Women of childbearing potential must have a negative beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 14 days prior to registration
Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.
Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at Screening for women of child bearing potential who are sexually active
Negative urine ?-human chorionic gonadotropin (?-HCG) pregnancy test for fertile women at screening and confirmed by serum pregnancy test in the 48 hours prior to OPN-305 administration
Serum creatinine ?1.5 mg/dL or a measured creatinine clearance ?60 mL/min; and Negative serum ? hCG (human chorionic gonadotropin) test in women of childbearing potential (defined as women ?50 years of age, or >50 years of age with a history of amenorrhea for ?12 months prior to study entry).
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non-childbearing potential are those who are post-menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential
Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial; pregnant women are excluded from this study; breastfeeding is not allowed during the course of the study; female patients must have a negative pregnancy test (human chorionic gonadotropin beta subunit [B-HCG] test in urine or serum) prior to commencing study treatment
Have a negative beta-human chorionic gonadotropin (?-hCG) pregnancy test at time of study entry and within 14 days prior to planned first dose of investigational product, and
Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening before enrollment/randomization. Adolescent/young women who are pregnant or breastfeeding are ineligible for this study
Female of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test result within 3 days of first study dose; female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have beta-HCG pregnancy test waived
Patients who are women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented =< 7 days prior to registration
Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening
PART I: Negative serum beta human chorionic gonadotropin (HCG) if female and of childbearing potential
PART II: Negative serum beta HCG if of childbearing potential
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Pregnancy (absence to be confirmed by beta-human chorionic gonadotropin test in women of child-bearing potential) or lactation
Negative serum beta-human chorionic gonadotropin (HCG) in females, and agreement to the use of effective contraception in males and females of childbearing potential, IS REQUIRED
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
Positive urine pregnancy test (women of child bearing potential only) (QuickVue One Step human chorionic gonadotropin [hCG])
Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening, within 24 hours of the first dose of anti-OX40 antibody, and every four weeks while on study treatment; women who are pregnant or breastfeeding are ineligible for this study
Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test.
A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)
Females of childbearing potential must have a negative beta human chorionic gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Negative serum beta-human chorionic gonadotropin (hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
Female patients of childbearing potential must have a negative serum beta?human chorionic gonadotrophin (?-hCG) pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of ribociclib
Female subjects of childbearing potential should have a negative urine or serum pregnancy test beta human chorionic gonadotropin (beta-hCG) within 72 hours prior to receiving the first dose of study medication
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration; women of childbearing potential must not be pregnant, must not be breast-feeding, and must practice adequate contraception for the duration of the study, and for 30 days after the last dose of study medication
Negative beta-human chorionic gonadotropin (hCG) pregnancy test for female patients of child-bearing potential =< 7 days before starting neratinib therapy
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
Negative urine or serum beta-human chorionic gonadotropin (BHCG) for women of childbearing potential only (within 7 days of registration)
For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within 14 days before the first dose of WT1-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT1-specific T cells will be counseled to use effective birth control during participation in this study and for 12 months after the last T cell infusion
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
Negative urine beta-human chorionic gonadotropin (B-HCG) in women of child-bearing potential within 7 days prior to start of treatment
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks after the last dose of the study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Negative serum or urine beta-human chorionic gonadotropin (beta-HCG) test (female of childbearing potential only), to be performed locally within the screening period
Negative serum or urine beta-human chorionic gonadotropin (B-HCG) test (female patient of childbearing potential* only), to be performed locally within the screening period
Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
Female patients of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within three weeks of mobilization
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for female patients of childbearing potential
All post-menarchal females must have a negative serum beta-human chorionic gonadotropin (beta HCG); sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after
Patients may not be pregnant or breast feeding; females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of S-equol
Negative serum or urine pregnancy test beta-human chorionic gonadotropin (beta hCG) within 2 weeks prior to receiving the first dose of study medication for women of childbearing age
Negative pregnancy test (beta [B]-human chorionic gonadotropin [HCG]) within 7 days prior to registration for women of childbearing potential
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential within one week prior to enrollment
Negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
Women of childbearing potential must have a negative beta (B)-human chorionic gonadotropin (HCG) pregnancy test documented within 7 days prior to registration
Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening
Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) (to be performed within 7 days prior to start of study treatment)
Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [BhCG]) within 2 weeks of protocol entry
Females of childbearing potential (> 7 years old [yo]) must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test prior to initiation of cytoreductive therapy; sexually active patients will be informed of the risk of not using adequate contraception
