 months after the last dose of investigational product \r\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile), as well as azoospermic men do not require contraception
For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential should be willing and able to use medically acceptable forms of contraception during the trial
Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception
Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception
Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception. All patients (men and women) must agree to use an effective method of contraception (if applicable) up to three months after treatment discontinuation.
Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment
Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 1 week (women) or 12 weeks (men)
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 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
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; 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 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate but is generally defined as a hormonal or barrier method of birth control, or abstinence
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception for at least three months after completing study treatment
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961 (expected to be greater than 5 half-lives from pre-clinical data)
Women of childbearing potential (WOCBP), 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 8 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men and women who:\r\n* Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women who:\r\n** Have a positive pregnancy test at baseline, or\r\n** Are pregnant or breastfeeding
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel; all men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment
Pregnant women, nursing mothers or women of child-bearing potential who are unwilling to use medically accepted methods of contraception
Pregnant or breast-feeding women; women of childbearing potential with either a positive or no pregnancy test at baseline; woman or men of childbearing potential not using a reliable and appropriate contraceptive method; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
Women of childbearing potential must agree to follow instructions for acceptable contraception from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.
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.
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
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
Men or women of childbearing potential who are unwilling to employ adequate contraception
Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception as stated for the timeline below
Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception.
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. Appropriate methods of contraception are as follows. Women will be instructed to adhere to contraception for a period of 26 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 35 weeks after the last week of nivolumab/ipilimumab (nivo/ipi). Note: WOCBP is defined as any female who has experienced menarche and who has not yet undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented negative serum or urine test.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 35 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
Women of childbearing potential or men who is unwilling to use an appropriate method of contraception during the study period and for 6 months after completing treatment with Debio 1347; oral or injectable contraceptive agents cannot be the sole method of contraception
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
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 4 months for both females and males after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation
Women of childbearing potential (WOCBP) and sexually active, non-sterile men must be willing to use acceptable method of contraception; WOCBP must agree to not get pregnant and sexually active, non-sterile men must agree not to impregnate a woman for at least 18 weeks after the last dose of nivolumab
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception for at least 3 months after the last dose of the study drug
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.
Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 7 months after final nivolumab study treatment
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Negative serum pregnancy test in women of childbearing potential within 7 days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during and after 90 days post dose. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices.
Women of childbearing potential and fertile men unwilling to use effective contraception during study until 4 months after conclusion of the treatment period
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential not willing/able to use contraception during protocol treatment
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of\r\ninvestigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Pregnant women, women of childbearing potential not willing to use contraception, men who are sexually active and not willing/able to use medically acceptable forms of contraception, and breast-feeding women not willing to stop breastfeeding during the study
Women of child bearing potential (WOCBP) should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug(s); Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; Women who are not of childbearing potential as well as azoospermic men do not require contraception
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.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product; women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
All patients (men & women) of childbearing potential should use a method of birth control that is effective for them throughout their participation in this study. Women of childbearing potential should use an adequate contraceptive method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours before the start of nivolumab; and must not be breastfeeding. Men who are sexually active with women of childbearing potential must use a contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab will be instructed to use contraception for 7 months after the last dose of nivolumab. Women who are not of childbearing potential (i.e. are postmenopausal or surgically sterile) & azoospermic men do not require contraception
All patients (men & women) of childbearing potential should use method of birth control that is effective for them throughout their participation in this study. Women of childbearing potential should use an adequate contraceptive method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after last dose of investigational drug; must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours before the start of nivolumab; and must not be breastfeeding. Men who are sexually active with women of childbearing potential must use a contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab will be instructed to use contraception for 7 months after the last dose of nivolumab. Women who are not of childbearing potential (i.e., are postmenopausal or surgically sterile) and azoospermic men do not require contraception
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product; women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
Women of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator
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
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
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 2 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Age and reproductive status:\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* WOCBP must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug\r\n* Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to registration\r\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year\r\n* Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product\r\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile and azoospermic men are not required to use contraception
Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.
