All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing).
Females of childbearing potential must have a negative serum pregnancy test within days prior to prior to registration for protocol therapy; NOTE: Female subjects are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Females must not be lactating or pregnant at screening or baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than hours before the first dose of study drug. All females will be considered to be of childbearing potential unless they are postmenopausal (at least months consecutive amenorrheic, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing). Females of childbearing potential must not have had unprotected sexual intercourse within days prior to study entry and must agree to use a highly effective method of contraception, from the last menstrual period prior to initiation of treatment, during Treatment Cycles, and for days after the final dose of study treatment, and have a male partner who uses a condom. Highly effective contraception includes:
All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing).
Females of childbearing potential who (Note: all females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing].):
Females of childbearing potential must have a negative serum pregnancy test within hours prior to registration; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy at least weeks prior to study registration) or they are naturally postmenopausal for at least consecutive months without an alternative medical cause
PHASE I: Females of childbearing potential must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least days following discontinuation of protocol therapy; females of childbearing potential must have a negative pregnancy test within days prior to registration for protocol therapy; patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months; females must not be pregnant or breastfeeding; in rare cases of an endocrine-secreting tumor, human chorionic gonadotropin (hCG) levels may be above normal limits (falsely-positive) but with no pregnancy in the patient; in these cases, there should be a repeat serum hCG test (with a non-rising result) to rule out pregnancy; upon confirmation of results and discussion with the Sponsor-Investigator, these patients may enter the study
PHASE IB: Females of childbearing potential must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least days following discontinuation of protocol therapy; females of childbearing potential must have a negative pregnancy test within days prior to registration for protocol therapy; patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months; females must not be pregnant or breastfeeding; in rare cases of an endocrine-secreting tumor, hCG levels may be above normal limits (falsely-positive) but with no pregnancy in the patient; in these cases, there should be a repeat serum hCG test (with a non-rising result) to rule out pregnancy; upon confirmation of results and discussion with the sponsor-investigator, these patients may enter the study
Females of childbearing potential must have a negative pregnancy test within days prior to being registered for protocol therapy; NOTE: subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within days prior to registration. \r\n* NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months. Documentation of postmenopausal status must be provided.
Females of childbearing potential must have a negative serum pregnancy test within three days ( hours) prior to initiating study treatment; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Females of childbearing potential must have a negative serum pregnancy test within days prior to registration; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Negative serum pregnancy test for females of child bearing potential; females are considered to not be of child bearing potential if they are either:\r\n* Postmenopausal (defined as at least months with no menses without an alternative medical cause; in women < years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of months of amenorrhea, a single FSH measurement is insufficient); \r\n* Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least weeks prior to screening;\r\n* Has a congenital or acquired condition that prevents childbearing
Females of childbearing potential must have a negative serum pregnancy test within days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or they are naturally postmenopausal for at least consecutive months, or her male partner has had a vasectomy at least months prior to screening (The sterilized male partner must be her only sexual partner.).
Females of childbearing potential must have a negative serum or urine pregnancy test and must agree to use adequate contraception for the duration of the study and six months after; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault or intrauterine device), and abstinence; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as months with no menses without an alternative medical cause); women will be considered post-menopausal if they have been amenorrheic for the past months without an alternative medical cause
Females of childbearing potential must have a negative serum pregnancy test within days prior to registration; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
CELL PROCUREMENT: Females of childbearing potential must have a negative serum pregnancy test within hours prior to procurement; NOTE: females are considered of child bearing potential unless they are premenarchal, surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
LYMPHODEPLETION: Females of childbearing potential must have a negative serum pregnancy test within hours prior to hours prior to lymphodepletion; NOTE: Females are considered of child bearing potential unless they are premenarchal, surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Females of childbearing potential must have a negative pregnancy test within days prior to being registered for protocol therapy\r\n* NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy).If a patient of childbearing potential is neither surgically sterile nor postmenopausal, contraceptive measures must start either prior to or at Screening and continue throughout the entire study period and for months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded
Surgically sterile (bilateral tubal ligation, hysterectomy)
Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP
Females of childbearing potential (all post pubertal females will be considered to be of childbearing potential unless they have early menopause [amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing]) who:
Women of childbearing potential must have a negative serum pregnancy test within days prior to registration for protocol therapy\r\n* NOTE: Women are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
Females of childbearing potential must have a negative serum pregnancy test within hours prior to initiating study medications; NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months; documentation of postmenopausal status must be provided
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test at the baseline visit (within days of the first dose of study treatment); females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after discontinuation of study treatment; the only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least month before start of study treatment, hysterectomy, or bilateral oophorectomy with surgery at least month before start of study treatment)
If a female of child-bearing potential, patient has negative serum pregnancy test results within weeks before baseline and is not lactating\r\n* Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as months with no menses without an alternative medical cause)
Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as months with no menses without an alternative medical cause)
are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least weeks before dosing and who do not agree to use the same contraceptive during the study and for days after study drug discontinuation. All females will be considered of childbearing potential unless they are postmenopausal (at least months consecutive amenorrheic, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing).