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to treatment
Women must not be pregnant or lactating; women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) serum pregnancy test and agree to refrain from breast-feeding; patients of childbearing potential agree to use an effective form of contraception during chemotherapy and for 90 days following the last chemotherapy treatment
Negative serum or urine beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening for patients of childbearing potential
DONOR: Not be pregnant as defined by negative serum (beta human chorionic gonadotropin [beta HCG]) pregnancy test in females of childbearing potential (non-childbearing potential defined as premenarchal, previous surgical sterilization, or postmenopausal for > 12 months)
Women of childbearing age must have a negative serum pregnancy test (beta-human chorionic gonadotropin) within 72 hours prior to initiating the conditioning regimen and be willing to not become pregnant by using effective contraception while undergoing treatment and for at least 3 months after the last dose of azacitidine
Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test result within 14 days before the first dose of WT1-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT1-specific T cells will be counseled to use effective birth control during participation in this study and for 12 months after the last T cell infusion
DLI DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning apheresis
Female patients of childbearing age will be excluded if they are pregnant as assessed by serum beta-human chorionic gonadotropin (b-HCG) or urine pregnancy test; a serum b-HCG test or urine pregnancy test will be performed no greater than 14 days prior to study registration
Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to receiving the first dose of study medication and agree to the use of effective methods of contraception while on study
Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [B HCG]) within 72 hours of receiving the first dose of rituximab
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 7 days prior to taking the first dose of study medications
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (?-human chorionic gonadotropin) within 7 days prior to randomization.
For female patients of childbearing potential (i.e. have had a menstrual period within the past 12 months): a positive serum pregnancy test (?-human chorionic gonadotropin) within 7 days prior to enrollment.
and, have a negative serum pregnancy test at Screening, (Note: Subjects with elevated serum beta human chorionic gonadotropin (?hCG) and a demonstrated non-pregnant status through additional testing are eligible), and
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening and a negative urine pregnancy test prior to the first dose of study drug
Negative serum pregnancy test (serum HCG) within 7 days of study treatment if female and of childbearing potential (non-childbearing is defined as greater than one year post-menopausal surgically sterilized). Since beta-HCG may be falsely elevated as a result of malignancy, women of child-bearing potential who have an elevated serum beta-HCG level are eligible for enrollment if they have two Transvaginal Ultrasound (TVUS) scans one week apart along with serial beta-HCG levels two weeks apart that are inconsistent with pregnancy and a Gynecology consult to ensure that the beta- HCG level was at a value high enough to see pregnancy with TVUS.
Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);
Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) performed locally within 72 hours (hrs) prior to first dose
All post-menarchal females must have a negative beta-HCG
Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
FOCBP must have a negative pregnancy test (beta-human chorionic gonadotropin [HCG] test in urine or serum) within 7 days prior to registration on study (Note: The test will have to be repeated if cycle 1 day1 is more than 3 days from registration)
Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (B-hCG) pregnancy test result within 14 days prior to the first dose of imipramine
Negative serum or urine beta-human chorionic gonadotropin (HcG) test (female patient of childbearing potential only) performed within 72 hours of prior to first study dose
Pregnancy test (urine or serum beta-human chorionic gonadotropin [HCG]) done within 72 hours before randomization must be negative (for women of childbearing potential only); if urine pregnancy results are positive or cannot be confirmed as negative, a serum pregnancy test will be required
A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [b-hCG]) or urine test prior to the first dose of study drug
DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within two weeks of apheresis
Women of childbearing potential must have a negative serum ?-human chorionic gonadotropin or urine pregnancy test at screening
DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotrophin (HCG) test within three weeks of mobilization
Pregnancy during vaccine administration; female participants of childbearing potential must have a negative pregnancy test (serum beta human chorionic gonadotropin [B-HCG]) prior to administration of the first vaccine dose
Women who are pregnant or breastfeeding; women of child-bearing potential must have a negative pregnancy test (beta- human chorionic gonadotropin [B-HCG] test in urine or serum) prior to commencing study treatment
Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
Women of childbearing potential must have a negative serum beta (B)-human chorionic gonadotropin (HCG) pregnancy test at initial screening and within 3 days prior to registration
Females of childbearing potential must:\r\n* Agree to using a reliable form of contraception (eg, oral contraceptives, intrauterine device, double barrier method of condom and spermicidal) for at least 28 days prior to the first dose of any study drug, during the treatment period (and treatment/follow-up if receiving study drug), and for at least 70 days after the last dose of any study drug\r\n* Have a negative serum beta-human chorionic gonadotropin (beta-HCG) at screening
Female patients of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (hCG)
Woman of childbearing potential must have 2 negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) during screening, the first one within 10 to 14 days prior to the first dose of any component of study treatment and the second within 24 hours prior to the first dose of any component of study treatment
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Females of childbearing potential must have a negative beta human chorionic gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Women of childbearing potential must have a negative urine or serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.
Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication
Negative blood or urine beta-human chorionic gonadotropin (?- HCG) pregnancy test within 7 days prior to Day 1 for women of childbearing potential.
Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test result within 7 days prior to the first dose of ibrutinib; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Pregnant and/or lactating females are excluded; a negative beta-human chorionic gonadotropin [B-hCG]) is required during Screening, and a separate local assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of Test Article
Negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
Negative serum or urine beta-human chorionic gonadotropin (HCG) pregnancy test at screening for patients with childbearing potential
Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within 7 days prior to the first dose of SGN-35; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Negative serum pregnancy test (beta human chorionic gonadotropin [beta HCG]) within 7 days of starting study, if of child-bearing potential
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration Inclusion Criteria for Crossover:
Pregnancy or breast feeding; female patients must have a negative pregnancy test (beta-human chorionic gonadotropin [HCG] test in urine or serum) prior to commencing study treatment and must agree with the use of effective contraception during the study and for three months following last dose of nintedanib
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
Negative pregnancy test (serum beta-human chorionic gonadotropin [B-HCG]) within 7 days of starting study treatment is required in women of childbearing potential; NET patients with positive B-HCG are eligible if pregnancy can be excluded by vaginal ultrasound or lack of expected doubling of B-HCG
Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (>= 1 year before screening), total hysterectomy or menopause (defined as 12 consecutive months of amenorrhea); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use dual contraception for the duration of study participation and for 120 days after the last dose of talazoparib
Negative serum pregnancy test (beta-human chorionic gonadotropin [B-hCG]) within 72 hours before starting study treatment for all women of childbearing potential
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 7 days prior to treatment
DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning growth factor of choice
Negative urine beta-human chorionic gonadotropin (HCG) or negative serum quantitative beta-HCG or within 2 weeks prior to registration for women of childbearing potential
Women of childbearing potential (including premenopausal women and women less than 12 months after menopause) must have a negative beta-human chorionic gonadotropin (hCG) urine pregnancy test within 4 weeks of registration
Premenopausal women of child bearing potential must have a normal urine or serum beta-human chorionic gonadotropin (HCG) prior to enrollment, and must agree to use effective contraception during treatment with nivolumab and for at least 5 months following the last dose of nivolumab
Women of childbearing potential must have a negative pregnancy test (serum or urine beta human chorionic gonadotropin [HCG]) prior to initiation of chemotherapy; both female and male breast cancer patients who are sexually active have to agree to practice contraception while participating in the trial and for 3 month after completion of therapy
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Females of child-bearing potential (pre-menopausal) must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test at screening
Negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
Negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential
Urine or serum beta-human chorionic gonadotropin (HCG) or serum HCG = negative (if female patient of childbearing potential)
Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening
Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 72 hours of start of therapy
Female patient of childbearing potential must have a negative serum or urine pregnancy test (beta-human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study medication and agree to the use of effective methods of contraception while on study
Female patient of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (b-hCG) within 7 days prior to receiving the first dose of vorinostat
Female patients of childbearing potential (WOCBP) must have a negative serum pregnancy test beta-human chorionic gonadotropin (hCG) within 7 days of the first treatment
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
Negative serum beta human chorionic gonadotropin (?hCG) test (for women of childbearing potential only)
Patients of childbearing potential must agree to use some form of adequate birth control during the periods they receive chemotherapy and any post-chemotherapy medications related to the transplant; females of child bearing potential must have a negative serum beta-human chorionic gonadotropin (B-HCG) within 1 week of starting therapy
DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning G-CSF mobilization
Females must not be pregnant (negative human chorionic gonadotropin test within 72 hours prior to receiving the first dose of study medication) or breastfeeding
Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy)
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) or urine pregnancy test at screening
Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) pregnancy test at screening; pregnancy testing is not required for: (a) women who have been post-menopausal for at least 2 years without menses; or (b) women who are surgically sterile (e.g. by means of hysterectomy, tubal ligation, etc.)
