Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
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
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
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 should be willing and able to use medically acceptable forms of contraception during the trial
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
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
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
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
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
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
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 who are sexually active and not willing/able to use medically acceptable forms of 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
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
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
Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of 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
Patients who are sexually active must 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
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
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
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, women who cannot discontinue breastfeeding 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
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
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
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 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 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
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.
Pregnant women or sexually active patients not willing or able to use medically acceptable forms of contraceptive method while on treatment.
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
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
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 a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment
Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
Patients who are sexually active and not willing/able to use medically acceptable forms of barrier 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
Patient must not be pregnant or breastfeeding; if a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception
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
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 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
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
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
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.
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 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
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 men who are sexually active and not willing/able to use medically acceptable forms of contraception
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother receives ferumoxytol while nursing; men who are sexually active and not willing/able to use medically acceptable forms of contraception are also excluded from this study
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 be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping midostaurin medication; they should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Female patients must agree not to breastfeed their infants while on study; patients of child fathering potential (defined as > Tanner stage 2) must use a condom during intercourse while taking the drug during treatment, for 8 weeks after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men during intercourse with a male or female partner in order to prevent delivery of the study drug via semen
Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 150 days after stopping the study drug and should not father a child in this period; a condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; Note: A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking the drug and for 4 months after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males, unless they use a condom during intercourse while taking the drug, and for 21 days after stopping treatment of LEE011 -- should not father a child in this period; a condom is required to be used also by vasectomized male in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; fertile males must use a condom with spermicide (double barrier method)
Male Contraception\r\n* During the course of the clinical trial, sexually active males must use a condom during intercourse while taking the drug and should not father a child in this period and for up to 8 weeks after stopping treatment\r\n* A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid\r\n* Female partners of male patients must also be advised to use one of the following contraception methods: use of (1) oral, injected, implanted or other hormonal methods of contraception, or (2) intrauterine device (IUD) or intrauterine system (IUS), or (3) prior male/female sterilization
Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking drug and for 7 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; for males with female partners of childbearing potential, couples must use highly effective means of contraception while taking the study drug
Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping study drug and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking the drug(s) and for 120 days after stopping study treatment and should not father a child in this period
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of study treatment; male patients for 3 months should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 21 days after completion of study medication; this includes condom use: a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while receiving chemoradiation and for 90 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
PART 2 GROUP 1 EXCLUSION CRITERIA: Sexually active males unless they use a condom during intercourse while on protocol therapy and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period
PART 2 GROUP 2A EXCLUSION CRITERIA: Sexually active males unless they use a condom during intercourse while on protocol therapy and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period
PART 2 GROUP 3 EXCLUSION CRITERIA: Sexually active males unless they use a condom during intercourse while on protocol therapy and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period
Sexually active males must agree to use a condom during intercourse while receiving and for 3 months after the last dose of study treatment; male patients should not father a child for 3 months after the last dose of study treatment; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking drug and for three months after the last dose of the study drug; they should not father a child during this period; men who have undergone vasectomy are also required to use a condom during intercourse
Sexually active males unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
CAPMATINIB EXCLUSION CRITERIA: Sexually active males unless:\r\n* A condom is used during intercourse while taking drug and 7 days after the last dose of entrectinib; male patients should not father a child in the 7 days after the last dose of the study treatment\r\n* Male sterilization has taken place, with appropriate postvasectomy documentation of the absence of sperm in the ejaculate; condom use is also required in vasectomized men in order to prevent delivery of the drug via seminal fluid
CERITINIB EXCLUSION CRITERIA: Sexually active males unless:\r\n* A condom is used during intercourse while taking drug and 7 days after the last dose of entrectinib; male patients should not father a child in the 7 days after the last dose of the study treatment\r\n* Male sterilization has taken place, with appropriate postvasectomy documentation of the absence of sperm in the ejaculate; condom use is also required in vasectomized men in order to prevent delivery of the drug via seminal fluid
REGORAFENIB EXCLUSION CRITERIA: Sexually active males unless:\r\n* A condom is used during intercourse while taking drug and for 3 months after the last dose of entrectinib; male patients should not father a child in the 3 months after the last dose of the study treatment\r\n* Male sterilization has taken place, with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate; condom use is also required in vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they agree to use a condom during intercourse while taking drug and agree to continue for 3 months after the last dose of study treatment; male patients for 3 months should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse
Sexually active males unless they use a condom during intercourse while taking drug and for 31 weeks after the last dose of study treatment.
