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
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
Female participants must have a negative pregnancy test within 1 week of enrollment and all participants must agree to use two reliable methods of contraception simultaneously if conception is possible during the study and for 6 months after stopping treatment; should a woman subject become pregnant or suspect she is pregnant while the subject is participating in this study, she should inform her treating physician immediately; the participant will then be removed from protocol therapy; participants who father a child while participating in the study will be permitted to continue with the protocol; the participant, however, is required to notify the investigator if he fathers a child
Pregnancy test done within 14 days prior randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards; 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
Pregnant or breast feeding women; all patients (male and female) must agree to practice a medically acceptable method of contraception; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; 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
ELIGIBILITY CRITERIA - PHASE II (ARM D): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; 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
Men and women of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 30 days (for women) or 90 days (for men) after the last dose of study medication; 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
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
FCPB must have a negative urine or serum pregnancy test within 7 days prior to registration, and be willing to adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS®) program\r\n* NOTE: should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
The effects of nivolumab and ipilimumab on the developing human fetus are unknown; for this reason, women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol who are not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception from the time of signing consent, and for 31 weeks after their last dose of protocol-indicated treatment
Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Negative pregnancy test within 72 hours prior to the first dose of protocol therapy for women of childbearing potential. Must be willing to use effective contraception for 30 days before the first study drug administration, for the duration of trial participation and at least for 60 days after stopping trial participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician must be informed immediately.
Women of childbearing potential and men must agree to use contraceptive methods prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Women of childbearing potential must agree to use adequate contraception prior to study entry and through the precision breast IORT treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Sexually active women of childbearing potential and men must agree to use contraceptive methods, for the duration of study participation, and for 120 days after last dose of MK-3475; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
All men and women of childbearing potential must agree to use adequate barrier contraception for the duration of study participation and for 12 weeks after the last dose of study drug; should a woman become pregnant or suspect she is pregnant while participating in this study, she needs to inform her treating physician immediately
The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly-effective contraception prior to study entry, for the duration of study participation and up to 120 days after the last dose of the drug. 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
The effects of enzalutamide and CRLX101 on the developing human fetus are unknown. For this reason and because androgen receptor antagonists and topoisomerase I inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, all study subjects must agree to use a condom during the study treatment period and for 120 days following the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
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 must agree to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) prior to study entry, for the duration of study therapy and at least four months after the last treatment administration; should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately
Sexually active patients (male and female) must use medically acceptable methods of contraception during the course of the study and for 3 months after completion of study treatment; if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately; while on the study and for 3 months after final drug administration, women may not breast-feed
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued
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
Pregnancy and breast feeding are exclusion factors; enrolled patients must agree to use adequate contraception prior to study entry, the duration of study participation and 6 months after the end of the treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Pregnancy or breast feeding; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding must be discontinued if the mother is treated with pembrolizumab
Women of child-bearing potential should agree to use birth control while taking mebendazole if there is a reasonable risk of pregnancy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Sexually active women of childbearing potential and men must agree to use contraception methods, for the duration of study participation, and for 120 days after the last dose of pembrolizumab; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Sexually active women of childbearing potential must agree to contraceptive methods prior to study entry, for the duration of pre-operative study participation and until definitive hysterectomy/bilateral salpingo-oophorectomy; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
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
Males and females with reproductive potential must agree to use two forms of medically approved contraceptive precautions and for at least 6 months following the last dose of biochemoradiation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal; pregnant females will not be included in the study; males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued if the mother is treated in this study
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued
Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnancy or breast feeding; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding must be discontinued if the mother is treated with MK-3475
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months); 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; the potential hazard to the fetus should be explained to the patient and partner (as applicable)
Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice 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
Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); 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
RANDOMIZED PHASE II (ARMS K AND L): Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP); 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
Nursing and pregnant females; female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; negative urine pregnancy test (women of childbearing potential)
Documented negative serum beta human chorionic gonadotropin (HCG) for female patients who are post-menarchal; males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Women of child-bearing potential and male patients and their partners who are sexually active must agree to use two highly effective forms of contraception in combination for the duration of study participation and for 3 months after completion of olaparib and cediranib administration; 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
Women of childbearing potential and male patients should use effective contraception during treatment with MM-398 and for 90 days following the final dose of veliparib and MM-398 for both female and male patients; 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
Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Female patients who are pre-menopausal or have experienced menopause for less than 2 years must have a negative serum pregnancy test < 72 hours before starting study treatment. Male and female patients with reproductive potential must agree to use appropriate contraceptive methods while on study and for 3 months after the last dose of CPI-0610. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnancy: pregnant women are excluded from this study; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately; women who are pregnant or breastfeeding are excluded
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* Women of childbearing potential and men must agree to practice 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Women of childbearing potential and men must agree to use an accepted and effective method of contraception prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well
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; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post menopausal (amenorrheic for at least 12 months); 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
Pregnant or nursing women. NOTE: If a woman became pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.
Female subjects who are pregnant or breast-feeding are not eligible; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; likewise, should a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study, he should inform his treating physician and the female partner should call her physician immediately
Women of child-bearing potential must have a negative serum pregnancy test within 14 days of study entry; 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
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 men must agree to use adequate contraception six months after study entry; women of childbearing age who are sexually active and could possibly be pregnant will have a negative serum or urine beta human chorionic gonadotropin (bHCG) within seven days of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Women of childbearing potential 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; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Women of child-bearing potential must agree to avoid becoming pregnant and men must agree not to father a child for the duration of the study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, or should a man father a child, she/he should inform her/his treating physician immediately
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Nursing or pregnant females; should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately
Women of child-bearing potential must agree to use highly effective contraception prior to study entry and for at least 2 weeks after the last dose of ivabradine; 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
Pregnant women; women of child-bearing potential should be using two forms of birth control while on the study; should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately
Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnant or lactating women; breastfeeding should be discontinued if the mother is treated with aspirin; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
RECIPIENT: Agreement by females of childbearing potential and males with partners of childbearing potential to use effective contraception (hormonal or barrier method or abstinence) prior to study entry and for up to 90 days post?HCT. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued
Participant must have a negative urine pregnancy test 14 days prior to randomization or drug administration; women of childbearing potential must agree to use adequate contraception from time of drug administration to time of surgery; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Must agree to use medically acceptable barrier and/or chemical method of contraception while on study and for at least one month following the last vaccine injection; should a participant's partner become pregnant or suspect she is pregnant while the participant is participating in this study, the study physician should be informed immediately; in the event a participant’s partner becomes pregnant, the study sponsor may request additional information regarding the course of the pregnancy and if the pregnancy is carried to term, the birth of the child (i.e., the outcome of the pregnancy)
Pregnant or breast feeding women are excluded; all patients (male and female) must agree to practice a medically acceptable method of contraception; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
Pregnant or lactating women; breastfeeding should be discontinued if the mother is treated with aspirin; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Pregnant or lactating women; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a negative pregnancy test will be required for all female subjects with child bearing potential