Woman who is pregnant or lactating or has a positive pregnancy test at screening. If a woman has a positive pregnancy test, further evaluation may be conducted to rule out ongoing pregnancy to allow the patient to be eligible
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients must have a negative pregnancy test (blood or urine) within 14 days prior to registration
WOCBP must have a negative pregnancy test (serum or urine).
Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female child-bearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy test at screening
Negative serum or urine pregnancy test within 7 days prior to starting treatment
Female patients who are both lactating and breastfeeding, who have a positive serum pregnancy test during screening, or who plan to become pregnant while in the trial or within 90 days after receiving protocol-directed treatment
Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only\r\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A negative pregnancy test (if female)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of child-bearing potential, as defined above, must have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test =< 7 days prior to registration on study
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Male subject and woman of child-bearing potential (WOCBP) must agree to use a medically-effective, double-barrier method of contraception (as defined in the ICF) to prevent pregnancy while on study and for 6 months after the last dose of IMP. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea ? 12 consecutive months without an alternative medical cause). If the subject is a WOCBP, she must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Cycle 0 Day 1 (monotherapy run-in period; prior to receiving KHK2455);
COHORT 1: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
COHORT 2: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
Female patients must have a negative urine pregnancy test within 7 days prior to registration; if urine test is positive, it should be followed by serum pregnancy test
SAFETY RUN-IN: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
RANDOMIZED PHASE II CLINICAL TRIAL: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy test
Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit; a positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic ultrasound (US); a pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects who have positive serum pregnancy test taken within 14 days of initiation of study treatment.
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Negative serum pregnancy test within 7 days prior to starting treatment
Female patients who are nursing or have a positive pregnancy test during screening are not eligible
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 72 hours of start of study treatment
FOCBP must have a negative pregnancy test within 7 days prior to registration on study
FCBP must have a negative serum or urine pregnancy test and agree to birth control.
Female patients must have a negative pregnancy test
Female subjects must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.
A negative serum pregnancy test
A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment.
Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has a positive pregnancy test within 72 hours before the first dose of study therapy
Positive serum pregnancy test
If female, the subject must have a negative serum or urine pregnancy test at Screening unless meeting non-productive potential criteria.
Either of non-reproductive potential (i.e., post-menopausal by history of age >= 50 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, history of bilateral tubal ligation, or history of bilateral oophorectomy) OR must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; subjects with a negative pregnancy test at screening beyond 72 hours prior to treatment, but who otherwise meet all other criteria, may be registered to trial but must have a repeat negative serum pregnancy test within 72 hours of treatment and such testing may be done on day of first treatment prior to administration
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have a negative result confirmed for a medically supervised urine (or serum) pregnancy test (with a sensitivity of at least 25 mIU/mL) 10-14 days prior to the first dose of IP. A second pregnancy test performed within 24 hours prior to the first dose of IP must also be confirmed to be negative prior to IP administration.
