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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Women of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least weeks following the last dose of study treatment ( half-lives of study drug plus days duration of ovulatory cycle).\r\n* WOCBP are defined as those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopausal is defined as:\r\n** Amenorrhea >= consecutive months without another cause, or\r\n** For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > mIU/mL.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [hCG]) within days prior to registration; NOTE: women are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal; menopause is defined clinically as months of amenorrhea in a woman over in the absence of other biological or physiological causes. In addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for weeks after the last dose of study drugs; women of reproductive potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Patients who are pregnant or nursing; 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 must have a screening negative serum or urine pregnancy test within days of registration; a second pregnancy test must be done within hours prior to the start of the first cycle of study treatment; women must not be breastfeeding\r\n* 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 and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as month amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level greater than mIU/mL
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within hours prior to the start of study drug; a woman of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal; menopause is defined clinically as months of amenorrhea in a woman over age in the absence of other biologic or physiologic causes
Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= consecutive months without another cause or\r\n* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > mIU/mL
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within hours prior to receiving first dose of protocol-indicated treatment.\r\n* WOCBP is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.\r\n* Menopause is defined clinically as months of amenorrhea in a woman over years of age in the absence of other biological or physiological causes.\r\n* If menopausal status is considered for the purpose of evaluating childbearing potential, women < years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential.
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 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 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes. In addition, women under the age of must have a documented negative serum or urine test.
Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for weeks after the last dose of study drugs; women of reproductive potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for weeks after the last dose of study drugs; women of reproductive potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for days after the last dose of GC. This includes any woman who has experienced menarche but has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least consecutive months, or women on hormone replacement therapy with serum FSH levels greater than mIU/mL. A negative urine or serum pregnancy test must be obtained within days prior to the start of study therapy in all women of child-bearing potential.
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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug; WOCBP must have a negative serum pregnancy test within hours prior to enrollment and agree to use effective contraception throughout the treatment period and for months after the last dose of study treatment; 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
WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity iu/l or equivalent units of human chorionic gonadotropin [hcg]) within hours of the first dose of the study drug\r\n* \Women of childbearing potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes.
Patients who are pregnant or nursing; 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 must have a negative serum pregnancy test within days of study enrollment, prior to dosing nivolumab, then every weeks; after discontinuation from nivolumab these should be repeated at approximately days and approximately days; women must not be breastfeeding\r\n* 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 and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defiled clinically as month amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level greater than mlU/mL
Pregnant or lactating female: Women of childbearing potential (WOCB) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab; Women of childbearing potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes
Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration; 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 consecutive months of amenorrhea in a woman over in the absence of other biological or physiological causes; approved forms of birth control:\r\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\r\n* Progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)\r\n* Intrauterine device, intrauterine hormone-releasing system\r\n* Bilateral tubal occlusion/ligation\r\n* Vasectomized partner\r\n* Barrier contraception\r\n* Sexual abstinence
Women of childbearing potential (WOCBP) and male patients with WOCBP as partners must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to weeks after the last dose of the investigational agent; subject is practicing an acceptable method of contraception (documented in case report form [CRF]); WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= consecutive months without another cause or
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 consecutive months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL\r\n* WOCBP must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for weeks ( 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 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 % 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 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 (WOCBP) must have a negative serum or urine pregnancy test at screening; WOCBP must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for months after the last dose of investigational drug; women must not be breastfeeding; 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 months of amenorrhea in a woman over age in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
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 months of amenorrhea in a woman over in the absence of other biological or physiological causes
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 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 consecutive months, or women on hormone replacement therapy with serum follicle stimulating hormone [FSH] levels greater than mIU/mL); a negative urine or serum pregnancy test must be obtained within 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
WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level greater than mIU/mL
NOTE: Women of childbearing potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/ml
Of non-childbearing potential defined as women who have had a hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or are documented postmenopausal (follicle stimulating hormone > mIU/mL); OR, Of childbearing potential defined as including women < years of age, even those who have experienced years of amenorrhea; all women should also meet both of the following criteria:
Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for weeks after the last dose of study drugs; women of reproductive potential 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days prior to registration. These women must also have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab then every weeks thereafter. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are post-menopausal. Menopause is defined clinically as months of amenorrhea in a woman over in the absence of other biological or physiological causes. In addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL.