Any of the following:\r\n* Pregnant women or women of reproductive ability who are unwilling to use effective contraception\r\n* Nursing women\r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide)\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
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 should use an adequate method to avoid pregnancy for 23 weeks) after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
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
Men who are unwilling to employ adequate contraception measures during the study and for 30 days after the final dose of study therapy
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential must be non-pregnant and non-lactating and willing to use highly effective form of contraception during radiation therapy
Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and men must agree to use adequate contraception
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 who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after completion of treatment
Pregnant and breastfeeding women are excluded; women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded; this applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum follicle stimulating hormone [FSH] levels greater than 35 mIU/mL); a negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential; male subjects must also agree to use effective contraception for the same period as above
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling or unable to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to enrollment and initiation of treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential, who are unwilling to employ adequate contraception as determined by treating physician, while on this study and for 6 months after the end of treatment with the study drugs
Women who are pregnant or breast-feeding; NOTE: Premenopausal women on ovarian suppression therapy are still considered of childbearing potential; women of childbearing potential and men must be strongly advised to use an accepted and effective method of non-hormonal contraception; acceptable contraception includes barrier methods (e.g., condoms or diaphragm) or intrauterine devices (IUDs) (these may include low-dose hormones at the discretion of the study chair)
Any of the following because this study involves an agent where the genotoxic, mutagenic and teratogenic effects are unknown:\r\n* Pregnant or breastfeeding\r\n* Patient of childbearing potential who is unwilling to employ adequate contraception
Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 3 months after the last dose of study drug
Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for 90 days after the last dose of study therapy (durvalumab or JCAR014)
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
For men and women of child-bearing potential, willing to use adequate contraception
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
Men and women must be willing to use appropriate contraception throughout study and for 6 months after
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential must
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
Since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown, any of the following will deem the subject ineligible for the study:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
DONOR: Women of childbearing potential and men must agree to use adequate contraception with two different forms, including one barrier method, during participation in the study and for 2 weeks following dosing with BL-8040; abstinence is acceptable if this is the established and preferred contraception for the subject
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women participate in the study must be surgically sterile, post-menopausal, or women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation and after for a certain amount of time\r\n* The individual methods of contraception and duration should be determined in consultation with the investigator; the duration of mandatory contraception is based on clearance of the investigational drug (5 half-lives after treatment completion); for women, an additional 30 days is required to complete an ovulatory cycle; calculation of duration of mandatory contraception: the half-life of cisplatin is 20-30 minutes, half-life of methotrexate is 8-15 hours and half-life of gemcitabine is 42-94 minutes; thus, contraception is required for up to 5 weeks after the last treatment for women of child-bearing potential\r\n* Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of transarterial chemoperfusion treatment\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks 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 and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within 2-6 weeks prior to treatment
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
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
Pregnant women and women of childbearing potential are excluded from this study
Women of childbearing potential and men should agree to use adequate contraception prior to study entry and for the duration of study participation and women who are breast feeding are excluded from the study; both women and men should be fully informed of the lack of reproductive toxicity testing, and women must have a negative pregnancy test prior to enrollment
Breastfeeding, pregnant, women of childbearing potential not using contraception
Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n* NOTE: patients unwilling or unable to do any of the following are also excluded:\r\n** Men must agree to use a latex condom during sexual contact with a female of child-bearing potential even if they have had a successful vasectomy\r\n** Women of child bearing potential must agree to use 2 methods of reliable contraception simultaneously\r\n** All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment
Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device [IUD], diaphragm, abstinence, or condoms by their partner) over the entire course of the study; women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding
Women of childbearing potential
Women of child-bearing potential and men must be willing to use adequate contraception during the entire study and for 8 weeks following completion of all chemotherapy on study; this includes hormonal or barrier method, or abstinence
Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy
Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test at baseline; women/men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom); (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential); patients must agree to continue contraception for 30 days from the date of the last study drug administration
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
Male patient whose sexual partner(s) are women of childbearing potential who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception.
Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment
Nursing women, women of childbearing potential with positive blood pregnancy test within 30 days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device [IUD], diaphragm, abstinence, or condoms by their partner) over the entire course of the study
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ highly effective contraception while on study treatment and for 6 months after the final dose of treatment; NOTE: women of childbearing potential are defined as all women physiologically capable of becoming pregnant\r\n* Men of childbearing potential who are unwilling to employ highly effective contraception while on study treatment and for 6 months after the final dose of treatment and should not father a child during this time; NOTE: men of childbearing potential are defined as all males physiologically capable of conceiving offspring
Women of childbearing potential and male participants must agree to practice adequate contraception
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
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; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days prior to the first vaccine, within 24 hours prior to the first and second doses of vaccine and prior to surgery\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 1 year in a woman > 45 years old
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
Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception
Men and women aged 18 years and over
Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Subjects of childbearing potential who are unwilling to take appropriate precautions (from screening through follow-up) to avoid becoming pregnant or fathering a child; females of non-childbearing potential are defined as women who a) are 55 years of age with history of amenorrhea for 1 year OR b) are surgically sterile for at least 3 months; for females of childbearing potential, or for males, pregnancy must be avoided by taking appropriate precautions; these precautions and the methods of contraception should be communicated to the subjects and their understanding confirmed
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
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
Sex and reproductive status:\r\n* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug\r\n* Women who are pregnant or breastfeeding\r\n* Women with a positive pregnancy test\r\n* Sexually active fertile men not using effective birth control if their partners are WOCBP
Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for at least 3 months thereafter; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cisplatin
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) who: (a) are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for up to 26 weeks after cessation of study drug, or (b) have a positive pregnancy test at baseline, or (c) are pregnant or breastfeeding
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Men or women.
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
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men or women not using effective contraception
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
Women of childbearing potential and sexually active males should use effective contraception while on study
Women of childbearing potential and sexually active males should use effective contraception while on study
Pregnant women may not participate; women of childbearing potential and sexually active males will be advised to effective contraception while on study
Pregnant women may not participate; women of childbearing potential and sexually active males will be advised to use effective contraception while on study
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP-partner(s) not using and not willing to use a highly effective method of contraception.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant or lactating women; women of childbearing potential must use effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-128.
Pregnant women, nursing mothers or women of child-bearing potential who are unwilling to use medically accepted methods of contraception
Women of child-bearing potential and men must agree to use adequate contraception prior to the start of treatment, for the duration of treatment, and for 5 months after last dose of study treatment
For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
Any of the following:\r\n* Nursing women\r\n* Pregnant women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
Women of childbearing potential and sexually active males must commit to the use of adequate contraception from the study start to one year after the last dose of study treatment
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
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
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception.
Men or women.
Teratogenic effects of cenersen are unknown, women of child-bearing potential & men must agree to use adequate contraception prior to study entry & for the duration of study participation.
Women of childbearing potential and men must agree to use adequate contraception
For Part 1, postmenopausal women only
Signed written informed consent forms HLA SCREENING: • Women of childbearing potential must use adequate contraception MAIN SCREENING:
Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant who are unwilling to use highly effective methods of contraception throughout the study and 15 days after study drug discontinuation
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
Men or women of reproductive ability who are unwilling to use effective contraception and women of childbearing potential who are unwilling to undergo pregnancy testing before and during the study.
Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation
Any of the following:\r\n* Pregnant individuals\r\n* Nursing individuals\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
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.
Pregnant or lactating women; women of childbearing potential not using a reliable and appropriate contraceptive method; postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients will agree to continue the use of acceptable form of contraception for 30 days from the date of last drug administration
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry 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 ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving treatment with guadecitabine, LDAC, or IC and for at least 3 months after completing treatment.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to registration\r\n* Note: women of child-bearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 4 months after the last dose of study therapy
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 6 months after the last dose of cetuximab or MEDI14736 (durvalumab); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic; women who are breastfeeding are also excluded
Women of child bearing potential and men must agree to remain abstinent or use adequate contraception (failure rate < 1%) for the duration of study and for 90 days after the completion of the therapy
