[c09aa8]: / clusters / 9knumclustersv2 / clust_1248.txt

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Female partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period
Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners if of childbearing potential must use a highly effective method of contraception (see methods described in Inclusion Criterion #) beginning at least menstrual cycle prior to starting study drug(s), throughout the entire study period, and for days after the last dose of study drug, unless the male participants are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile.
Male participants with partners of childbearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within months of the last dose of study drug are excluded.
Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least days after the last dose of chemotherapy or at least days after the last dose of avelumab, whichever is longer.
Male subjects with female partners of childbearing potential must agree to use an adequate method of contraception for weeks prior to screening, during, and at least weeks after last dose of trial medication.
Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.
Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners from enrollment through days after the end of treatment
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use adequate methods of contraception as defined by protocol during the course of this study and for at least months after completion of study treatment
Male participants whose partners are pregnant should use condoms for the duration of the pregnancy
Non-sterile male patients who are sexually active with female partners of childbearing potential must agree to follow instructions for acceptable or highly effective method(s) of contraception for the duration of study treatment and for months after the last dose of study treatment with nivolumab
Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least days after the last dose of assigned treatment; a patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active
Non-sterilized male subjects 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; 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
Required that female patients of childbearing potential use two methods of contraception with their partner
Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception.
Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day and continuing until at least four weeks after administration of the subject's final dose of RRx-.
Male w/partner(s) (childbearing) unwilling to use contraception
Female patients of childbearing potential must have a negative serum pregnancy test within days prior to taking their first dose of BGB. Male patients and female patients of reproductive potential must practice highly methods of contraception throughout the study and for ? months after the last dose of BGB.
Female patients of childbearing potential and sexually active males and female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least days after the last dose of assigned treatment
Male patients must use a condom during treatment and for months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking olaparib and for months following the last dose of olaparib
For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for months after discontinuation of vemurafenib
Pregnant female patients; breastfeeding female patients; and female patients of childbearing potential who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for days.
Women of childbearing potential must have a negative serum pregnancy test within hours prior to the first dose of study treatment and agree to use appropriate highly effective methods of contraception, during the study and for months following completion of study treatment;\r\n* A woman of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as months of amenorrhea in a woman over in the absence of other biological or physiological causes; in addition, women under the age of must have a documented serum follicle stimulating hormone (FSH) level less than mIU/mL\r\n* Female subjects: women of child bearing potential are expected to use one of the highly effective methods of contraception\r\n* Male subjects: male subjects must inform their female partners who are women of child bearing potential of the contraceptive requirements and are expected to adhere to using contraception with their partner; female partners of male subjects, who are women of child bearing potential, are expected to use one of the highly effective methods of contraception; in addition, male subjects are expected to use a condom
Negative serum pregnancy test in women of childbearing potential within days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during and after days post dose. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices.
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Male patients with female partners of childbearing potential and female patients of childbearing potential must agree to use contraception for six months after receiving the preparative regimen
Female patients of childbearing potential and male patients who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation and for months ( half-lives of Lu-) after the last dose of Lu--DOTATATE
Women of childbearing potential must have a negative serum pregnancy test performed within days prior to enrollment. Within the frame of this study, female patients of childbearing potential and male patients with partners of childbearing potential must use an effective method of birth control, as described below, as well as their partners. Patients enrolled in the Dose Finding Portion of the Study:
Male patients must use a condom during treatment and for months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
Female patients of childbearing potential must agree to use methods of contraception (including highly effective and effective method of contraception) and have a negative serum pregnancy test at screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for months following the last dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception throughout the study and for months after their last dose of medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility (including hysterectomy and/or bilateral oophorectomy, but not tubal ligation alone) or evidence of post-menopausal status defined as any of the following:\r\n* Natural menopause with last menses > year ago and confirmed by follicle stimulating hormone (FSH) blood level\r\n* Radiation-induced oophorectomy with last menses > year ago\r\n* Chemotherapy-induced menopause with last menses > year ago\r\nMale patients and their partners must use reliable methods of contraception, at least one of them a barrier method (if sexually active with a female of child-bearing potential)
Women of childbearing potential must have a negative pregnancy test within days prior to study registration; female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period ( days after CIML NK cell infusion)
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in the Duke Contraception Policy
Male patients with partners of childbearing potential must agree to use adequate contraception while on study
A female of childbearing potential unwilling to use highly effective method of contraception during treatment and for an additional hours (Period ) or hours (Period ), respectively, after the last dose of blinatumomab.