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 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that WOCBP use contraception for half-lives plus 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
Female participants of child bearing potential include any female who:\r\n* Has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) \r\n* Is not postmenopausal, defined as amenorrhea >= consecutive months\r\n* Is on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level > IU/mL
Patients who are pregnant or nursing; 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 weeks after the last dose of investigational drug; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity IV/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab; women must not be breastfeeding\r\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile or have undergone definitive radiation) 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 of bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as month amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level greater than mIU/mL\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product\r\n* Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform the treating physician immediately
Women who are pregnant or breastfeeding or adults of reproductive potential not employing an adequate method of contraception\r\n* Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
Patients who are pregnant or nursing; 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 weeks after the last dose of investigational drug; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity IV/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab or nivolumab + ipilimumab; women must not be breastfeeding; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception; women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as month amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level greater than mIU/mL; if, following initiation of the investigational product(s), it is subsequently discovered that a study subject is pregnant or may have been pregnant at the time of investigational product exposure, including during at least half-lives after product administration, the investigational product will be permanently discontinued in an appropriate manner (e.g., dose tapering if necessary for subject safety); the investigator must report this event and any outcomes by amendment through Cancer Therapy Evaluation Program (CTEP)-Adverse Event Reporting System (AERS); protocol-required procedures for study discontinuation and follow-up must be performed on the subject unless contraindicated by pregnancy (e.g., X-ray studies); other appropriate pregnancy follow-up procedures should be considered if indicated; in addition, the investigator must report and follow-up on information regarding the course of the pregnancy, including perinatal and neonatal outcome; infants should be followed for a minimum of weeks
Female subjects of childbearing potential defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or who is not postmenopausal (menopause being defined clinically as months of amenorrhea in a woman over in the absence of other biological or physiological causes) and male patients who are not surgically sterile (vasectomy etc.), must agree to use acceptable contraceptive methods for the duration of the study and for one month after the last vaccination; acceptable forms of contraception include oral contraceptives, intrauterine device, condom or vaginal diaphragm plus spermicidal (gel/foam/cream/vaginal suppository), or total abstinence
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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; additionally, women under the age of who are not surgically sterile must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL to document postmenopausal status\r\n* WOCBP must agree to use appropriate method(s) of contraception for months after the last dose of study treatment, per Food and Drug Administration (FDA) recommendations on use of contraception following bevacizumab; 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 (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 months of amenorrhea in a woman over in the absence of other biological or physiological causes
Pregnant and breastfeeding women are excluded. Women of child-bearing 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 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 consecutive months, or women on hormone replacement therapy with serum follicle stimulating hormone (FSH) levels greater than mIU/mL. A negative serum pregnancy test must be obtained within 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
Women must not be pregnant or nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to registration; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > mIU/mL)
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post-menopausal is defined as:\r\n * Amenorrhea >= consecutive months without another cause, or\r\n * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > mIU/mL
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for weeks ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; women who are not of childbearing potential are not required to use contraception
Women of childbearing potential must have a negative serum or urine pregnancy test within hours prior to the start of nivolumab\r\n* Women of childbearing potential 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\r\n* Menopause is defined as months of amenorrhea in a woman over in the absence of other biological or physiological causes; if menopausal status is considered for the purpose of evaluating childbearing potential, women under the age of must have a documented serum follicle stimulating hormone (FSH) level > mIU/mL, in order to be considered postmenopausal and not of childbearing potential
Pregnant and breastfeeding women are excluded; women of child-bearing 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 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 consecutive months), or women on hormone replacement therapy with serum follicle stimulating hormone (FSH) levels greater than mIU/mL; a negative urine or serum pregnancy test must be obtained within 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
Women of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal; postmenopausal is defined as:\r\n* Amenorrhea >= consecutive months without another cause OR\r\n* A documented serum follicle-stimulating hormone (FSH) level > mIU/mL (for women with irregular menstrual periods and on hormone replacement therapy)
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= mIU/mL
Women of child bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception; women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of weeks ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational product; a 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 consecutive months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL
Negative serum or urine pregnancy test done =< hours prior to randomization, for women of childbearing potential only; note: a 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) and is not postmenopausal; menopause is defined as months of amenorrhea in a woman over age years in the absence of other biological or physiological causes
Women of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least weeks following the last dose of study treatment ( half-lives of study drug plus days duration of ovulatory cycle)\r\n* WOCBP are defined as those who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post-menopausal is defined as:\r\n** Amenorrhea >= consecutive months without another cause, or\r\n** For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > mIU/mL
Women of child-bearing potential (WOCPB) 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 must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) at baseline; 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; NOTE: a 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes
Negative serum or urine pregnancy test done =< days prior to registration, for women of childbearing potential only;\r\n* Note: a woman of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal; menopause is defined as months of amenorrhea in a woman over age years in the absence of other biological or physiological causes
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 weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 % 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 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 months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than 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