Female patients of childbearing potential and men receiving MK-3475 (pembrolizumab) who are sexually active with women 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 MK-3475 (pembrolizumab); note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of treatment
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following: \r\n* Pregnant women\r\n* Nursing women \r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of child-bearing potential (WOCBP) 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 should use an adequate method to avoid pregnancy for 31 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following: \r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women who are pregnant or lactating, or who are of childbearing potential , and men\n             who do not use a barrier method
INCLUSION CRITERIA:\n\n        Patients must meet all of the inclusion criteria outlined below in order to be eligible to\n        participate in the study.\n\n          1. Patients with histologically and/or cytologically confirmed solid tumors who have\n             progressed after receiving approved therapies for their disease and for whom no\n             effective therapies are available.\n\n          2. Surgery and radiotherapy must have been completed at least four weeks prior to study\n             entry, and prior chemotherapy and other anti-cancer therapy, excluding\n             bisphosphonates at a steady dose level, must have been discontinued 2 to 3 weeks\n             previously. All acute toxicities related to these treatments must have resolved.\n\n          3. Aged ? 18 years\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n          5. Written informed consent prior to any study specific screening procedures, which will\n             include mandatory consent to provide a blood sample specifically for pharmacogenomic\n             analysis, with the understanding that the patient may withdraw consent at any time\n             without prejudice. Tumor biopsy for pharmacogenomic (PG) analysis will be voluntary.\n\n          6. Willing and able to comply with the protocol for the duration of the study.\n\n          7. Anticipated life expectancy > three months.\n\n        EXCLUSION CRITERIA:\n\n        Patients with the following characteristics will not be eligible for the study.\n\n          1. Symptomatic or progressive brain tumors or brain or leptomeningeal (CNS) metastases\n             requiring clinical intervention, except if they have completed local therapy and have\n             discontinued the use of corticosteroids for this indication for at least two weeks\n             before starting treatment with E7107.\n\n          2. Any of the following laboratory parameters:\n\n               1. hemoglobin < 9 g/dL (5.6 mM)\n\n               2. neutrophils < 1.5 x 10^9/L\n\n               3. platelets < 100 x 10^9/L\n\n               4. serum bilirubin > 25 ?M (1.5 mg/dL)\n\n               5. liver function tests (defined as AST and ALT) with values > 3 x ULN (5 x ULN if\n                  liver metastases are present)\n\n               6. serum creatinine > 1.5 x ULN or creatinine clearance < 40 mL/min.\n\n          3. Positive history of HIV, active hepatitis B or active hepatitis C or\n             severe/uncontrolled intercurrent illness or infection.\n\n          4. Clinically significant cardiac impairment or unstable ischemic heart disease (greater\n             than Class II according to New York Heart Association (NYHA) classification)\n             including a myocardial infarction within six months of study start.\n\n          5. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants\n\n          6. History of alcoholism, drug addiction, or any psychiatric or psychological condition\n             which, in the opinion of the Investigator, would impair study compliance.\n\n          7. Women who are pregnant or breast-feeding. Women of childbearing potential with either\n             a positive serum pregnancy test at screening, a positive urine pregnancy test at the\n             beginning of any cycle, or no pregnancy test. Women of childbearing potential unless\n             using two forms of contraception, one of which must be a barrier method.\n             Postmenopausal women must be amenorrheic for at least 12 months to be considered of\n             non-childbearing potential.\n\n          8. Fertile men and fertile women who are not willing to use contraception, or fertile\n             men or fertile women with a partner who is not willing to use contraception\n\n          9. Patients with a marked screening or baseline prolongation of QT/QTc interval using\n             the Fridericia formula (ie, repeated demonstration of a QTc interval > 450 msec); a\n             history of additional risk factors for Torsade de Pointe (e.g., heart failure,\n             hypokalaemia, history of Long QT Syndrome).\n\n         10. Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic\n             radiation).\n\n         11. Patients who have a history of previous Grade 2 or higher hypersensitivity to\n             pladienolide B or derivatives and excipients of the formulation\n\n         12. Patients with significant comorbid disease or condition, which in the Investigator's\n             opinion would exclude the patient from the study\n\n         13. Patients who have received an organ allograft ie, requiring immunosuppressive therapy\n\n         14. Beginning two weeks prior to dosing, patients are not allowed to take drugs that are\n             strong CYP inhibitors (including grapefruit juice and herbal supplements) or inducers\n             (including herbal supplements), or are metabolized by cytochrome P (CYPs) and known\n             to have a narrow
INCLUSION CRITERIA:\n\n        Patients must meet all of the inclusion criteria outlined below in order to be eligible to\n        participate in the study.\n\n          1. Patients with histologically and/or cytologically confirmed solid tumors who have\n             progressed after receiving approved therapies for their disease and for whom no\n             effective therapies are available.\n\n          2. Surgery and radiotherapy must have been completed at least four weeks prior to study\n             entry, and prior chemotherapy and other anti-cancer therapy, excluding\n             bisphosphonates at a steady dose level, must have been discontinued 2 to 3 weeks\n             previously. All acute toxicities related to these treatments must have resolved.\n\n          3. Aged ? 18 years\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n          5. Written informed consent prior to any study specific screening procedures, which will\n             include mandatory consent to provide a blood sample specifically for pharmacogenomic\n             analysis, with the understanding that the patient may withdraw consent at any time\n             without prejudice. Tumor biopsy for pharmacogenomic (PG) analysis will be voluntary.\n\n          6. Willing and able to comply with the protocol for the duration of the study.\n\n          7. Anticipated life expectancy > three months.\n\n        EXCLUSION CRITERIA:\n\n        Patients with the following characteristics will not be eligible for the study.