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and =< 72 hours prior to day 1 of study treatment; if the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* A woman of childbearing potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
Female patients who are lactating or have a positive serum pregnancy test during the screening period
FOCBP must have a negative pregnancy test within 7 days prior to registration on study; NOTE: a negative pregnancy test is also required within 3 days prior to first dose of pembrolizumab and therefore may need to be repeated if screening test is more than 3 days prior to first dose
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of treatment registration; female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 72 hours of study registration. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
Pregnant or breast-feeding women may not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; negative serum or urine pregnancy test within 3 days prior to enrollment
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
And have a negative serum pregnancy test at screening
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative serum or urine pregnancy test within 14 days prior to registration on study
Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of HiDAC treatment and again prior to D1 of pembrolizumab treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are breast feeding or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 28 days of study registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women with a positive pregnancy test
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Pregnancy (positive serum or urine ?HCG test) or breast-feeding
Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
INCLUSION CRITERIA FOR STRATUM C: Female subjects of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is to be treated with MK-3475 (pembrolizumab)
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
Pregnant and/or breastfeeding; patient must have a negative serum or urine pregnancy test within 2 weeks of study entry
Pregnant and/or breastfeeding; patient must have a negative serum or urine pregnancy test within 72 hours of study entry
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Negative serum pregnancy test
Women who\r\n* Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy\r\n* Have a positive pregnancy test at baseline\r\n* Are pregnant or breastfeeding
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
A WOCBP who has a positive serum pregnancy test within 72 hours prior to enrollment on study
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 7 days of the start of treatment
In female, a negative pregnancy test if experiencing menstrual periods.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female of childbearing potential: negative urine or serum pregnancy test, performed within 14 days prior to day 1 of protocol therapy\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive, a serum pregnancy test will be required
WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female patients who are both lactating and breastfeeding or have positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
Female subjects with reproductive potential must agree to undergo a medically supervised pregnancy test prior to starting study drug. The first pregnancy test will be performed at screening (within 7 days prior to first study drug administration). A pregnancy test should also be performed on the day of the first study drug administration and confirmed negative prior to dosing as well as before dosing on Day 1 of all subsequent cycles
Negative serum pregnancy test at screening
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and agree to use effective contraception; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug (if applicable)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of DCBA; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant or need to breast feed during the study period (negative serum pregnancy test required)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
have a negative serum pregnancy test at the time of enrollment,
have a negative urine pregnancy test within 24 hours prior to the first dose of study treatment, and
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative urine or serum pregnancy test done =< 72 hours prior to first treatment, for women of childbearing potential only\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first study treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential should have a negative pregnancy test within 10 days prior to on-study date; if a urine or serum test is positive or cannot be confirmed as negative, the other (urine or serum pregnancy test, whichever was not performed first) will be required
Females of childbearing potential must have a negative pregnancy test within 10 days prior to “on study” status; if a urine or serum test is positive or cannot be confirmed as negative, the other (urine or serum pregnancy test, whichever was not performed first) will be required
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women with a positive pregnancy test at enrollment or prior to administration of study medication.
Female subjects of childbearing potential as defined in Section 5.7.2 must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication or study indicated ultrasound treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication for female subjects of childbearing age
Pregnant or breastfeeding; a negative serum pregnancy test is required no more than 14 days before study entry
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only (POCBP)\r\n* NOTE: Serum or urine pregnancy test allowed; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 3 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential must have a negative pregnancy test (either urine or serum pregnancy test) within 72 hours prior to the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
STUDY TREATMENT: Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to investigational product administration and a negative urine pregnancy test within the 3 days prior to the first investigational product administration, or a negative serum pregnancy test within the 3 days prior to the first investigational product administration
Pregnancy or breastfeeding; women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy; all WOCBP MUST have a negative pregnancy test within 4 weeks prior to registration, and this must be repeated within 72 hours prior to first receiving ruxolitinib; if the pregnancy test is positive, the patient must not receive ruxolitinib and must not be enrolled in the study
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy test.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women with a positive pregnancy test
Women with a positive pregnancy test or lactating.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test within 7-10 days prior to receiving study drug
FOCBP must have a negative serum OR urine pregnancy test =< 7 days prior to registration
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Participants with borderline pregnancy tests at Screening must have a serum pregnancy test ? 3 days later to document continued lack of a positive result.
Has a negative serum pregnancy test within 7 days prior to starting treatment.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential has a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the patient to be eligible
Women with a positive pregnancy test on enrollment or prior to investigational product administration
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test =< 7 days prior to registration on study
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test (either urine or serum) within 14 days prior to registration
Female subject of childbearing potential should have a negative urine or serum pregnancy; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breastfeeding are not eligible.