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening within 7 days of enrollment
Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only), to be performed locally within the screening period
Negative beta human chorionic gonadotropin (bHCG) within 14 days prior to study entry if patient is pre or perimenopausal
Negative pregnancy test (beta human chorionic gonadotropin [HCG]) within 14 days of study drug initiation for pre- or perimenopausal subjects with an intact uterus
Negative serum beta-human chorionic gonadotropin (B-HCG) test (female patient of childbearing potential only) performed locally within 72 hrs prior to first dose
If a female patient is of childbearing potential, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) documented within 72 hours of the first administration of study drug
Male or non-pregnant and non-lactating female; if a female patient is of childbearing potential, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [b-hCG]) documented within 72 hours of the first administration of study drug
Negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening for patients of childbearing potential
A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
Have a negative pregnancy test Beta Human Chorionic Gonaditrophin(ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy.
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test within 14 days of day (D)1 of neoadjuvant chemotherapy for women of childbearing potential
If female patient is of child bearing potential, she must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) documented up to 72 hours (hrs) prior to administration of first study drug
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) performed locally within 72 hours (hrs) prior to first dose
Negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening, performed no more than 72 hours prior to treatment initiation; for women of childbearing potential
A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 72 hours prior to receiving the first dose of study treatment.
Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin beta subunit [B-hCG] pregnancy test) within 72 hours prior to receiving the first dose of vorinostat; male patients enrolled in this study should also agree to use an adequate method of contraception for the duration of the study
DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning apheresis
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only)
Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) or urine pregnancy test within 7 days prior to treatment initiation and when clinically indicated every 4 weeks +/- 7 days while receiving study drugs, as shown in study calendar; women who are pregnant or breastfeeding are ineligible for this study
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Within 4 weeks of therapy start, women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening and must adhere to the scheduled pregnancy testing
Negative serum beta (?) human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within 72 hours prior to first dose
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum beta-human chorionic gonadotrophin [beta-hCG] test) in females of reproductive potential), not lactating or if of reproductive potential agrees to follow one of the options listed in protocol from 30 days prior to the first dose of study medication and until 120 days after the last dose of study treatment.
Negative beta-human chorionic gonadotropin (betaHCG) pregnancy test among females of childbearing age
Pregnancy or breast feeding; female patients with child-bearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [B-HCG] test in urine or serum) prior to commencing study treatment
If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study\r\n* Women < 50 years old must have a negative pregnancy test (urine human chorionic gonadotropin [HCG] or serum betaHCG) within 2 weeks of beginning chemotherapy
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within three weeks of apheresis
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Women of childbearing age will be required to have a negative human chorionic gonadotropic (HCG) test within seven days of surgery
Female subjects capable of reproduction must have a negative beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test result within 7 days prior to first Investigational Product dose
Negative pregnancy test (females of child bearing potential) within =< 1 week of rasburicase dose and use of efficient contraceptive method (both males and females); pregnancy test may be performed on serum (human chorionic gonadotropin [HCG]) or urine (HCG)
RECIPIENT: Negative serum or urine beta?human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (?-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as >12 months since last menses) or are surgically sterilized do not require this test
Women of child-bearing potential must also have a negative urine pregnancy test (beta-human chorionic gonadotropin [HCG]) within 72 hours of receiving treatment
Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans in accordance with the standard policy of the Medical Imaging Service at our facility; women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
Women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betaHCG) within the previous 24 hours of the procedure
All post-menarchal females must have a negative beta-human chorionic gonadotropin (HCG) within 2 weeks prior to receiving the dose of 124I-MIBG; males and females of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus
Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
Negative serum ? -HCG (beta human chorionic gonadotropin) test for female of child bearing potential at screening and a negative urine pregnancy test at Day 1.
Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented within 7 days prior to treatment. Have given written informed consent prior to any study-specific procedures.
Negative urine or serum beta-human chorionic gonadotropin (?-HCG) pregnancy test within 7 days prior to the Cycle 1, Day 1 visit, for women of childbearing potential.
Female patients of child-bearing potential (pre-menopausal and not surgically sterilized) who are breast-feeding or have a positive blood beta-human chorionic gonadotropin pregnancy test at Screening
Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization;
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Positive beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study.
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.
Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months
Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
Negative beta-human chorionic gonadotropin (HCG) test in a woman of child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Pregnancy: positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
Positive pregnancy test in a female patient of childbearing potential defined as not post-menopausal for twelve months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 24 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide
Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females
Negative pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding; a woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months
Negative beta human chorionic gonadotropin (HCG) test within 30 days in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization); pregnancy testing is not required for post-menopausal or surgically sterilized women
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
Negative beta human chorionic gonadotropin (HCG) test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and if fertile, males and females must agree to use contraceptives
Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study
Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
Negative beta human chorionic gonadotropin (HCG) test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide
Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
Negative beta human chorionic gonadotropin (HCG) test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
Positive beta human chorionic gonadotropin (HCG) within 7 days prior to consent in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
Subjects who have a positive serum human chorionic gonadotropin (hCG), are pregnant or lactating are ineligible
Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 10 mIU/mL); pregnancy is ruled out by a beta hCG test completed if necessary with an ultrasound
Women of childbearing potential who currently are pregnant (human chorionic gonadotropin positive [HCG+]) or who are not practicing adequate contraception
Females who are pregnant (beta-human chorionic gonadotropin positive [beta-HCG+]) or breast-feeding
Female subjects who are nursing or pregnant (positive serum or urine beta-human chorionic gonadotropin [B-hCG] pregnancy test)
DONOR: females who are pregnant (positive serum beta-human chorionic gonadotropin [B-HCG]) or uninterruptible breastfeeding
Female subjects who are nursing or pregnant (positive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test) at screening or pre-dose on day 1
Performed within 10 business days of treatment initiation with the exception of beta-human chorionic gonadotropin (HCG) (72 hours), if applicable: Absolute neutrophil count (ANC) >= 1000 /uL.
Pregnant or breastfeeding women who do not consent to stop breast-feeding while on study treatment and for 30 days after the use of the investigational vaccine where pregnancy is confirmed by a positive, rising human chorionic gonadotropin (hCG) laboratory test
Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause
Female patients who are pregnant confirmed by beta human chorionic gonadotropin (bHCG) laboratory (lab) test
Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test)
Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [beta-HCG+]) or breast feeding
Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause; [women are considered postmenopausal if they are >= 12 months without menses, in the absence of endocrine or anti-endocrine therapies]
Normal beta-human chorionic gonadotropin (HCG) (per the local laboratory assay) within 14 days of RPLND
Subject is pregnant or nursing; serum or urine beta-human chorionic gonadotropin (HCG) must be checked in all non-postmenopausal patients or patients of childbearing potential
WOCBP who have a positive beta-human chorionic gonadotropin (hCG) test or are breastfeeding
Female patients who are diagnosed as pregnant by beta human chorionic gonadotropin (hCG) testing (per institutional practice) or breast-feeding
Female patients who are pregnant (positive beta-human chorionic gonadotropin [B-HCG]) or breastfeeding
Pregnant or nursing (to be confirmed with quantitative human chorionic gonadotropin [HCG] testing)
Negative beta-human chorionic gonadotropin (hCG) pregnancy test within 2 weeks before enrollment for premenopausal women of reproductive capacity and for women less than 12 months after menopause; pregnancy screening will be conducted for women up to the age of 50 years per institutional standard