\n\n          1. Symptomatic or progressive brain tumors or brain or leptomeningeal (CNS) metastases\n             requiring clinical intervention, except if they have completed local therapy and have\n             discontinued the use of corticosteroids for this indication for at least two weeks\n             before starting treatment with E7107.\n\n          2. Any of the following laboratory parameters:\n\n               1. hemoglobin < 9 g/dL (5.6 mM)\n\n               2. neutrophils < 1.5 x 10^9/L\n\n               3. platelets < 100 x 10^9/L\n\n               4. serum bilirubin > 25 ?M (1.5 mg/dL)\n\n               5. liver function tests (defined as AST and ALT) with values > 3 x ULN (5 x ULN if\n                  liver metastases are present)\n\n               6. serum creatinine > 1.5 x ULN or creatinine clearance < 40 mL/min.\n\n          3. Positive history of HIV, active hepatitis B or active hepatitis C or\n             severe/uncontrolled intercurrent illness or infection.\n\n          4. Clinically significant cardiac impairment or unstable ischemic heart disease (greater\n             than Class II according to New York Heart Association (NYHA) classification)\n             including a myocardial infarction within six months of study start.\n\n          5. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants\n\n          6. History of alcoholism, drug addiction, or any psychiatric or psychological condition\n             which, in the opinion of the Investigator, would impair study compliance.\n\n          7. Women who are pregnant or breast-feeding. Women of childbearing potential with either\n             a positive serum pregnancy test at screening, a positive urine pregnancy test at the\n             beginning of any cycle, or no pregnancy test. Women of childbearing potential unless\n             using two forms of contraception, one of which must be a barrier method.\n             Postmenopausal women must be amenorrheic for at least 12 months to be considered of\n             non-childbearing potential.\n\n          8. Fertile men and fertile women who are not willing to use contraception, or fertile\n             men or fertile women with a partner who is not willing to use contraception\n\n          9. Patients with a marked screening or baseline prolongation of QT/QTc interval using\n             the Fridericia formula (ie, repeated demonstration of a QTc interval > 450 msec); a\n             history of additional risk factors for Torsade de Pointe (e.g., heart failure,\n             hypokalaemia, history of Long QT Syndrome).\n\n         10. Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic\n             radiation).\n\n         11. Patients who have a history of previous Grade 2 or higher hypersensitivity to\n             pladienolide B or derivatives and excipients of the formulation\n\n         12. Patients with significant comorbid disease or condition, which in the Investigator's\n             opinion would exclude the patient from the study\n\n         13. Patients who have received an organ allograft ie, requiring immunosuppressive therapy\n\n         14. Beginning two weeks prior to dosing, patients are not allowed to take drugs that are\n             strong CYP inhibitors (including grapefruit juice and herbal supplements) or inducers\n             (including herbal supplements), or are metabolized by cytochrome P (CYPs) and known\n             to have a narrow
Any of the following:\r\n* Pregnant women\r\n* Nursing women \r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Sexually active men with partners of women of childbearing potential must agree to practice effective methods of contraception during the study and for 6 months after the last treatment
Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Is pregnant; women of childbearing potential and male participants unwilling to practice adequate contraception
Agreement to use adequate contraception: women of child-bearing potential must use contraception prior to study entry and for six months after study participation; men that are sexually active whose partners are women of childbearing age must use condoms
Women of childbearing potential and male subjects must practice adequate contraception
Women of childbearing potential and male participants must practice adequate contraception throughout the study
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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 of child-bearing potential must agree to use adequate contraception, defined as complete abstinence from intercourse with men or two methods
Patients who are pregnant or nursing; women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception; if a patient becomes pregnant while the patient receives trametinib and/or GSK2141795, the potential hazard to the fetus should be explained to the patient
Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment
Pregnancy or women of childbearing potential, women who cannot discontinue breastfeeding and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Male patient whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration; postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential; men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential and male participants must agree to practice adequate contraception during therapy
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential and male participants who are sexually active must agree to practice adequate contraception during treatment and for 6 months post-treatment
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Female participants must have a negative pregnancy test within 7 days of entering into the study; both men and women of child bearing potential must agree to use adequate methods of contraception for the duration of the treatment; women must avoid pregnancy, and men must avoid fathering children while in the study and for 6 months following the last study drug treatment
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the trial and for 6 months after completion of treatment
Women of childbearing potential and sexually active males must use contraception while on study
Subjects who are women of childbearing potential and sexually active males must be willing to use effective contraception while on study
Fertile men or women who are unwilling to use contraceptives during HCT and up to 12 months post-treatment
Patients (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; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
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
Women of childbearing potential who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for up to 6 months following the last administration of study treatment; men who are sexually active must be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for 6 months after completion of M6620 (VX-970) administration
Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Documented willingness to use an effective means of contraception for both men and women while participating in the study
Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Non-pregnant and not nursing; men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy
Pregnancy, nursing females or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
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 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception throughout the study and for four weeks after completion of treatment or those who are using a prohibited contraceptive method
Men and women of childbearing age and potential, who are not willing to use effective contraception
Women who are pregnant or breast feeding. Fertile patients (men and women) who are not using an effective method of contraception. All patients (men and women) must agree to use an effective contraceptive measure (if applicable) up to six months after treatment discontinuation.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
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
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 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
Postmenopausal women
Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
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
Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment
Pregnant women, nursing women, men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
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
Women of childbearing potential and men must agree to use adequate 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
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Men or women of reproductive ability who are unwilling to use effective contraception or abstinence for 4 months after treatment
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within 14 days prior to entry; patients of both genders must practice birth control during treatment and for four months after treatment
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
Postmenopausal women
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Women of childbearing potential not using a medically acceptable means of contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential must implement adequate contraception in the opinion of the investigator
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential must use effective contraception
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception. Women of childbearing potential with a positive pregnancy test within 3 days prior to pheresis.
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception. Women of childbearing potential with a positive pregnancy test within 3 days prior to entry.
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961 (expected to be greater than 5 half-lives from pre-clinical data)
Women and men of reproductive potential should agree to use two effective means of birth control\r\n* For women, contraception should continue for 23 weeks after the last dose of nivolumab and 12 weeks after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body\r\n* For men, contraception should continue for 31 weeks after nivolumab and 12 weeks after dasatinib
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the consent form until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months following last treatment
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile and azoospermic men do not require contraception
Any of the following because this study involves therapy that has known genotoxic, mutagenic and teratogenic effects:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception
Fetal and newborn toxicity: any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Males or post-menarchal females who are unwilling to employ adequate contraception throughout the duration of the study and for at least 4 weeks after treatment has ended
Men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative urine pregnancy test within 2 weeks prior to first infusion
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of child bearing potential and men must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n** NOTE: 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 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Any of the following:\r\n* Pregnant women \r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\r\nNOTE: breastfeeding should be discontinued if the mother is treated with nivolumab; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; they must adhere to contraception for a period of 31 weeks after the last dose of nivolumab
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
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; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for males at least 4 months thereafter, and for females at least 3 months thereafter
Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential (WOCBP), or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial and for at least three months after the end of active therapy
Men and women ?18 years old.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men and women of reproductive potential who are not using effective birth control methods\r\nNote: women of childbearing potential must have a negative serum pregnancy test =< 7 days prior to registration/randomization; adequate contraception must be used while receiving study drug and for 12 weeks after the last dose of study drug, by both women and men and by both patient and partner; men who have a partner of childbearing potential should also avoid fathering a child for 6 months after the last dose of study drug
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to 30 days after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Men must be willing to use appropriate contraception throughout study and for 6 months after; women must be willing to use appropriate contraception throughout study and for 20 months after
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
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 3 months after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the consent form until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent; adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
Adequate contraception must be used and patients must not be pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men and women should use adequate birth control for at least thirty days after the last administration of sorafenib
Pregnant or breast-feeding women and women of childbearing age or men who are unwilling to use adequate contraception; females of childbearing age and potential (i.e., not surgically sterilized) must use a second form of contraception, including total abstinence, intra-uterine device, double-barrier contraception, or other non-hormonal form of contraception
Men and pre- and postmenopausal women are eligible
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry
Women of childbearing potential and men who participate in the study must agree to use adequate contraception (hormonal or barrier methods) before, during the study and for a period of 3 months after the last dose of chemotherapy
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
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.
Men and women of childbearing potential must be willing to us two highly effective forms of contraception while on treatment and for at least 3 months after last dose of study drug.