And have a negative serum pregnancy test ? 10 days of cycle 1, day 1 (C1D1)
Is pregnant (confirmed by positive serum pregnancy test) or lactating
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
Female subject of childbearing potential should have a negative urine or serum pregnancy at screening and within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
To be performed within 10 business days prior to day 1: Female of childbearing potential: negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Within 14 days prior to planned start of treatment: Female of childbearing potential: negative urine or serum pregnancy test\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Females who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
For WoCBP* negative serum pregnancy test within 7 days of enrollment.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women with a positive pregnancy test on enrollment or prior to investigational product administration
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Female patients who are lactating or have a positive serum pregnancy test suggestive of pregnancy and not as a tumor marker during the screening period; if pregnancy is tested positive, treating physician will further investigate if the patient is pregnant or not; treating physician may consider repeating the serum beta-hCG at next follow up visit or refer patient to obstetrical/gynecological (OB/GYN) for further evaluation
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A negative urine dipstick pregnancy test
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, pembrolizumab (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
In female, a negative pregnancy test if experiencing menstrual periods
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication (cycle 1, day 1) (female subjects of childbearing potential); if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year)
Female subject of childbearing potential has a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the subject to be eligible
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Participants of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 10 days of initiating SBRT; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test within 7 days prior to registration\r\n* Note: FOCBP will have to have repeat pregnancy test within 24 hours of starting nivolumab, scheduled for cycle 1 day 1
Negative urine or serum pregnancy test (female of childbearing potential only)\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy test
Females of child-bearing potential (not surgically sterilized or postmenopausal [a woman who is >= 45 years of age and has not had menses for greater than 1 year]) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 120 days following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within 72 hours of receiving study drug administration; if appropriate; contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within 48 hours prior to the study drug administration
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Positive pregnant status confirmed by serum or urine pregnancy test
FOCBP must have a negative pregnancy test (serum or urine) within 7 days prior to registration on study
DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female)
Negative pregnancy test in females of reproductive age
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; this applies even if the subject practices true abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]) from heterosexual contact; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Patients of childbearing potential must have a negative urine or serum pregnancy test =< 7 days prior to registration\r\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to study registration up to the first fraction of radiation; \r\n* Note: if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential require a negative pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours of study enrollment up to administration of the dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of pembrolizumab; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
PRIOR TO LYMPHODEPLETION: For WOCBP negative serum pregnancy test within 72 hours prior to lymphodepletion
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours of study enrollment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
have a negative serum pregnancy test at screening and before Betalutin injection
A negative Hepatitis B test (HBsAg and anti-HBc) and negative HIV test during screening
Women with a positive pregnancy test.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patient of childbearing potential (WOCBP) (free from menses for > 2 years, post hysterectomy/oophorectomy, or surgically sterilized) must have a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative a serum pregnancy test will be required to be shown as negative for the patient to be eligible
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant and/or breastfeeding; patient must have a negative serum or urine pregnancy test within 72 hours of study entry
Women with a positive pregnancy test
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative serum pregnancy test
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female patients who are at least 10-years-old or are post-menarchal must have a negative serum or urine pregnancy test prior to enrollment
Positive pregnancy test in a female
Positive serum pregnancy test
Positive serum pregnancy test
Negative serum pregnancy test
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant or breastfeeding; a negative serum pregnancy test is required no more than 7 days before study entry
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Negative urine pregnancy test and/or serum pregnancy test within 7 days of initiation of therapy
Pregnant and/or breastfeeding; premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry
Pregnant and/or breastfeeding; premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry (Arm B)
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 7 days of start of study treatment
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant or breastfeeding; a negative serum pregnancy test is required no more than 7 days before study entry
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative pregnancy test
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
Pregnant and/or breastfeeding; patient must have a negative serum pregnancy test within 14 days of study entry
Negative serum or urine pregnancy test
For females of childbearing age, they may participate it they: a. have a negative serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy test will be performed within 24 hours (hrs) of starting therapy and both negative pregnancy tests will be required for starting therapy); b. agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment
Pregnant and/or breastfeeding; patient must have a negative serum pregnancy test within 7 days of study entry if premenopausal
Negative pregnancy test at the time of SRS in any patient who could be pregnant
Female patient of childbearing potential has a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the patient to be eligible
Female patients with reproductive potential who do not have a negative blood or urine pregnancy test at screening
Negative serum or urine pregnancy test within 72 hours of commencement of treatment in premenopausal women
Pregnant or nursing (lactating) women, female study participants of reproductive potential must have a negative serum or urine pregnancy test within 48 hours before infusion
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Negative serum pregnancy test with 72 hours prior to start of study drug
For Phase I and II: Negative urine or serum pregnancy test.
DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female)
Pregnancy or breastfeeding; female patients who are post-menarchal must have a documented negative pregnancy test
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to first doses of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug
Negative pregnancy test, if applicable
Negative pregnancy test (serum or urine) in premenopausal women
Patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only\r\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours of receiving first dose of study treatment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days of enrollment; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A negative serum pregnancy test (if female and aged between 18-55 years old).
Female patients who are lactating, breastfeeding, or have a positive pregnancy test
WOCBP must be using highly effective and medically accepted method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study ; 12. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug.
Female subject of childbearing potential should have a negative urine or serum pregnancy test < 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative pregnancy test
For females, a negative pregnancy test
Have a negative urine pregnancy test at baseline.
Positive pregnancy test (for pre-menopausal women)
Negative blood or urine pregnancy test at screening
220 Females with a positive pregnancy test.
For childbearing female patients, negative serum or urine pregnancy test at screening
WOCBP must have a negative pregnancy test within 24 hours prior to Study Day 0.
A negative serum or urine pregnancy test during Screening,
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Negative urine/serum pregnancy test (females only) at the time of screening and within 24 hours of study treatment, if applicable
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Negative urine/serum pregnancy test (females only) at the time of screening and within 24 hours of study treatment, if applicable
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment
Female patients who are lactating or have a positive pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of child-bearing potential (intact uterus) MUST have a negative serum or urine human chorionic gonadotropin (HCG) test within 72 hours prior to receiving the first dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
Female patient of childbearing potential has a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the patient to be eligible
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative (serum or urine) pregnancy test within 72 hours before the first study-drug dose; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the participant to be eligible
Female patients with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 72 hours prior to administration of any treatment
To be performed within 28 days prior to day 1 of protocol therapy: Female of childbearing potential: negative urine or serum pregnancy test\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
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
FOCBP must have a negative pregnancy test =< 7 days prior to registration
The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential should have a negative urine or serum pregnancy test within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative pregnancy test
Female patients with reproductive potential who do not have a negative blood or urine pregnancy test at Screening or who are lactating.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A WOCBP who has a positive urine pregnancy test within 72 hours prior to study treatment start; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Woman of childbearing potential (WOCBP): negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women with a positive pregnancy test on enrollment or prior to investigational product administration
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only\r\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* NOTE: Merck requires an additional pregnancy test if eligibility pregnancy test is > 72 hours prior to first dose
Female subject of childbearing potential should have two negative urine or serum pregnancy test, one at 10-14 days before first dose of study drug and another within 24 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy per institutional guidelines for high-dose melphalan and autologous transplant; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are pregnant and/or breastfeeding; patient must have a negative serum pregnancy test within 14 days of study entry
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy; WOCBP must have a negative serum or urine pregnancy test within 72 hours before the start of the investigational product
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Females only:\r\n* Urine or serum pregnancy test negative assessed within seven (7) days prior to the start of therapy
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable
And have a negative urine pregnancy test at Screening
agree to take a pregnancy test prior to starting study medication and throughout the study participation.
Women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Pregnant and/or breastfeeding; patient must have a negative serum pregnancy test within 14 days of study entry
A negative pregnancy test (if female).
Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Have a negative urine or serum pregnancy test at screening
Have 2 negative pregnancy tests as verified by the Investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence[2] from heterosexual contact.
For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1
Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and subject also should agree to use an adequate method of contraception starting with screening through 30 days after the last dose of study therapy (if sexually active).
Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as (by other than medical reasons):
Agree to have a medically supervised serum pregnancy test with sensitivity of at least 25 mIU/mL obtained at Screening. A serum pregnancy test is to be performed within 72 hours prior to Day 1 of starting study therapy on Cycle 1 Day -6, and within 72 hours prior to Day 1 of every subsequent cycle, and at the Treatment Discontinuation Visit. The subject may not receive IP until the Investigator has verified that the result of the pregnancy test is negative.
Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL); (Note that the screening serum pregnancy test can be used as the test prior to starting IP in the pharmacokinetics phase if it is performed within the 72-hour timeframe), and
Negative serum or urine pregnancy test (investigator's discretion; sensitivity of at least 25 mIU/mL) within 72 hours prior to starting IP in the extension phase. (Note: subjects must have negative serum or urine pregnancy test prior to dosing on Day 1 of each treatment cycle in the extension phase.)
Female patients with reproductive potential who do not have a negative blood or urine pregnancy test at Screening.
Negative serum pregnancy test
Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.
WOCBP must have a negative serum pregnancy test within 14 days prior to the first dose of ipilimumab/nivolumab
Women who are breastfeeding or pregnant as evidenced by positive serum pregnancy test
Female participants who are lactating and breast feeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
Negative urine/serum pregnancy test, if applicable
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving retreatment with study medication
Negative serum or urine pregnancy test within 3 days prior to start of study treatment.
Negative urine pregnancy test
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum pregnancy test at enrollment; a urine or serum pregnancy test will be performed within 48 hours before the RNA CART19 infusion
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant or breastfeeding women; female study participants of reproductive potential must have a negative urine pregnancy test of enrollment; a serum pregnancy test will be performed within 2 weeks before infusion
Female patients who are lactating or have a positive blood pregnancy test during the screening period
Women with a positive pregnancy test on enrollment or prior to investigational product administration
A negative serum pregnancy test (if female and aged between 18-55 years old).
Pregnant and/or breastfeeding; patient must have a negative urine pregnancy test within 14 days of study entry
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable
Documentation of negative pregnancy test.
Female of childbearing potential only: negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 14 days prior to day 1 of protocol therapy)
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
And have a negative urine or serum pregnancy test at screening
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry (positive urine tests are to be confirmed by serum test)
Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment.
Females patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Negative urine or serum pregnancy test done =< 7 days prior to registration for females who are post-menarchal
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Women who are breastfeeding or pregnant as evidenced by positive serum pregnancy test
Female patients must be surgically sterile, post-menopausal (for at least 1 year), or have negative results from a pregnancy test performed as follows:\r\n* At screening, on a serum sample obtained within 14 days prior to the first study drug administration, and\r\n* Prior to dosing, on a urine sample obtained on day 1 of treatment if it has been > 7 days since obtaining the serum pregnancy test result
Women with a positive pregnancy test at enrollment or prior to administration of study medication
Pregnant and/or breastfeeding; patient must have a negative urine pregnancy test within 5 days of study entry
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 72 hours of study registration. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
Pregnant and/or breastfeeding: patient must have a negative pregnancy test within 14 days of study entry
Female subjects of childbearing potential should have a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Positive pregnancy test in a female
Must have a negative serum pregnancy test
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
Female patients who are pregnant or breastfeeding or have a positive serum pregnancy test during the screening period
Negative pregnancy test at screening
Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)
Negative serum pregnancy test; if, on cycle 1 day 1, greater than 72 hours has elapsed since the last negative result, a serum pregnancy test must be repeated and be negative on cycle 1 day 1 (C1D1) for the patient to remain eligible
Positive pregnancy test
must have a negative urine pregnancy test at Screening, and
Female patient of childbearing potential has a negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; the serum pregnancy test must be negative for the patient to be eligible
Women with a positive pregnancy test on enrollment or prior to investigational product administration
A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
Negative serum pregnancy test at screening.
