[c09aa8]: / clusters / 9knumclustersv2 / clust_2814.txt

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Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for weeks after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
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 months after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 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 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 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 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 % per year; men receiving study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 % per year; men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 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 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 % per year for 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 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 % per year for 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 % per year; men who are receiving the study medications will be instructed to adhere to contraception for 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 months ( 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 % 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 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 who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 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 % per year
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than % per year; men who are receiving the study medications will be instructed to adhere to contraception for 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 % per year; men who are receiving the study medications will be instructed to adhere to contraception for weeks after the last dose of study drugs; men who are azoospermic do not require contraception
Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than % per year. Contraception should be continued for a period of days after the VTP procedure. The individual methods of contraception may be determined in consultation
Women of childbearing potential (WOCBP) and sexually active, non-sterile men must be willing to use acceptable method of contraception; WOCBP must agree to not get pregnant and sexually active, non-sterile men must agree not to impregnate a woman for at least weeks 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 % per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men who are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than hours, contraception should be continued for a period of days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to days and days, respectively. Therefore, men who are sexually active with WOCBP must continue contraception for months ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.
WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or barrier methods with a failure rate of less than % 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 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
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 % 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 days plus the time required for the investigational drug to undergo half-lives ( days).
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 months ( 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 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 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 % per year; Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 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 months ( 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 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 % per year; men receiving nivolumab will be instructed to use contraception for 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 months ( 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 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 % per year; men receiving nivolumab will be instructed to use contraception for 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 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 % per year
Negative serum or urine pregnancy test done =< 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 weeks ( 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 % per year; men receiving nivolumab and who are sexually active with POCBP will be instructed to adhere to contraception for a period of 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
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 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 weeks) after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 weeks ( 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 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that WOCBP use contraception for half-lives plus days and men who are sexually active with WOCBP use contraception for half-lives plus days
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for weeks after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that WOCBP use contraception for half-lives plus days and men who are sexually active with WOCBP use contraception for half-lives plus days
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab ( days) and are based on the protocol requirement that WOCBP use contraception for half-lives plus days and men who are sexually active with WOCBP use contraception for half-lives plus days
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 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 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 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 weeks ( 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 % per year; men who are receiving the study medications will be instructed to adhere to contraception for 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 % per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 use any contraceptive method with a failure rate of less than % per year the investigator shall review contraception methods and the time period that contraception must be followed; men who are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than hours, contraception should be continued for a period of days plus the time required for the investigational drug to undergo five half-lives; the half-life of nivolumab and ipilimumab is up to days and days, respectively; therefore, men who are sexually active with WOCBP must continue contraception for weeks ( days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
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 % 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 days plus the time required for the investigational drug to undergo half-lives ( days)
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
Men who are sexually active with women of child bearing potential must use adequate contraception upon study entry until 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 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 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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product
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 % per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of weeks after the last dose of investigational product; 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 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 % per year