Willingness to use effective contraceptive methods during the study; if female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for >= year or surgically sterile) or is practicing two forms of contraception; sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide)
Female patients of childbearing potential must agree to use methods of contraception (including highly effective and effective method of contraception) and have a negative serum pregnancy test at screening; male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential; for both male and female patients, effective methods of contraception must be used throughout the study and for months following the last dose of study treatment
Women of childbearing potential must have a negative pregnancy test within days prior to study registration; female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period ( days after CIML NK cell infusion)
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
Female patients must not be pregnant or lactating; female patients of childbearing potential (including those < year post-menopausal) and male patients must agree to use contraception
Male patients with female partners of childbearing potential who do not agree to use two Food and Drug Administration (FDA)-accepted forms of contraception during sexual intercourse with women of child-bearing potential from the start of PD- antibody therapy and up to at least weeks from the last dose of nivolumab are excluded
Female patients of childbearing potential who do not agree to use two FDA forms of contraception during sexual intercourse from the start of PD- antibody and up to at least weeks from the last dose of nivolumab are excluded
Female patients must not be pregnant or lactating; female patients of childbearing potential (including those < year post-menopausal) and male patients must agree to use contraception
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective methods of contraception including at least one method with a failure rate of <% per year during the course of the study and for at least months after completion of study treatment
Female subjects of childbearing potential or male subjects who are unwilling to use highly effective methods of contraception during study treatment and through months after the last dose of study treatment
Female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception
Male patients with female partners who are of childbearing potential: recommendation is for male and partner to use at least effective contraceptive methods, as described above, prior to study entry and for at least months after the last dose of study drug
For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for months after discontinuation of MK-
Women of childbearing potential and men with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for days following the last dose of study medication or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for consecutive months.
Women of childbearing potential must have a negative pregnancy test within days prior to study registration; female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the dose-limiting toxicity (DLT) evaluation period
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential during sexual contact with a female of childbearing potential
Men and women enrolled in the protocol must agree to use adequate contraceptive measure when the female (patient, or partner of the male patient) has childbearing potential (the woman is not postmenopausal and has an intact uterus)
Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
Female subjects agree not to be pregnant or lactating from beginning of the study screening until months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
For female individuals of childbearing potential and male individuals of reproductive potential, willingness to use a protocol- recommended method of contraception
Male subjects must use an effective barrier method of contraception during the study and for months following the last dose if sexually active with a female of childbearing potential.
Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use methods of contraception.
Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
Female subjects with childbearing potential and male subjects should use effective contraception methods (or abstain from sexual activity) while being treated with APXM and for days following treatment
Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for days following last dose. Female subjects of childbearing potential must not be breastfeeding, or planning to breastfeed, and must have a negative pregnancy test ? days before first study drug administration. Male subjects must also refrain from donating sperm during their participation in the study.
Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through months after the last dose of treatment; female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through months after the last dose of treatment; sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within days after treatment with talimogene laherparepvec
Male patients with partners of childbearing potential must use barrier contraception.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving InO; women should not breast-feed during treatment with InO and for at least months after the final dose\r\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within days of starting protocol therapy\r\n* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for months after the last dose of InO\r\n* Men with female partners of childbearing potential should use effective contraception during treatment with InO and for at least months after the last dose of InO\r\n* Lactating females are not eligible unless they agree not to breastfeed their infants
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment if female of childbearing potential or male having sexual contact with a female of childbearing potential
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Female patients of childbearing potential and sexually-active male patients must agree to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test =< weeks prior to registration
Male patients with female partners of childbearing potential who do not agree to use two Food and Drug Administration (FDA)-accepted forms of contraception during sexual intercourse with women of child-bearing potential from the start of ipilimumab and up to at least months after ACT are excluded
Female patients of childbearing potential who do not agree to use two FDA forms of contraception during sexual intercourse from the start of ipilimumab and up to at least months after ACT are excluded
Male patients with female partners of childbearing potential and female patients of childbearing potential must agree to use contraception for four months after receiving the preparative regimen or while on vemurafenib
Male patients with female partners of childbearing potential who do not agree to use two Food and Drug Administration (FDA)-accepted forms of contraception during sexual intercourse with women of child-bearing potential from the start of vemurafenib and up to at least months after discontinuing vemurafenib are excluded
Female patients of childbearing potential who do not agree to use two FDA forms of contraception during sexual intercourse from the start of vemurafenib and up to at least months after discontinuing vemurafenib are excluded
If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment and for at least weeks after for female and weeks after for male following last treatment dose.
Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.
Willingness to avoid pregnancy and breast feeding beginning two weeks before the first MSCA dose and ending three months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must use adequate contraception in the judgment of the Investigator, such as a two barrier method or a one barrier method with spermicide or intrauterine device during trial treatment dosing and for months after the last dose of the study.
Female partners of male subjects who are of childbearing potential must also adhere to one of the following:
Women of childbearing potential or female partners of male subjects must abide by the contraception measures defined by the protocol
Male or female patients. Women of childbearing potential must agree to use highly effective methods of birth control during the trial and for at least year after the last dose of BI and month after the last dose of ibrutinib.
Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least months after the last dose of ALXN
Female patients of childbearing potential and male patients with partners of childbearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the -day nontreatment follow-up period.
Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least months after the last dose of ALXN.
Negative pregnancy test in females of childbearing potential (FCBP); male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for weeks (for females) or weeks (for males) following the last dose of study medication; acceptable forms of contraception include highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partners vasectomy and at least additional approved barrier method such as a latex condom, diaphragm, or cervical cap plus spermicide; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test within hours of the first study treatment
Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study
Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use adequate barrier methods of contraception during the study and for days after last dose of study drug and up to days after last dose of chemotherapy
Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least months after the last dose of study drug
Non-sterilized male subjects 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; 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
Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for days following last dose; acceptable forms of contraception include highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partners vasectomy and at least additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test days before first study treatment
For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and month after applying your last dose
Female patients of childbearing potential agree to and will have had effective contraception without interruption for days before starting pomalidomide
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception
Male patients must use an effective barrier method of contraception during the study and for days following the last dose of study treatment if sexually active with a female of childbearing potential
Female patients of childbearing age must have a negative serum HCG test unless prior hysterectomy or menopause (defined as age ? and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study. Sexually active male and female patients should use effective birth control
Female patients and male patients with female partners of reproductive potential must agree to use an effective method of contraception during therapy and for at least months after the last dose of study therapy.
Male and female patients able to have children must agree to use effective methods of contraception throughout the study and for up to days for female patients and days for male patients after the last dose.
WOCBP and male subjects as well as their female partners of childbearing potential must agree to use effective contraception throughout the study and for months after the last dose of KW-
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of months after study treatment.
For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for months after discontinuation of vemurafenib
If a male, an effective barrier method of contraception must be used during the study and for months after the last dose if the patient is sexually active with a female of childbearing potential.
Male patients of child fathering potential are not eligible unless they have agreed to use latex condoms during intercourse with a woman of childbearing potential while receiving treatment and for days thereafter
Male patients whose sexual partners are women of childbearing potential not using a double method of contraception during the study and months after the end of treatment; one of these methods must be a condom
Female subjects of childbearing potential must have a negative pregnancy test and both male and female (of childbearing potential) subjects must agree to use reliable methods of contraception during the study.
Patients (male and female) having procreative potential who are not using adequate contraception or practicing abstinence
Male subjects who are partners of women of childbearing potential must use a condom and spermicide and their female partners if of childbearing potential must use a highly effective method of contraception beginning at least menstrual cycle prior to starting study drug(s), throughout the entire study period, and for days after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile
Female patients must not be pregnant or lactating; female patients of childbearing potential (including those < year postmenopausal) and male patients must agree to use contraception
Patients must meet the following conditions related to reproductive health:\r\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within weeks prior to enrollment\r\n* Female patients with infants must agree not to breastfeed their infants while on this study\r\n* Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of months after study treatment
Pregnant female patients; breastfeeding female patients; males patients with partners currently pregnant, male patients able to father children and female patients of childbearing potential who are unwilling or unable to use two () highly effective methods of contraception as outlined in this protocol for the duration of the study and for days after last dose of PF-, and for months after last dose of nab-paclitaxel, gemcitabine, or both.