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participant who is post-menarchal must have a negative urine or serum pregnancy test
Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug
Pregnant and/or breastfeeding; premenopausal women must have a negative serum or urine pregnancy test within 14 days of study entry
Pregnant (positive pregnancy test)
Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 48 hours prior to any initial study procedure based on a serum pregnancy test; both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug; if subject uses appropriate contraceptive methods (the use of two forms at the same time) from the time of the initial serum pregnancy test, then the subsequent pregnancy test can be done within 72 hours of receiving study drug administration; if appropriate contraceptive measures are not begun immediately with the first serum pregnancy test, then subsequent serum pregnancy tests must be done within 48 hours prior to the study drug administration
FCBP must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within 10-14 days before day 1 cycle 1 and the second pregnancy test must be performed within 24 hours of day 1 cycle 1; the subject may not receive lenalidomide until the treating investigator has verified that the results of these pregnancy tests are negative, and must agree to ongoing pregnancy tests; for patients already on Revlimid, continuation of current testing schedule is permitted as long as it is not interrupted during the transition to CRd therapy
Pregnant or lactating women; the safety of this therapy on unborn children is not known; female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Female subject who are lactating or have a positive serum pregnancy test during the screening period
Patient must not be pregnant and/or breastfeeding; patient must have a negative serum pregnancy test within 14 days of study entry
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable
Negative pregnancy test in females of reproductive age
Negative pregnancy test for WOCBP
Female research participants >= 10 years of age or post-menarchal must not be pregnant (confirmed by serum or urine pregnancy test within 1 week of study enrollment) or breastfeeding
Women with a positive pregnancy test
Positive serum or urine pregnancy test
Patients who are pregnant; pregnancy will be confirmed by negative urine test
Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment) (Female only)
DONOR: Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment) (Female only)
Women of childbearing potential (WOCBP), defined above who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding\r\nNOTE: before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab or HDI; if the pregnancy test is positive, the patient must not receive ipilimumab or HDI and must not be enrolled in the study
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
Female patients must have a negative urine or serum pregnancy test at screening (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal)
The patient is pregnant (confirmed by urine or serum pregnancy test) or lactating
Women with a positive pregnancy test on enrollment or before investigational product administration
Female patients who are lactating or have a positive serum or urine pregnancy test during the Screening period.
Negative pregnancy test (if female in reproductive years)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are pregnant or lactating – or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test =< 72 hours before enrollment and randomization and must have a negative pregnancy test =< 72 hours prior to treatment start)
Female subjects of childbearing potential as defined in Section 5.7.2 must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female patients must either be of non-reproductive potential (i.e. post-menopausal by history of age >= 60 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test (beta-human chorionic gonadotropin [HCG]) at the screening visit; if screening visit pregnancy test was completed within 7 days of first treatment visit it does not need to be repeated; patients with a negative pregnancy test at screening beyond 7 days prior to treatment, but who otherwise meet all other criteria, may be registered to study but must have a repeat negative serum pregnancy test within 7 days of treatment and such testing may be done on day of first treatment prior to administration)
Negative pregnancy test.
Pregnancy (positive serum or urine pregnancy test) or breast feeding
Negative pregnancy test (if female in reproductive years)
Premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment; postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test
Women with a positive pregnancy test
Negative pregnancy test if applicable
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
And have a negative blood pregnancy test at the time of screening
And have a negative serum pregnancy test at screening
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before administration of the first dose of study drug.
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Have a negative serum pregnancy test (? -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
Negative serum pregnancy test for females
Female participants who are lactating and breastfeeding or have a positive pregnancy test during the Screening period.
Female participants who are lactating and breastfeeding or have a positive pregnancy test during the Screening period.
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Female patient who are lactating or have a positive serum pregnancy test during the screening period
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Negative serum pregnancy test.
Urine pregnancy test for women of childbearing potential (defined as not post-menopausal for 12 consecutive months or no previous surgical sterilizations); a negative urine pregnancy test is required within 48 hours of initiating study drug
Female patients who are lactating or have a positive serum pregnancy test within 72 hours of initiation of treatment, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable; pregnancy testing is not required for postmenopausal or surgically sterilized women
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Positive pregnancy test.