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of study treatment; male patients for 3 months should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; also male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception during the study and for 3 months after the end of enrollment
Sexually active males unless they agree to use a condom during intercourse while taking drug and agree to continue for 3 months after the last dose of study treatment; male patients for 3 months should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males who are unwilling to use a condom during intercourse while taking drug and for 6 months after stopping investigational medications and agree not to father a child in this period
Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping study drug and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 4 weeks after stopping treatment
Sexually active males unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
Sexually active males unless they are willing to use a condom during intercourse while taking the drug and for 15 days after stopping treatment and are willing to forego fathering a child in this period; a condom is required to be used also by vasectomized men
Sexually active men must use a condom during intercourse while taking study drug and for 60 days after study drug discontinuation; a condom is required for vasectomized men to prevent delivery of study drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males should use a condom during intercourse while taking drug and for 8 weeks after the final dose of study treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping study drug and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males, unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment; they should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking the drugs and for 16 weeks after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males unless they use a condom during intercourse while taking drug and for 5 months after stopping midostaurin medication; they should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unwilling to use a condom during intercourse while taking drug and for 45 days after stopping investigational medication. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Male patients should not father a child in this period.
Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study (and for up to 12 weeks after the last dose of study drug) to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Patients who are not willing to apply highly effective contraception during the study and through the duration of LDE225 treatment\r\n* Male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the last dose of the study drug; a condom is also required to be used by vasectomized men as well as during intercourse with a male partner; sexually active males must be willing to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child during this period
Sexually active males unless they use a condom during intercourse while taking the drug and for 60 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Sexually active males, who do not agree to abstinence, must be willing to use a condom during intercourse while taking the study drug, and for 16 weeks after stopping treatment and should not father a child in this period.
Sexually active males must use a condom during intercourse while taking the drug for 6 months after stopping treatment and should not father a child in this period; a condom is required to be use also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males must use a condom during intercourse while taking the drug and for 90 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse during and for 3 months after the last dose of the study treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Sexually active males unless they use a condom during intercourse while taking the drug and for 8 weeks after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Fertile males not willing to use contraception; fertile males must use condom with spermicide; highly effective contraception, as defined above, must be used by both sexes (male patients and their female partners) during study treatment and for 90 days after the last dose of study medication and should not father a child in this period; a condom is required to be used also by vasectomized men
Male patient must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continue using contraception and refrain from fathering a child for 6 months following the study drug; a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid
Sexually active males who are unwilling to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child in this period
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
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 31 weeks after the last dose of investigational product
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
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving study drug 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
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
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
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
Men able to father children who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception from the time of signing consent and until 6 months after last dose of study therapy; men able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy)
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)
Men not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception, from the time of signing consent, and for 31 weeks after their last dose of protocol-indicated 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.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year
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.
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 1 percent [%] per year) while on study drug and for 23 weeks (for women) or 31 weeks (for men) after the last dose of study drug\r\n* WOCBP must have a negative serum or urine pregnancy test within 24 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 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 to be defined as post-menopausal\r\n* WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 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 and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 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 2 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
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
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 (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 not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.
Men able to father children who are sexually active with WOCBP must agree to use at least 2 methods of acceptable contraception from the time of signing consent and until 2 months after patient’s last dose of protocol-indicated treatment; men able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy)
WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year, or abstinence) prior to study entry and throughout study drug administration; WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 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 who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control for a period of 90 days plus the time required for the investigational drug to undergo 5 half-lives (60 days).
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) 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
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
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
Men who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year
Negative serum or urine pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only\r\n* Note: persons of child-bearing potential (POCBP) must use appropriate method(s) of contraception; POCBP 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 POCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with POCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; persons 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 person become pregnant or suspect being pregnant while participating in this study, the person should inform the treating physician immediately
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
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 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 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
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) 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; 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 and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days
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 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
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 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 and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days
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) receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 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 and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days
Men who are sexually active with WOCBP must use acceptable birth control methods; acceptable birth control methods include: oral or injectable hormonal birth control, intrauterine devices (IUDS), and double barrier methods (for example a condom in combination with spermicide); 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 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
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
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.
