Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.
Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least  days after the last dose of either ipilimumab or IMO-, whichever is later.
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
Male subject and woman of child-bearing potential (WOCBP) must agree to use a medically-effective, double-barrier method of contraception (as defined in the ICF) to prevent pregnancy while on study and for  months after the last dose of IMP. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea ?  consecutive months without an alternative medical cause). If the subject is a WOCBP, she must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Cycle  Day  (monotherapy run-in period; prior to receiving KHK);
The effects of nivolumab and ipilimumab on the developing human fetus are unknown; for this reason, women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception from the time of signing consent, and for  weeks after their last dose of protocol-indicated 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; men treated or enrolled on this protocol who are not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception from the time of signing consent, and for  weeks after their last dose of protocol-indicated treatment
Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception; WOCBP should plan to use an adequate method to avoid pregnancy for  months ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
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 and for  months after the last dose of nivolumab; 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; sexually active fertile men must use effective barrier birth control if their partners are WOCBP for  months after the last dose of nivolumab; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity  IU/L or equivalent units of human chorionic gonadotropin [HCG]) within two weeks of registration
WOCBP and men with female partners (WOCBP) that are not willing to use contraception
Women of childbearing potential (WOCBP) must agree to 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 woman or adolescent who has begun menstruation and is not post-menopausal; a post-menopausal woman is defined as a woman who is over the age of  and has not had a menstrual period for at least  months
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; women of child bearing potential (WOCBP) or male study participants of reproductive potential must agree to use double barrier birth control method of contraception during the course of the study treatment period and for  months after completing study treatment; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenopausal (no menses) for at least  consecutive months; WOCBP must have a negative urine or serum pregnancy test within  days prior to administration of treatment
Women who are pregnant or lactating, or intending to become pregnant before, during, or within  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 of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception as stated for the timeline below
WOCBP and male partners of WOCBP must agree to use two methods of contraception until at least  months after last dose of each study drug for WOCBP subjects, and  months for male partners of WOCBP
Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day  through at least  days after the last dose of study drug.
Women of child-bearing potential (WOCBP) and men able to father a child must agree to use highly effective contraception (any contraceptive method with a failure rate of less than  percent [%] per year) while on study drug and for  weeks (for women) or  weeks (for men) after the last dose of study drug\r\n* WOCBP must have a negative serum or urine pregnancy test within  hours of initiation of study drug\r\n* 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 to be defined as post-menopausal\r\n* WOCBP receiving nivolumab 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 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 and men who are sexually active with WOCBP use contraception for  half-lives plus  days\r\n* Highly effective contraceptive measures include: stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for  or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomy and sexual abstinence\r\n* Contraception is not required for men with documented vasectomy\r\n* Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation \r\n* Women must not be breastfeeding
Women who are pregnant or lactating, or intending to become pregnant before, during, or within  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.
Childbearing potential and agrees to use method(s) of contraception. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than % per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. Women of childbearing potential (WOCBP) must follow instructions for birth control when the half-life of the investigational drug is greater than  hours, contraception should be continued for a period of  days plus the time required for the investigational drug to undergo five half-lives. WOCBP should use an adequate method to avoid pregnancy for  months ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
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.
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for  months ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for  months ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day  through at least  days after the last dose of study drug.
Women of childbearing potential (WOCBP) must use highly effective method(s) of contraception; WOCBP should use a highly effective method to avoid pregnancy for the duration of this study and for at least  months after the last dose of nivolumab; WOCBP and men must agree to use a highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least  months from the last dose of nivolumab; 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 who are sexually active with WOCBP must also use a highly effective contraceptive method for at least  months after the last dose of nivolumab
Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for  weeks after discontinuation of study drug.
Women of childbearing potential (WOCBP) must practice  effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception: postmenopausal women must be amenorrheic for >=  months to be considered of non-childbearing potential; women and men must continue birth control for the duration of the trial and >=  months after the last dose of study drug; all WOCBP MUST have a negative pregnancy test prior to first receiving study medication(s)
Women of child-bearing potential (WOCBP):\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n** Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)\r\n* WOCBP must have a negative serum or urine pregnancy test at screening and within  hours prior to the start of investigational product\r\n* Women must not be breastfeeding\r\n* WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and contraception should be continued for a period of  days plus the time required for the investigational drug to undergo five half-lives; this is equivalent to  weeks after discontinuation of nivolumab\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; contraception should be continued for a period of  days plus the time required for the investigational drug to undergo five half-lives; this is equivalent to  weeks after discontinuation of nivolumab
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration described below\r\n* WOCBP must use agree to use contraception until  half-lives plus  days following last study intervention ( weeks after last dose of nivolumab)\r\n* Male subjects who are sexually active with WOCBP must agree to use adequate contraception until  half-lives plus  days following last study intervention ( weeks after last dose of nivolumab)
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 study drug
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 and for up to  weeks after the last dose of nivolumab; 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; sexually active fertile men must use effective barrier birth control if their partners are WOCBP for up to  weeks after the last dose of nivolumab; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity  IU/L or equivalent units of human chorionic gonadotropin [HCG]) within two weeks of registration; women must not be breastfeeding
Men with female partners (WOCBP) that are not willing to use contraception
Men and 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 up to  months after the study. Subjects who are men must also agree to use effective contraception. Note: WOCBP must be using an adequate method of contraception throughout the study and for up to  months after the study. Adequate methods of contraception will include (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Women who are pregnant or lactating, or intending to become pregnant before, during, or within  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.
WOCBP must be using highly effective and medically accepted method of contraception to avoid pregnancy throughout the study and for at least  months after the study ; . WOCBP must have a negative serum or urine pregnancy test within  hours prior to the start of study drug.
Female subjects: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female subject is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <% per year), preferably with low user dependency, during the intervention period and for at least  days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within  hours before the first dose of study intervention.
The contraception's used by female subject's be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <% per year), preferably with low user dependency, during the intervention period and for at least  days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. WOCBP must have  negative highly sensitive serum pregnancy tests, as required by local regulations (first within  days of Cycle  Day  and the second one within  hours of dosing on Cycle Day) and agree to use effective contraception during the study and for  days after the last dose of study medication; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product; sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; all WOCBP should be instructed to contact the investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
The individual methods of contraception and duration should be determined in consultation with the investigator; women of childbearing potential (WOCBP) must follow instructions for birth control when the half-life of the investigational drug is greater than  hours, contraception should be continued for a period of  days plus the time required for the investigational drug to undergo five half-lives; the half-life of nivolumab and ipilimumab is up to  days and  days, respectively; 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 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 investigational product
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
Women of childbearing potential (WOCBP) and men who are sexually active, even if surgically sterilized, with WOCBP must agree to use effective methods of contraception during active treatment, for the duration of the study, and for  months after the completion of the study
WOCBP using a prohibited contraceptive method
Men and women agreement to use effective contraceptive method. For WOCBP and for men, agreement to use an effective contraceptive method from the time of screening throughout the study until  month for WOCBP or  months for men after administration of the last dose of any study medication.
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
WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least  month prior to study entry, for the duration of the study, and for at least  months after the last dose of study medication.
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
Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Women of childbearing potential (WOCBP) must not be pregnant
Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
WOCBP and male subjects who are sexually active with WOCBP must agree to use  highly effective methods of contraception (including a physical barrier) before the first dose of study drugs, during the study, and for  months for women and  months for men following the last dose of study drug.