For women of childbearing potential: agreement to remain abstinent
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant women, women of child-bearing potential not using reliable means of contraception, or lactating women
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, intrauterine devices [IUDS], surgical sterilization, abstinence, etc); hormonal birth control methods are not permitted\r\n* Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc)
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; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Any of the following:\r\n* Pregnant women or women of reproductive capability who are unwilling to use effective contraception\r\n* Nursing women\r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 3 months after completion of study treatment
The patient is a woman who is pregnant or lactating; 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; all patients (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of childbearing potential and men must agree to use adequate contraception .
Any of the following:\r\n* Nursing women\r\n* Pregnant women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception (non-barrier method)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
Postmenopausal women
Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
Pregnant or lactating women, or adults of reproductive potential who do not agree to use adequate contraception during study treatment
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Male patient whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Women of child-bearing potential and men must agree to use adequate contraception
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with 5-azacitidine; all men and women of childbearing potential must use acceptable methods of birth control throughout the study
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant or nursing women or men/women of child-bearing potential who are unwilling to employ adequate contraception; breastfeeding should be discontinued if the mother is treated with FOLFOX-bevacizumab
Women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
Men and women aged ?18 years
Women of child-bearing potential and men must agree to use adequate contraception
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
Any of the following:\r\n* Pregnant women or women of reproductive ability who are unwilling to use 2 effective methods of contraception from the time of signing the informed consent form through 90 days after the last dose of study drug\r\n* Nursing women\r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 30 days after stopping treatment
Women of childbearing potential and male participants must practice adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Women of child-bearing potential and sexually active men must agree to use adequate contraception prior to study entry for six months following duration of study participation
Women who are pregnant or breast feeding, or women/men of reproductive potential who are not using and unwilling to practice an effective method of birth control; (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of pasireotide and RAD001)
Male patient whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Pregnant women or women of reproductive ability who are unwilling to use effective contraception during the study and for 3 months after stopping treatment
Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Men who are sexually active with women of child bearing potential must use adequate contraception upon study entry until 31 weeks after the last dose of study treatment; men who are surgically sterile or azoospermic do not require contraception
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.
Stated willingness to use contraception in women of childbearing potential.
Men or women of childbearing potential (WOCBP) who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted method of contraception
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Any of the following:\r\n* Pregnant women or women of reproductive ability who are unwilling to use effective contraception\r\n* Nursing women \r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
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.
Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
Pregnant or nursing women or women of childbearing potential unless using effective contraception as determined by the investigator
Women of child bearing potential (WOCBP) and men able to father children who are sexually active with WOCBP must agree to use acceptable contraception\r\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception\r\n* Women of childbearing potential receiving nivolumab will be instructed to use and must be willing to use appropriate method(s) of contraception for a period of 23 weeks after the last dose of investigational product\r\n* Men receiving nivolumab who are sexually active with WOCBP will be instructed to use and must be willing to use acceptable contraception for a period of 31 weeks after the last dose of investigational product
Pregnant or lactating women, or men or women not using effective contraception
Non-pregnant and non-nursing women\r\n* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment\r\n* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Women of child-bearing potential and men must agree to use adequate contraception.
Use of effective contraception by women of childbearing potental.
Men and women of childbearing potential should practice effective methods of contraception; men and women of childbearing potential are defined as: a male that has not been surgically sterilized or female that has not been amenorrheic for at least 12 consecutive months or that has not been surgically sterilized; patients must use birth control during the study and for 3 months after the last dose of study drug if they are sexually active
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use effective methods of contraception during active treatment and for the duration of the study
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
15. Men and women of childbearing potential must agree to use adequate contraception(double barrier birth control) for the duration of study therapy and for 3 months after the last dose of VS-6063.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception\r\n* NOTE: breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
Women of childbearing age must be on effective contraception
Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic
Pregnant women are excluded from this study; breastfeeding women should be excluded; women of childbearing potential and men must agree to use adequate contraception (barrier methods) before, during the study and for a period of 3 months after the last dose of the investigational agent
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
Adult men and women
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception method during treatment and for three months after completing treatment
Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Women of childbearing potential (WOCBP) who:\r\n* Are unwilling or unable to use acceptable methods of contraception to avoid pregnancy for their entire study period and for at least 5 months after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
For women of childbearing potential, agreement to use two effective forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
Women of childbearing potential (WOCBP) 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 23 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
For women of childbearing potential, agreement to use two effective forms of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential
For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Men or women > 18 years old
For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Women who are pregnant or breastfeeding, or women of childbearing potential without using dual forms of effective contraception
Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women.
