Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation
Male and female participants of reproductive potential must agree to effective contraception during and after study treatment
A male is eligible to enter and participate in this study if he and his female sexual partner in the reproductive age group agree to use effective methods of contraception
All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
Adults of reproductive potential not employing two forms of birth control: \r\n* Males having partners who are female with child-bearing potential must agree that they and/or their partners will use at least two effective contraceptive methods (including one barrier method) when engaging in reproductive sexual activity throughout the study from the time of informed consent, and will avoid conceiving for days after the last dose of CC-
Women and men of reproductive potential must agree to use highly effective contraception when sexually active.
Female subjects who are pre-menopausal or have experienced menopause for less than years and who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than hours before starting AG-. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use effective forms of contraception from the time of giving informed consent, during the study, and for months (females and males) following the last dose of AG-. Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier methods (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization.
Must not be pregnant or breastfeeding; male or female of reproductive potential must agree to use effective contraception for the duration of study participation
Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)
Male or female participant of reproductive potential must agree to use appropriate methods of contraception for the duration of study treatment and for at least days after last dose of protocol treatment
All subjects with preserved reproductive potential must agree to practice abstinence or employ contraceptive measures for the duration of treatment and for weeks following final dosing; all male subjects are considered to have reproductive potential; female subjects of reproductive potential are those who: ) are not at least years old and have no menses for consecutive months; or ) have not been rendered surgically sterile (having undergone hysterectomy and/or bilateral salpingo-oophorectomy); female subjects of reproductive potential must have a negative serum pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin ([hCG]) within days of first day of drug dosing
Female subjects with reproductive potential must have a negative serum pregnancy test within days prior to the start of the therapy. Subjects with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal for at least consecutive months. Females of reproductive potential as well as fertile men and their partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study, and for months (females and males) following the last dose of AG- or AG-. A highly effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier method (e.g., synthetic condoms, diaphragm or cervical cap with spermicidal foam, cream, or gel) or male partner sterilization
Male or female subjects of reproductive potential who do not agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for days after the last study treatment
Any of the following:\r\n* Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception\r\n* Nursing persons
Effective contraception for both male and female subjects if the risk of conception exists; women of childbearing potential and men able to father a child must agree to use a method of effective contraception; effective contraception is required throughout the study and for at least month after avelumab treatment, months after last dose of trabectedin for women of reproductive potential, and months following the last dose of trabectedin for males with female partners of reproductive potential
Patients of reproductive potential must agree to follow the contraception requirements.
Be of non-reproductive potential OR
Participants of childbearing/reproductive potential must use effective contraception.
Reproductive function:
Male subjects of reproductive potential in the combination treatment must be willing to use acceptable methods of effective contraception during treatment and through months after the last dose of pembrolizumab.
Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment
Patient must be willing to use effective contraception if female with reproductive capability
Failure to use contraception in patients with preserved reproductive capacity
Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment
Patients with reproductive potential must agree to use an effective non-hormonal method of contraception during therapy, and for at least months after the last dose of study therapy.
Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least months after completion of the study treatment
Patients of reproductive potential and their partners must agree to use an effective (> % reliability) form of contraception during the study and for weeks following the last study drug administration
Both genders must use contraception if of reproductive capacity
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for months after the last dose of study treatment. Additional Inclusion Criteria for Cohort :
Women who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing two highly effective and acceptable forms of contraception throughout their participation in the study and for days after last dose of study drug
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use effective forms of contraception.
Males and females of reproductive potential must use two forms of effective contraception during the duration of the trial and for minimum of months after last dose of tocilizumab, trastuzumab, or pertuzumab; a woman of reproductive potential is defined as a premenopausal female with intact uterus and ovaries
Both female and male patients of reproductive potential must agree to avoid pregnancy or impregnating a partner (respectively) while receiving drug and for days after last dose of study drug
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy (chemotherapy, trastuzumab, pertuzumab, and estrogen deprivation therapy) and for at least months after the last dose of study therapy
Subjects who have a positive pregnancy test, are pregnant, lactating or have reproductive potential and not practicing an effective means of contraception
Subjects who are pregnant, lactating or of reproductive potential and not practicing an effective means of contraception
Patients of reproductive potential must agree to use effective contraception during the period of therapy
Female patients with reproductive potential must have a negative serum pregnancy test within days prior to first study drug administration. Patients with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not experienced natural menopause (i.e., who have not menstruated at all) for at least consecutive months (i.e., have had menses at any time in the preceding consecutive months). Women with reproductive potential as well as fertile men and their partners who are female with reproductive potential must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study, and for days (females and males) following the last dose of AG
In case of use of oral contraception, women must be stable on the same pill for a minimum of months before taking study treatment. Women who are not of reproductive potential (defined as either < years of age, Tanner Stage , post-menopausal for at least consecutive months (i.e. have had no menses) or have undergone hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) are eligible without requiring the use of contraception. Women who are not yet of reproductive potential are to agree to use acceptable forms of contraception when they reach reproductive potential if within year of CTL or if CAR cells are present in the blood by PCR. Acceptable documentation includes written or oral documentation communicated by clinician or clinician's staff of one of the following:
Patients (male or female) of reproductive potential must agree to use an effective method of contraception (as discussed with treating physician) from the time consent is signed, during study therapy, and for at least days after the last dose of study therapy.