Pregnant or need to breast feed during the study period (negative beta-human chorionic gonadotropin [HCG] test required), or unable to maintain use of contraception while on study and for 31 weeks after the last dose of nivolumab
DONOR:\r\n* Donors will be excluded if they are an identical twin of the recipient\r\n* Females who are pregnant (positive serum beta human chorionic gonadotropin beta [? HCG]) or uninterruptible breastfeeding\r\n* HIV seropositive\r\n* Donors receiving experimental therapy or investigational agents unless approved by the protocol chair
Negative serum beta-human chorionic gonadotropin (HCG)
Women of childbearing potential who currently are pregnant (beta-human chorionic gonadotropin [HCG]+) or who are not practicing adequate contraception
Pregnant or lactating females; women of non-childbearing potential is defined as women who are postmenopausal (no menses for > one year) or who have had a hysterectomy and will not require beta-human chorionic gonadotropin (B-hCG) testing
Women who are pregnant (determined by high titer of serum beta-human chorionic gonadotropin [HCG]) or breast-feeding; (women with reproductive potential must practice adequate contraception)
Pregnant or nursing women; women of child-bearing age must be tested for urinary or plasma beta-human chorionic gonadotropin (hCG)
Women of childbearing potential who currently are pregnant (beta-Human chorionic gonadotropin positive [HCG+]) or who are not practicing adequate contraception
Subject is pregnant, has a positive serum human chorionic gonadotropin (hCG) or is lactating
Subjects who are pregnant, have a positive serum human chorionic gonadotropin (hCG) or are lactating
Beta human chorionic gonadotropin (beta HCG) negative
Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding.
Pregnant women are excluded from this study, where pregnancy is confirmed by a positive serum beta-human chorionic gonadotropin (hCG) laboratory test; breast-feeding should be discontinued
Women who are pregnant or breast-feeding; women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test obtained within 7 days before the start of study treatment
Women of childbearing potential who currently are pregnant (beta-human chorionic gonadotropin [HCG]+) or who are not practicing adequate contraception or who are breastfeeding
Negative ?-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. [Women are considered postmenopausal if they are ?12 months without menses, in the absence of endocrine or anti-endocrine therapies.]
Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
Female patients who are pregnant (positive b-human chorionic gonadotropin [HCG]) or breastfeeding
Female patients who are pregnant (positive beta-human chorionic gonadotropin [HCG]) or breastfeeding will be excluded from study entry; sexually active men and women must use contraceptive techniques during and for 4 weeks following completion of maintenance therapy
The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG], if applicable) or is breastfeeding
Negative serum human chorionic gonadotrophin (HCG) pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after menopause
Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause
Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG); a serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential
Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
Is pregnant (confirmed by beta human chorionic gonadotrophin [?-HCG]) or lactating.
Patient is pregnant (confirmed by serum beta- b-human chorionic gonadotropin [HCG] if applicable) or is breastfeeding
HAPLO-IDENTICAL DONOR: Pregnancy (positive serum or urine beta-human chorionic gonadotropin [HCG]) or breastfeeding; women of childbearing age must avoid becoming pregnant while on the study
DONOR: Pregnancy (positive serum or urine beta-human chorionic gonadotropin [b-HCG]) or breastfeeding; women of childbearing age must avoid becoming pregnant while on the study
Pregnant women with a positive (blood beta-human chorionic gonadotropin [B-HCG]) pregnancy test are excluded from this study
Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [HCG+]) or breast feeding
Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception
Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [b-HCG+]) or breast feeding
Pregnancy: women of childbearing potential who are beta(B)-human chorionic gonadotropin (HCG) positive (+)
Pregnant or breast feeding women; positive pregnancy test (serum or urine beta-human chorionic gonadotropin [HCG]) for women of reproductive potential
Women of childbearing potential who are lactating, pregnant or there is the likelihood of becoming pregnant within the coming 12 months; a positive serum beta-human chorionic gonadotropin test at time of screening for entry into study
Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Female subjects must not be pregnant as documented by a negative beta-human chorionic gonadotropin (beta-hCG) test with a minimum sensitivity 25 IU/L or equivalent unit of beta-hCG at Screening and Baseline, or breastfeeding.