Post-menarchal female has had negative serum pregnancy test within 7 days prior to enrollment
INCLUSION CRITERIA - HPC-A CELL DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 7 days prior to enrollment (if female)
(Female only) negative serum or urine pregnancy test (to be conducted within 7 days prior to enrollment)
(Female only) is not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to admission for transplant)
DONOR: (Female only) is not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
Woman who is pregnant or lactating or has a positive pregnancy test at screening. If a woman has a positive pregnancy test, further evaluation may be conducted to rule out ongoing pregnancy to allow the patient to be eligible.
A negative serum pregnancy test (if female and aged between 18-55 years old).
WOCBP must have a negative serum pregnancy test within 7 days prior to receiving investigational product and a negative urine pregnancy test on Day 1 of each Cycle;
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female)
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of alisertib.
Patient is pregnant as confirmed by positive serum or urine pregnancy test within 14 days prior to enrollment
Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female)
All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable
Negative serum or urine pregnancy test within 7 days prior to and including the morning of day -7 (first potential day of research blood draw and tumor biopsy)
A negative serum pregnancy test (if female)
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on day 1 before first dose of study drug, if applicable
Patient must not be pregnant and/or breastfeeding; patient must have a negative urine pregnancy test within seven days of study entry
Negative serum or urine pregnancy test at the time of first dose for WOCBP.
Inadequate organ functions, positive pregnancy test.
Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
DONOR: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female)
Negative pregnancy test
Female participants who are both lactating and breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug
Women with a positive pregnancy test on enrollment or prior to investigational product administration
Pregnancy (positive serum or urine pregnancy test) or breast feeding;
Sexually active WOCBP must use an effective method of birth control during the course of study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Negative pregnancy test
Negative pregnancy test
Negative pregnancy test
Negative pregnancy test
Women with a positive pregnancy test at study entry.
negative serum pregnancy test
Negative urine pregnancy test (negative serum confirmatory pregnancy test if urine test is positive)
Negative pregnancy test
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* If a pregnancy occurs, the study doctor must be notified; the study doctor should notify the study sponsor as well as Amgen of the pregnancy, discuss any follow-up with the subject (and/or his partner), and ask for information on the pregnancy outcome; the patient should be asked if she wishes to consent to follow up through the Amgen pregnancy surveillance program\r\n* If the female partner is already pregnant when the male subject begins treatment with talimogene laherparepvec, he must refrain from any sort of sexual activity that could expose his partner or the unborn baby to talimogene laherparepvec through semen, or wear a latex condom during sexual activity while receiving treatment with talimogene laherparepvec and for at least 3 months after the last talimogene laherparepvec administration
Pregnant and/or breastfeeding; patient must have a negative serum or urine pregnancy test within 72 hours of study entry
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative pregnancy test within 14 days prior to registration on study
Must have a negative serum pregnancy test at screening and day -1, and
Pregnant or nursing women; a negative pregnancy test (serum or urine) =< 3 days prior to starting study treatment
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Pregnant and/or breastfeeding; patient must have a negative pregnancy test within 14 days of study entry
Female subjects of childbearing potential must have either a negative urine or a negative serum pregnancy test within seven (7) days of first dose of pembrolizumab; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential, must have either a negative urine or a negative serum pregnancy test within seven (7) days of first dose of pembrolizumab; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participants who are lactating and breast-feeding or a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug.
Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
FOCBP must have a negative urine or serum pregnancy test within 14 days prior to registration on study.