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 who are not of childbearing potential (i.e., who 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; the investigator shall review contraception methods and the time period that contraception must be followed; men that are sexually active with WOCBP must follow instructions for birth control for a period of 90 days plus the time required for the investigational drug to undergo 5 half-lives (60 days)
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 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 31 weeks after the last dose of investigational product
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
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
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate if 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 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
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; men who are sexually active with WOCBP must use a contraceptive method with a failure rate of less than 1% per year
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
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
Sexually active males and pre/perimenopausal women must agree to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy
Women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for at least 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 7 months after the last dose of nivolumab and/or ipilimumab; 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) and males who are sexually active with WOCBP must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with WOCBP
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with WOCBP
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment
Sexually active males must use an accepted and effective method of double barrier contraception or abstain from sexual intercourse for the duration of their participation in the study and for 26 weeks after the last dose of study drug
Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study; WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug; sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months post rituximab treatment
Women of childbearing potential and sexually active males must be strongly advised to use accepted and effective methods of contraception, as described in the informed consent form (ICF), or to abstain from sexual intercourse for the duration of their participation in the study; women of childbearing potential should use adequate methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually active males should use adequate methods to avoid pregnancy for 31 weeks after the last dose of nivolumab
In sexually active patients (women of childbearing potential and males), willingness to use 2 effective methods of contraception, of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
Patients must not be pregnant or breastfeeding; sexually active patients are strongly advised to use accepted, effective forms of contraception
Sexually active patients of childbearing potential must agree to use effective contraception
Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 6 months after last administration of study treatment.
Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study (Appendix C:Guidelines Regarding Women of Childbearing Potential).
Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed
Sexually active males unwilling to practice contraception during the study and 6 months beyond
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant; women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment and negative serum or urine ?-hCG\r\npregnancy test at screening for patients of childbearing potential
Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
Women of child-bearing potential must use at least two accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 4 months (120 days) after the last dose of nivolumab and/or ipilimumab; sexually active males must also use at least two accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 4 months (120 days) after the last dose of nivolumab and/or ipilimumab
Women of child bearing potential and sexually active males must use an accepted and effective non-hormonal method of contraception
PART 2 GROUP 1 INCLUSION CRITERIA: Males and females who are sexually active must agree to use effective contraception during and for three months after treatment
PART 2 GROUP 2A INCLUSION CRITERIA: Males and females who are sexually active must agree to use effective contraception during and for three months after treatment
PART 2 GROUP 3 INCLUSION CRITERIA: Males and females who are sexually active must agree to use effective contraception during and for three months after treatment
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Sexually active patients of childbearing potential must agree to use effective contraception
Agreement by females of childbearing potential and sexually active males to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test < 2 weeks prior to registration
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator
Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 6 months after last administration of 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 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
REGISTRATION TO TREATMENT (STEP 1): Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment
REGISTRATION TO TREATMENT (STEP 2): Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sex from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment
ENROLLMENT: Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized).
Sexually active males must be strongly advised to use an accepted and effective method of contraception
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for at least one week prior to the start of the research study, and continuing for 5 months for women of childbearing potential and 7 months for sexually active males after the last dose of the study drugs
Women of childbearing potential and sexually active males must use an accepted and\n             effective method of contraception throughout the study and for 8 weeks after\n             completion of the study.
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
PHASE II: Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy
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
Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or agree to abstain from sexual intercourse during their participation in the study and for 3 months following completion of their participation
Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception
Women of childbearing potential and sexually active males must agree to practice abstinence or use an accepted and effective method of contraception
Males (if sexually active with a FCBP) must
Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Sexually active patients of childbearing potential must agree to use effective contraception
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for 90 days after the last dose of study drug
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Females of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception while on study
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 and sexually active males 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 or IUDs (these may include low-dose hormones at the discretion of the Study Chair)
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Women of childbearing potential and sexually active males must be strongly advised to use an accepted method of contraception
Women of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study and for 30 days following the last dose;
Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 30 days after last administration of study treatment
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed
Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Sexually active fertile subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 30 days after the last dose of study treatment
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 months after termination of study therapy
Male and female subjects must agree to medically accepted methods of contraception
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Sexually active fertile subjects (male and female), and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s)
Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
Sexually active participants and their partners must agree to use medically accepted methods of contraception
Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
If a sexually active male or a sexually active female of child-bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose of either ONT-10 or T-DM1, whichever is longer.