Pregnancy (positive serum beta human chorionic gonadotropin [b-HCG]) or breastfeeding
Pregnant or breast-feeding; pre-menopausal patients must have a negative serum human chorionic gonadotropin (HCG) within 14 days of enrollment
Pregnant (i.e., positive beta-human chorionic gonadotropin [HCG]) or breast feeding
Pregnant or need to breast feed during the study period (negative urine beta-human chorionic gonadotropin [HCG] test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED
Women who are pregnant; patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta human chorionic gonadotropin (HCG), or best judgement of the investigator, pregnancy testing is not required per protocol to determine study eligibility
Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine beta-human chorionic gonadotropin [?-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating (the possibility of pregnancy has to be excluded by negative urine beta-human chorionic gonadotropin [beta-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
Women who are pregnant (confirmed by serum beta [b]-human chorionic gonadotropin [HCG] in women of reproductive age) or breast feeding
Pregnant women and women who are breast feeding will be excluded from this study; (the Vanderbilt University Medical Center radiology “MRI Procedure Screening Form” will be used to identify and exclude subjects who are pregnant or breastfeeding; a urine pregnancy test/or serum beta human chorionic gonadotropin [HCG] will also be performed for each pre-menopausal subject)
Pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG] in women of reproductive age) or breast feeding
The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [?-HCG] pregnancy test) or breastfeeding
The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [?-HCG] pregnancy test) or breastfeeding
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [?-hCG]) at the Screening Visit and the Baseline Visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Females of childbearing potential must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation, ie
Women of childbearing potential (WOCBP) only: Negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
Women of childbearing potential (WOCPB) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours of starting study therapy
Women of child bearing potential who are pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing.
WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 0 to 48 hours before the first dose of study drug
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 24 hours prior to the start of the study drug
PHASE II INCLUSION CRITERIA: Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 24 hours prior to the start of the study drug
Patient must be non-pregnant and non-nursing; women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to randomization
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per liter [IU/L] or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of the start of study drugs
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [?-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of ?-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; elevated HCG for other explained and documented reasons is allowed
Ability to become pregnant (or already pregnant or lactating); women and men who want to participate have to agree to use two highly effective forms of contraceptive prior to study entry, for the duration of study participation, and for 30 days following completion of therapy, to be eligible; women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
Women of childbearing potential (WOCBP) must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) performed within 24 hours prior to the start of nivolumab; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
Pregnant or breast-feeding patients; women of childbearing potential must have a pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of HCG) performed within 24 hours prior to the start of nivolumab, and a negative result must be documented before start of treatment
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG] hormone) within 24 hours prior to the start of study drug
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 1 days prior to the start of study drug
Participants who are women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of study drug
Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of the study enrollment
Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of the study drug.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) during screening and within 48 hours prior to the first dose of nivolumab
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
Pregnancy or lactating females; women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to Step 2 registration
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (sensitivity =< 25IU HCG/L) within 4 weeks prior to registration and will be repeated within 72 hours prior to the start of study drug administration
WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
Pregnant or breastfeeding; for elotuzumab arm: women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days of study treatment start (24 hours prior to the start of elotuzumab)
Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days before study entry; pregnancy test must be repeated if performed > 14 days before starting study drug
Women must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; for WOCBP, follow up pregnancy tests will be performed every 4 weeks (+/-1 week) during the study regardless of dosing schedules
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG); the first should be performed within 10 to 14 days and the second within 24 hours prior to the start of the study drug; a prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to receiving nivolumab; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Cohort 3B (Combination Expansion): Osteosarcoma participants who progressed in Cohorts 1 or 2B and opt to receive combination therapy.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 3 days prior to the start of study drug
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
Women of childbearing potential must have a negative serum or urine pregnancy test (sensitivity < 25 IU human chorionic gonadotropin (HCG)/L) within 72 hours prior to the start of study drug
Women Of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test (i.e., minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician(s) immediately. **Refer to pg. 10 of the protocol for the formal definition of a WOCBP.**
Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic [?-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of ?-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of thoracic radiation therapy
Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment
Women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of human chorionic gonadotropin [HCG]) before entry onto the trial
Participant is neither pregnant nor nursing:\r\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of HCG) within 7 days prior to start of study medication; it is the investigators’ responsibility to repeat the pregnancy test should start of treatment be delayed
Women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of human chorionic gonadotropin [HCG]) before entry onto the trial and within 7 days prior to start of study medication; it is the investigators’ responsibility to repeat the pregnancy test should start of treatment be delayed
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 international units/liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
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 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
A woman of childbearing potential must have a negative highly sensitive serum [beta-human chorionic gonadotropin (?-hCG)] or urine pregnancy test at (minimum sensitivity 25 International units (IU)/ liter (L) or equivalent units of HCG) within 7 days prior to the first dose of study drug
Women must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
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 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of the first dose of study drug(s)
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to the start of nivolumab.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatments
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 3 days before the start of ipilimumab
Females must not be breast-feeding or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative Screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Positive pregnancy screening test with a minimum sensitivity of 25 IU/L of human chorionic gonadotropin (hCG) within 72 hours of registration; breastfeeding women are also excluded
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours before the start of ipilimumab
All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [?-hCG]) at the screening visit and the baseline visit; a pregnancy test needs to be performed within 72 hours of the first dose of study drug
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) with 28 days prior to randomization
Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per litre (IU/L) or equivalent units of B-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of nivolumab
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) during screening for eligibility assessments and enrollment and within 24 hours prior to the start of study drug.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin hormone) within 24 hours prior to the start of study drug.