Male and female patients of childbearing potential and at risk for pregnancy must agree to use two () highly effective methods of contraception throughout the study and for days after the last dose of assigned study treatment.
Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least weeks after the last dose of ADCT-. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception from the time of giving informed consent until at least weeks after the patient receives his last dose of ADCT-.
Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for a minimum of days after the last dose of treatment on protocol; a patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active; female patients who are not of childbearing potential should meet at least one of the following criteria:\r\n* Have undergone hysterectomy or bilateral oophorectomy; or\r\n* Have medically confirmed ovarian failure; or\r\n* Are medically confirmed to be post-menopausal (cessation of regular menses for at\r\nleast consecutive months with no alternative pathological or physiological cause)
Male subjects able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for days after the last dose of assigned treatment.
Sexually active female subjects of childbearing potential and male subjects and their sexual partners who are of childbearing potential must agree to use contraception
Female patients (and when relevant their male partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Female subjects of childbearing age must have a negative urine HCG test unless prior hysterectomy or menopause (defined as age above and twelve months without menstrual activity). Female subjects should not become pregnant or breast-feed while on this study. Sexually active male and female subjects should use effective birth control.
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for months after the last administration of BI
For female patients of childbearing potential and male patients with partners of childbearing potential, use of an effective form of contraception with continued use for study duration and up to months or more following discontinuation of treatment drug
Male patients with partners of childbearing potential must agree to use adequate contraception while on study
For female individuals of childbearing potential, willingness to use a protocol- recommended method of contraception
Negative pregnancy test in females of childbearing potential (FCBP); male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for days following last dose; acceptable forms of contraception include highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partners vasectomy and at least additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test days before first study treatment
Female patients of childbearing potential (see Section ...) and male who are able to father a child
For female participants of childbearing potential and male participants with female partners of childbearing potential, agreement to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception throughout the course of study treatment and for at least days after the last dose of venetoclax and months after the last dose of rituximab, whichever is longer
Agreement for females of childbearing potential use acceptable methods contraception; men with female partners of childbearing potential must agree to use of latex condom and advise female partner to use additional method contraception during the study and months after discontinuation of vemurafenib
For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception; female patients of childbearing potential must agree to use two effective forms of non-hormonal contraception; effective methods of contraception include: intrauterine device (IUD); female condom; male condom; diaphragm with spermicide; cervical cap; or a sterile sexual partner; male patients with partners of childbearing potential must use barrier contraception; in addition, male patients should also have their partners use another method of contraception from the time of informed consent through the duration of study activity
Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for months after completion of study treatment
Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study
Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol
Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective methods of contraception
Male patients (with female sexual partners of childbearing potential) and female patients of childbearing potential who refuse to use effective methods of contraception
Patients who enter this study and their sexual partners who are of childbearing potential must agree to use an effective form of contraception throughout participation in this study
Female patients of childbearing potential must have a negative serum pregnancy test within days prior to taking their first dose of BGB. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for ? months after the last dose of BGB. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility, including tubal ligation, or evidence of post-menopausal status defined as any of the following:
Negative serum pregnancy test in women of childbearing potential within days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during/after months post dose; a woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant; this includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices
Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
Female patients (and female partners of male patients) of childbearing potential who are sexually active must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for weeks after the last dose of defibrotide.
Female subjects of childbearing potential and male subjects with female sexual partners of childbearing potential must agree to use an effective method of contraception
Agree to use highly effective contraception (that is, methods with a failure rate of less than percent per year) if the subject is male or a female of childbearing potential (female partners of childbearing potential of male subjects must also agree to use highly effective contraception)
Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.
Female subject of childbearing potential or male subject of reproductive potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through months after the last dose of talimogene laherparepvec/placebo or months after the last dose of pembrolizumab, whichever is later.
Use of effective contraception method during and for year following study drug dosing if female of childbearing potential or sexually active male