Sexually active fertile patients (male and female), and their partners, must agree to use medically accepted methods of contraception during the course of the study and for 3 months after the last dose of the study drug
Female subjects who are lactating, pregnant or both male and female subjects with reproductive potential who refuse to practice medically accepted methods for contraception over the period from study consent to 90 days following the last dose of study treatment
Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s)
Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s) for Cohorts 1, 2, and 4, and for 3 months after the surgery for Cohort 3
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
Sexually active participants must use medically acceptable methods of contraception during the course of this study
Sexually active subject (male and female) must use medically acceptable methods of contraception during the course of the study
Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study
Females of childbearing potential who are sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; female patients should also refrain from breastfeeding throughout this period
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; male patients should refrain from sperm donation throughout this period
Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product\r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days 1 through 90 post last dose; in addition, they must refrain from sperm donation for 90 days after the final dose of investigational product
Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of investigational product; male partners of a female subject must also agree to use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; female patients should refrain from breastfeeding throughout this period; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as >= 12 months with no menses without an alternative medical cause)
Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use male condom plus spermicide from screening through 180 days after the last dose of investigational product; not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not\r\nacceptable methods of contraception; male patients should refrain from sperm donation throughout this period; female partners of a male subject must use a highly effective method of contraception throughout this period
Females of childbearing potential who are sexually active with a nonsterilized male partner agree to use 2 methods of effective contraception from screening, and agree to continue using such precautions for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
Nonsterilized males who are sexually active with a female of childbearing potential must agree to use an acceptable method of effective contraception from Day 1 and for 90 days after the final dose of study drug.
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized male subjects who are sexually active with a female partner of childbearing potential must be willing to use 2 methods of effective contraception from time of screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy, whichever is the longer time period
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); a highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system-Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch)
Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; female subjects must also refrain from egg cell donation for 180 days after the final dose of investigational product\r\n* Females of childbearing potential are defined as those who are not surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses with postmenopausal gonadotropin levels [luteinizing hormone and follicle-stimulating hormone], or estradiol levels within the postmenopausal range according to local guidelines without an alternative medical cause)\r\n** A highly effective method of contraception is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly
All men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below:\r\n* Females of childbearing potential: Recommendation is for at least one highly effective contraceptive methods during the study and must agree to continue using such precautions for 180 days after the last dose of investigational product\r\n* Non-sterilized males: Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use male condom plus spermicide from screening through 180 days after the last dose of investigational product
Female subjects must not be pregnant, or breast feeding and must have a negative urine or serum pregnancy test within 28 days prior to treatment on day 1; females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 90 days after the final dose of durvalumab; they must also refrain from egg cell donation for 90 days after the final dose of durvalumab
Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception and refrain from sperm donation from day 1 through 90 days after receipt of the final dose of durvalumab
Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product
Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product
Nonsterilized males who are sexually active with a female partner of childbearing potential must agree to use a highly effective method of contraception from day 1 through 90 days after receipt of the final dose of investigational product; in addition, they must refrain from sperm donation for 90 days after the final dose of investigational product
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician
Females of childbearing potential must also refrain from egg cell donation for 180 days after the final dose of investigational product; \r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgesterl-releasing intrauterine system - Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch); non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days 1-180 post last dose; in addition, they must refrain from sperm donation for 180 days after the final dose of investigational product
Male patients who are sexually active with a female partner of childbearing potential must be either surgically sterilized or agree to use barrier contraception (ie, condoms) for the duration of study participation, and for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician
Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of MEDI4736 and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of MEDI4736 and tremelimumab\r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not post-menopausal (defined as 12 months with no menses with postmenopausal gonadotropin levels, luteinizing hormone [LH] and follicle-stimulating [FSH], or postmenopausal estradiol levels within the postmenopausal range according to local guidelines without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, Copper T intrauterine device, levonorgestrel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception (as outlined above) from day 1 through 90 days after receipt of the final dose of MEDI4736 and tremelimumab; in addition, they must refrain from sperm donation for 90 days after the final dose of investigational product
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control\r\n* Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* Subjects must use 2 acceptable methods of effective contraception
Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from day 1 and for 90 days after receipt of the final dose of investigational product
Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception from screening throughout study treatment, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include the following:
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception.
Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of durvalumab and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; they must also refrain\r\nfrom egg cell donation for 180 days after the final dose of durvalumab and tremelimumab\r\n* Note: A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, copper T intrauterine device, levonorgesterel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)
Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions for at least 90 days after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control
Nonsterilized males who are sexually active with a female partner of child-bearing potential must use a highly effective method of contraception from day 1 through 90 days after receipt of the final dose of investigational product
Nonsterilized males who are sexually active with a female partner of childbearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of study medication.
Females of childbearing potential who are sexually active with a non-sterilized male partner and non-sterilized males must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 180 days after the final dose of investigational product; females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); a highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly; the acceptable methods of contraception are: barrier method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system - Mirena) or hormonal methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch)
Females of childbearing potential who are sexually active with a non-sterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause); non-sterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from day 1 and for 31 weeks after receipt of the final dose of investigational product; acceptable methods of effective contraception are described in the following table: \r\n* Barrier methods: male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide\r\n* Intrauterine device methods: copper T, levonorgestrel-releasing intrauterine system (e.g. Mirena), also considered a hormonal method\r\n* Hormonal methods: implants, hormone shot or injection, combined pill, min ipilimumab ll, or patch
Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of investigational product; the male partner of a female subject must also use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; female patients should refrain from breastfeeding and egg cell donation throughout this period\r\n* Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly
Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use male condom plus spermicide from screening through 180 days after the last dose of investigational product; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; male patients should refrain from sperm donation throughout this period; female partners of a male subject must use an effective method of contraception throughout this period
Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; they must also refrain from egg cell donation for 6 months after the final dose of investigational product\r\n* Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days 1 through 90 post last dose; in addition, they must refrain from sperm donation for 90 days after the final dose of investigational product
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of highly effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; 10) Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 6 months after receipt of the final dose of investigational product.
Female patients of reproductive potential, defined as not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal (see above for definition) and non-sterilized males who are sexually active with a female partner of reproductive potential must be willing to adhere to the following restrictions:\r\n* Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; it is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice\r\n* Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; not engaging in sexual activity is an acceptable practice; male patients should refrain from sperm donation throughout this period; it is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period\r\n* Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly\r\n** Barrier/intrauterine methods\r\n*** Copper T intrauterine device\r\n*** Levonorgestrel -releasing intrauterine system (e.g., Mirena); this is also considered a hormonal method\r\n** Hormonal methods\r\n*** Implants: etonogestrel-releasing implants: e.g. Implanon or Norplant\r\n*** Intravaginal: ethinylestradiol/etonogestrel releasing intravaginal devices: e.g. NuvaRing\r\n*** Injection: medroxyprogesterone injection: e.g. Depo-Provera\r\n*** Combined pill: normal and low dose combined oral contraceptive pill\r\n*** Patch: norelgestromin/ethinylestradiol releasing transdermal system: e.g. Ortho Evra\r\n*** Minipill: progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening and must agree to continue using such precautions for at least 180 days after the last dose of investigational product. Depending on the investigational product received, this period may be longer. Cessation of birth control after this point should be discussed with a responsible physician
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception (Table 4.2.1-1) from at least Day 1 through 90 days after the last dose of investigational product
Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of KTN3379.
Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from 7 days post-screening, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.
Female patients of reproductive potential and non-sterilized males who are sexually active with a female partner of childbearing potential must be willing to adhere to the following restrictions:\r\n* Females of reproductive potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening until 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; it is strongly recommended that non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice\r\n* Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; not engaging in sexual activity is an acceptable practice; male patients should refrain from sperm donation throughout this period; it is strongly recommended that female partners (of childbearing potential) of male patients to also use a highly effective method of contraception throughout this period \r\n* Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly \r\n** Barrier/Intrauterine methods \r\n*** Copper T intrauterine device\r\n*** Levonorgestrel-releasing intrauterine system (e.g., Mirena)\r\n** Hormonal Methods\r\n*** Implants: Etonogestrel-releasing implants (e.g. Implanon or Norplant)\r\n*** Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g. NuvaRing\r\n*** Injection: Medroxyprogesterone injection: e.g. Depo-Provera\r\n*** Combined pill: Normal and low dose combined oral contraceptive pill\r\n*** Patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g. Ortho Evra \r\n*** Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.
Agreement to use acceptable methods of contraception during the study and for at least 120 days after the last dose of APX3330 if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Agreement to use contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear children.
Agreement to use acceptable methods of contraception during the study and for ? 120 days after the last dose of PNT2258 if sexually active and able to bear or beget children.
Lactating or pregnant or will not agree to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children