Patients of reproductive potential must practice effective contraception while on study and for at least calendar days following treatment.
Men or women of reproductive ability who are unwilling to use effective contraception or abstinence for months after treatment
Pregnancy or breast-feeding female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for days following the last dose of RO; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment; women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method; female patients should not become pregnant while participating in this research study or for days following therapy; male patients should not father a child while in this research study or for days following therapy
Female subjects with reproductive potential must agree to undergo medically supervised pregnancy test prior to starting study drug. The first pregnancy test will be performed at screening (within days prior to first study drug administration), and on the day of the first study drug administration and confirmed negative prior to dosing. Subjects with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal (i.e., who have not menstruated at all) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months). Females of reproductive potential, as well as fertile men and their partners who are female of reproductive potential, must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study and for days (females and males) following the last dose of AG-. A highly effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization.
Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study
COHORT A: Persons of reproductive potential unwilling to use an adequate method of contraception throughout treatment and for at least weeks after ipilimumab is stopped
COHORT B: Persons of reproductive potential unwilling to use an adequate method of contraception throughout treatment and for at least weeks after ipilimumab is stopped
Female subjects with reproductive potential must have a negative serum pregnancy test within days prior to the start of therapy. Subjects with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal (i.e., who have not menstruated at all) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months). Females of reproductive potential as well as fertile men and their partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use two highly effective forms of contraception from the time of giving informed consent, during the study and for days (females and males) following the last dose of AG-. A highly effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization.
Female subjects who are lactating, pregnant or both male and female subjects with reproductive potential who refuse to practice medically accepted methods for contraception over the period from study consent to days following the last dose of study treatment
Female or male patients of reproductive capacity unwilling to use methods appropriate to prevent pregnancy are excluded; effective contraception is required for at least months following the last administration of aflibercept
Pregnant or lactating women, or adults of reproductive potential who do not agree to use adequate contraception during study treatment
All patients of reproductive potential must agree to use adequate contraception
E . Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period.
Pregnant women or women of reproductive ability who are unwilling to use effective contraception during the study and for months after stopping treatment
Subjects who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception
Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (b-HCG) pregnancy test within days before the first dose of study drug. Women of reproductive potential and men with female partners of childbearing potential must agree to consistently use highly effective contraception between signing the informed consent and days after the last administration of study drug
Women with reproductive capability must be willing to use effective contraception
Patients of reproductive potential must agree to use an effective (> % reliability) form of contraception during the study and for months following the last study drug administration
Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for weeks after the last dose of study drug
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for months after the last dose of study drug.
Female and male patients of reproductive potential must agree to use effective contraception from screening until days after discontinuing study treatment.
Male or female of reproductive potential has agreed to use effective contraception for the duration of study participation
Reproductive Function
Female or male of reproductive capacity unwilling to use methods of contraception to prevent pregnancy during this study. Participants unwilling to use methods of contraception to prevent pregnancy for months after the last dose of RO due to the potential for prolonged half-life of RO in the liver.
Male or female participant of reproductive potential must agree to use appropriate methods of contraception for the duration of study treatment and for at least days after last dose of protocol treatment
Patients with reproductive potential must agree to use at least one form of barrier contraception prior to study entry and for up to days beyond the last administration of study drug.
Women of reproductive capability will be enrolled; contraception is not necessary
If female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib
Patients (both men and women) with reproductive potential not willing to use an effective method of contraception
Is male OR is female who is not of reproductive potential OR is female who is of reproductive potential and agrees to avoid becoming pregnant in the days prior to receiving study drug, while receiving study drug and for at least days after last dose of study drug
Female or male participant who is not of reproductive potential, or, if of reproductive potential, agrees to true abstinence or to use (or have their partner use) acceptable methods of birth control from the time of consent through days after the last dose of study drug
Men of reproductive potential must use condoms
Female patients with reproductive capability must be willing to use effective contraception
Male or female patients who are sexually active and of reproductive potential must agree to use an effective contraceptive method throughout the study and for at least days after last avelumab treatment administration; abstinence is an acceptable form of contraception
Sex and Reproductive Status