Patients who have a negative urine pregnancy test prior to enrollment; this should be done as part of pre-admission testing prior to surgery (within 14 days of study enrollment)
Pregnancy or nursing: All females of childbearing age must have a negative serum or urine pregnancy test < 7 days before study drug administration
Negative pregnancy test at study registration
Currently pregnant (assessed by serum pregnancy test)
Women who are pregnant at time of enrollment; pregnancy will be assessed at enrollment using urine pregnancy test
Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test =< 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
Not pregnant (confirmed by a pregnancy test)
Pregnancy: All female patients < 55 years old (yo) will be administered a urine pregnancy test prior to enrollment
Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Women of child-bearing potential (intact uterus) should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Patients who are pregnant; the absence of pregnancy will be confirmed by negative urine test
Female participant of childbearing age must not be pregnant (confirmed by serum or urine pregnancy test within 1 week of eligibility) or lactating
Negative pregnancy test
Patients who are pregnant are excluded; pre-menopausal women must have a negative pregnancy test; patients that are post-menopausal, or that have had a hysterectomy do not need to have a pregnancy test
Negative pregnancy test
(Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 14 days prior to enrollment)
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (urine or serum)
Satisfactory results of screening safety labs, urine pregnancy test and drug test
Post-menopausal or negative urine and/or blood pregnancy test
They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
A positive urine pregnancy test during the screening period. Women who are one year post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test.
All WOCBP MUST have a negative pregnancy test prior to first receiving study medication
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
Positive pregnancy test on day of surgery
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial of full hysterectomy will not be subject to a urine pregnancy test
Positive urine drug test at screening visit
Pregnant and/or breastfeeding; female patients must have a negative urine pregnancy test within 14 days of study entry
Negative pregnancy test =< 7 days prior to randomization
Positive pregnancy test
Negative pregnancy test (urine and blood tests)
Have two negative pregnancy tests as verified by the investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence2 from heterosexual contact.
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Positive pregnancy test
has a negative pregnancy test on the day of vaccination, and
has a negative pregnancy test on the day of vaccination, and
The patient is pregnant as confirmed by urine or serum pregnancy testing,
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Currently known to be pregnant; (Note that urine pregnancy tests will be performed prior to the DXA and pQCT studies; positive pregnancy test at that time would preclude participation; a positive pregnancy test will be immediately reported to the patient’s primary oncology provider)
Pregnancy or nursing patients will be excluded from the study; a pregnancy test will be done prior to the MR examination for postmenarchal teenage girls, in whom pregnancy may be possible; only patients with a negative pregnancy test will be included in the study
Pregnancy or nursing patients will be excluded from the study; a pregnancy test will be done prior to the MR examination for postmenarchal teenage girls, in whom pregnancy may be possible; only patients with a negative pregnancy test will be included in the study
Positive serum pregnancy test in WOCBP
Female patients who are lactating or have a positive pregnancy test during the screening period
Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT and [18F] Fluciclovine PET scans; a negative test will be necessary for such patients to undergo research PET imaging
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to C11-AMT PET scan; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study
Positive pregnancy test
Positive serum pregnancy test for females
Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans; the serum pregnancy test must be performed within 48 hours prior to the initial research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
Determination of pregnancy status: female patients that are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of multi-tracer PET scans; a negative test will be necessary for such patients to undergo research PET imaging
Positive urine pregnancy test or currently breast-feeding
Positive urine pregnancy test or currently breast feeding
Negative serum pregnancy test
If a female and pre-menopausal, must have a negative pregnancy test.
Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
Females who are pregnant as confirmed by a positive serum or urine pregnancy test or are breastfeeding.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Breastfeeding or pregnant; serum pregnancy test will be conducted
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
And have a negative urine or serum pregnancy test at screening
Positive serum or urine pregnancy test within 24 hours of imaging prior to injection of radiotracer (for women of childbearing potential per Radiology Department clinical guidelines)
Determination of pregnancy status: female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
For females: negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
Female patients must have a negative urine pregnancy test
For females: negative urine pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Pregnant or breastfeeding - if the subject is female, the investigator will provide a urine pregnancy test at no cost to the subject; the subject will take the pregnancy test immediately before participating in this study
Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects with reproductive potential must have negative serum or urine pregnancy test
Is female participant who are lactating and breast-feeding or a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required