Females of childbearing potential must have a negative serum or urine pregnancy test within days prior to registration for protocol therapy; patients are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least month before dosing)
Patients must not be pregnant, breastfeeding or of child-bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a total hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than months (if patient is uncertain of amenorrhea for months, a pregnancy test will be done to confirm pregnancy status). Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < pm/mL to confirm ovarian senescence.
Females of childbearing potential must have a negative serum pregnancy test within hours (hrs) prior to treatment; NOTE: Females are considered of child bearing potential unless they are surgically sterile, have a congenital acquired condition that prevents childbearing (have undergone a hysterectomy, bilateral tubal ligation/occlusion, bilateral salpingectomy or bilateral oophorectomy at least weeks prior to screening) or they are naturally postmenopausal for at least consecutive months without an alternative medical cause; in women < years of age a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of months of amenorrhea, a single follicle stimulating hormone (FSH) measurement is insufficient
Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception; females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of beta-human chorionic gonadotropin [beta-Hcg] at the baseline visit [within days of the first dose of study treatment]); females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after discontinuation of study treatment; the only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least month before start of study treatment, hysterectomy, or bilateral oophorectomy with surgery at least month before start of study treatment); current, ongoing protocols containing pertuzumab have included continuous pregnancy monitoring during the trial and for six months after the last dose of study drug is administered; women should be warned not to become pregnant for at least six months after completion of treatment
All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
Currently pregnant or breast-feeding; all females must have a negative serum or urine pregnancy test at the baseline visit; females of childbearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for days after discontinuation of study treatment; subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy)
Patients must not be of child-bearing potential; patients are considered not of child-bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than months; patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < pm/mL to confirm ovarian senescence
Females of childbearing potential and males must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least days following discontinuation of protocol therapy; females of childbearing potential must have a negative pregnancy test within days prior to registration for protocol therapy; patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months; sexually active male subjects are also required to use an effective birth control method during the entire study period and up to months following study treatment
Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as months with no menses without an alternative medical cause or follicle-stimulating hormone/luteinizing hormone levels consistent with a menopausal state)
All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least month before dosing).
Females of childbearing potential must have a negative serum pregnancy test within hours prior to dose mirvetuximab soravtansine; NOTE: Sexually mature females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Female patients without childbearing potential (spontaneous amenorrhea for > months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > months before Screening) are eligible for inclusion without contraceptive use restriction.
Note: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least month before dosing).
Participant must not be pregnant or breastfeeding; females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or post-menopausal (defined as >= months with no menses without an alternative medical cause); serum pregnancy test (for females of childbearing potential) negative at screening
Females of childbearing potential must have a negative pregnancy test =< days prior to registration; all females of childbearing potential who are sexually active, must agree to use a highly reliable method of contraception to prevent pregnancy; these include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections) \r\n* NOTE: Females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> months since last menses)
Females of childbearing potential must have a negative pregnancy\r\n* NOTE: females are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> months since last menses)\r\n* NOTE: females using hormonal contraceptives should be switched to non-hormonal forms of contraception
Females of childbearing potential must have a negative urine or serum pregnancy test within days prior to registration; NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least consecutive months
Sexually active female of reproductive capability ie, WOCBP, has agreed to use a medically accepted form of contraception from time of registration to completion of study therapy through weeks ( months) after last dose of NVB or BV; Note: Females of non-child-bearing potential are those who are postmenopausal for > year or who have had a bilateral tubal ligation or hysterectomy
All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least month before dosing).