Women of childbearing potential and men with female sexual partners of childbearing potential must agree to abstain from sexual intercourse or use a double barrier method to determine if a woman is of childbearing potential (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).
For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods
For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Pregnant women, nursing women, men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
For women of childbearing potential, agreement to use two effective forms of contraception
Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
Men and women 18 and older
Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
For women of childbearing potential, agreement to use two effective forms of contraception
For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Women of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and at least 3 months after the last dose of trial medication.
Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and fertile men with a WOCBP-partner not using adequate birth control.
Women must be either of non-childbearing potential or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
Any of the following because this study involves cytotoxic agents\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and men must agree to use adequate contraception prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Pregnant or breast-feeding women and women of childbearing age who are unwilling to use adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women (lactating females must agree not to breast feed while taking lenalidomide)\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with a WOCBP partner, not using adequate birth control.
Women of childbearing potential and men must agree to use adequate contraception
Men or women > 18 years old
Any of the following:\r\n* Pregnant women or women of reproductive ability who are unwilling to use 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug\r\n* Nursing women\r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 30 days after stopping treatment
Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for 4 weeks after the last AGS-16C3F infusion administration
Any of the following:      \r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for at least 6 months after treatment has ended
Any of the following:\r\n* Pregnant women or women of reproductive ability who are unwilling to use effective contraception\r\n* Nursing women - NOTE: breastfeeding should be discontinued if the mother is treated with nab-paclitaxel (Abraxane®)\r\n* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at registration until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator
Cohort A: Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
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 and male participants must practice adequate contraception
Postmenopausal women
Male patient whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception for the duration of study participation; men and women should continue to use adequate birth control after the last administration of sorafenib and TH-302 under the guidance of their treating physician
Men or women ?18 years old
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
Postmenopausal women
Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
For fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception
Women of child-bearing potential and men must agree to use adequate contraception
Any of the following are excluded:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and for 8 weeks after the last dose of study drug, by both sexes
Women of childbearing potential (WOCBP) 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 8 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Men or women ? 18 years old
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
Use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study
Pregnant or lactating women are not eligible; 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)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for up to 4 weeks following SBRT
A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal)
Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant; men should be advised to not father a child while on treatment; both women of childbearing potential and men must agree to practice effective methods of contraception
For women of childbearing potential: agreement to remain abstinent
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
Any of the following \r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects to a developing fetus or nursing child:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Men and women of childbearing potential must agree to use adequate contraception (double barrier birth control) for the duration of study therapy
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
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
Pregnant women, nursing women, and men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.)
Creatinine value greater than 2.0 for men and 1.5 for women
Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential should use effective contraception during and for two months after stopping fingolimod
Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women will be excluded if they intend to become or are pregnant or lactating; men and women will be required to take active measures to prevent pregnancy while on the study
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception
Men and women with cancer
Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc)
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 2 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n** Note: women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 33 days after finishing the last dose\r\n** Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 93 days after finishing the last dose\r\n** Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing as described in this section
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Pregnant and lactating women; women of reproductive age must be willing to use contraception during study therapy
Negative serum pregnancy test in women of childbearing potential within 7 days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during/after 3 months post dose; a woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant; this includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic
Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
Patients (both men and women) with reproductive potential not willing to use an effective method of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Note:  We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question
Postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Fertile men or women unwilling to use contraception during HCT and for 12 months afterward
Women with child-bearing potential who are not on hormonal contraception should be willing to use non-hormonal contraception (adequate barrier-type contraception or intrauterine device [IUD]) from the time the pregnancy test is performed for the duration of study participation, and 30 days after study drug cessation (for women of childbearing potential only)
Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
Postmenopausal women
Women of childbearing potential (WOCBP) must not be pregnant
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any of the following: \r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of childbearing potential and male participants must agree to use adequate contraception for the course of the study
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
women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Asymptomatic women
Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
Men and women >18 years
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 be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Postmenopausal women defined as women with:
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
Men and women, ages ?18
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 should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of treatment on the study; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab +/- ipilimumab and blinatumomab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\r\n* Note: women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Negative serum pregnancy test within 72 hours before starting study treatment for women of childbearing potential. Women of childbearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of monalizumab administration and for up to 5 months after the last dose of monalizumab.