Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 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
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days through post last dose; in addition, they must refrain from sperm donation for days after the final dose of investigational product
Nonsterilized males who are sexually active with a female of childbearing potential must agree to use an acceptable method of effective contraception from Day and for 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 methods of effective contraception from time of screening through days after receipt of the final dose of durvalumab + tremelimumab combination therapy or days after receipt of the final dose of durvalumab monotherapy, whichever is the longer time period
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 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 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 days prior to treatment on day ; 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 days after the final dose of durvalumab; they must also refrain from egg cell donation for 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 through 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 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 through days after receipt of the final dose of investigational product; in addition, they must refrain from sperm donation for days after the final dose of investigational product
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 through days after receipt of the final dose of MEDI and tremelimumab; in addition, they must refrain from sperm donation for days after the final dose of investigational product
Nonsterilized males who are sexually active with a female partner of childbearing potential must use acceptable methods of effective contraception from day and for days after receipt of the final dose of investigational product
A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:
Sexually active with female partner only
Females of childbearing potential who are sexually active with a nonsterilized male partner must use methods of effective contraception.
Nonsterilized males who are sexually active with a female partner of child-bearing potential must use a highly effective method of contraception from day through 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 acceptable methods of effective contraception from Day through days after receipt of the final dose of study medication.
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from days through post last dose; in addition, they must refrain from sperm donation for days after the final dose of investigational product
Females of childbearing potential who are sexually active with a nonsterilized male partner must use methods of highly effective contraception from screening, and must agree to continue using such precautions for days after the final dose of investigational product; ) Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day through days after receipt of the final dose of investigational product
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception (Table ..-) from at least Day through days after the last dose of investigational product
A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:
Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use acceptable methods of effective contraception from Day through days after receipt of the final dose of KTN.
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 days post-screening, and must agree to continue using such precautions for 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 days post-screening and for days after receipt of the last dose of investigational product.