Women should not be lactating and, if of childbearing age, should have a negative pregnancy test (beta-human chorionic gonadotropin [b-HCG] test; serum or urine, minimum sensitivity 25 IU/L or equivalent units of b-HCG) within two week of registration in the study
Women of childbearing potential and men should practice effective methods of contraception. Women of childbearing potential should have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin within 7 days prior to the start of PRI 724.
WOCBP must have a negative serum or urine pregnancy test [minimum sensitivity 25 UI/L or equivalent units of human chorionic gonadotrophin (HCG)] within 24 hours prior to the start of investigational product
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab
Women should not be lactating and, if of childbearing age, should have a negative pregnancy test (beta-human chorionic gonadotropin [b-HCG] test; serum or urine, minimum sensitivity 25 IU/L or equivalent units of b-HCG) within two week of registration in the study
Women must not be pregnant or breastfeeding; WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to registration
WOCBP must have a negative serum or urine pregnancy test (sensitivity ? 25IU human chorionic gonadotropin [hCG]/L) within 72 hours prior to the start of study drug administration
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [?-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units [IU]/L or equivalent units of ?-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Women who are breast feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) done within 14 days of first dosing and urine test within 72 hours of first dosing
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to surgery
Negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours (hrs) prior to registration in women of child-bearing potential (WOCBP)
Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG).
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 25 IU/L or equivalent units of B-hCG. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Female participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Pregnant women are excluded from this study; breastfeeding should be avoided; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Pregnant or breastfeeding - methotrexate is Pregnancy Category X - has been reported to cause fetal death and/or congenital abnormalities. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female patients who are pregnant or breast-feeding (confirmation that the patient is not pregnant must be by a negative pregnancy test result obtained during screening; pregnancy testing is required of women of childbearing potential but not required for post-menopausal or surgically, sterilized women)
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (unless there is reasonable certainty that beta-hCG is coming from the tumor); pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
Pregnant or breastfeeding - interferon products (e.g., Infergen®) is Pregnancy Category C, (i.e., animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.). Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (?-HCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta?human chorionic gonadotropin (beta?hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post?menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women (woman not of child-bearing potential is defined as any woman whose menstrual periods have stopped in the past 12 consecutive months or have had a complete hysterectomy or both ovaries surgically removed)
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotrophin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential
Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (Unless there is reasonable certainty that beta-hCG is coming from the tumor). Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Female subject is either post-menopausal at least 1 year before the screening visit or surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, or agree to completely abstain from heterosexual intercourse; female subject is not pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening (within 7 days prior to D1 of treatment); pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta (?)-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
Women of childbearing potential and all men must agree to use an approved form of contraception (e.g. oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm, condom, abstinence or surgical sterility) prior to study entry and for the duration of study participation through 30 days after the last dose of BL-8040. Confirmation that female subjects are not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening, unless the female has recently (within 8 weeks) undergone egg harvest, which would result in the (beta-hCG) test to be elevated without pregnancy; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women