Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of radiation therapy (RT) and for at least 28 days following the last dose of sorafenib (whichever is later)
Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test must be obtained within 14 days prior to registration\r\n* Women of childbearing potential must use adequate contraception from study start to one month after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence; men must practice complete abstinence or agree to use an adequate contraception method from study start to one month after the last dose of protocol therapy
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion
Women of childbearing potential and male participants agree to practice adequate contraception
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 8 weeks after the final dose
Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for 12 months following study drug administration
Men whose sexual partners are women of childbearing potential not using a double method of contraception during the study and 3 months after the end of treatment; one of these methods must be a condom
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential and male participants must practice adequate contraception
Pregnancy or lactation; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Women of childbearing potential and male participants must practice adequate contraception
Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception. All patients (men and women) must agree to use an effective method of contraception (if applicable) up to three months after treatment discontinuation.
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961 (expected to be greater than 5 half-lives from pre-clinical data)
Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
Pregnant or lactating females; women of childbearing age will agree to use contraception during the protocol
Patients capable of childbearing are using adequate contraception
Women of childbearing potential must agree to follow instructions for acceptable contraception from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.
Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception.
Women of childbearing potential or men who is unwilling to use an appropriate method of contraception during the study period and for 6 months after completing treatment with Debio 1347; oral or injectable contraceptive agents cannot be the sole method of contraception
Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation
Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 7 months after final nivolumab study treatment
Pregnancy or women of childbearing potential not willing/able to use contraception during protocol treatment
Patients are not of childbearing potential or they must agree to use a physical method of contraception.
Because the effects of zydelig on the developing human fetus are unknown, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Female subjects of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of zydelig. Male subjects must agree to use an adequate method of contraception starting with the first dose of the study drug Zydelig. Female and male participants must agree to use contraception for at least 30 days after the last dose of Zydelig. Women of childbearing potential is defined as women who continues to have menstrual periods, have not had a tubal ligation, or the removal of fallopian tubes, ovaries or uterus.
Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Women of childbearing potential (per University of Wisconsin Carbone Cancer Center [UWCCC] policy definition) must agree to use effective contraception as discussed with treating oncologist for the duration of the study
Women of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
Women of childbearing potential and male participants must practice adequate contraception
For women of childbearing potential using a contraceptive pill, an additional barrier method is necessary. A list of adequate contraception methods is provided in the patient information.
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and men must agree to use adequate contraception
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after completion of treatment
Women who are pregnant or breast-feeding; NOTE: Premenopausal women on ovarian suppression therapy are still considered of childbearing potential; women of childbearing potential and men must be strongly advised to use an accepted and effective method of non-hormonal contraception; acceptable contraception includes barrier methods (e.g., condoms or diaphragm) or intrauterine devices (IUDs) (these may include low-dose hormones at the discretion of the study chair)
Men and women must be willing to use appropriate contraception throughout study and for 6 months after
DONOR: Women of childbearing potential and men must agree to use adequate contraception with two different forms, including one barrier method, during participation in the study and for 2 weeks following dosing with BL-8040; abstinence is acceptable if this is the established and preferred contraception for the subject
Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding
Breastfeeding, pregnant, women of childbearing potential not using contraception
Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy
Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test at baseline; women/men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom); (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential); patients must agree to continue contraception for 30 days from the date of the last study drug administration
Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
Women of childbearing potential and male participants must agree to practice adequate contraception
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy
Women of childbearing potential and male participants must practice adequate contraception
Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation; adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
patients who are not pregnant, committed to using adequate contraception if of childbearing age
Pregnant or lactating women; women of childbearing potential must use effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-128.
Male participants of childbearing potential must agree to use an adequate method of contraception.
Women of childbearing potential must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception.
Women of childbearing potential and men must agree to use adequate contraception
Signed written informed consent forms HLA SCREENING: • Women of childbearing potential must use adequate contraception MAIN SCREENING:
Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation
Pregnant or lactating women; women of childbearing potential not using a reliable and appropriate contraceptive method; postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients will agree to continue the use of acceptable form of contraception for 30 days from the date of last drug administration
Men and women of childbearing potential who do not practice contraception; women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Males & women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for the duration of study, & for 6 months after last dose of study drug
Women who are pregnant or lactating, or who are of childbearing potential , and men\n             who do not use a barrier method
Sexually active men with partners of women of childbearing potential must agree to practice effective methods of contraception during the study and for 6 months after the last treatment
Is pregnant; women of childbearing potential and male participants unwilling to practice adequate contraception
Agreement to use adequate contraception: women of child-bearing potential must use contraception prior to study entry and for six months after study participation; men that are sexually active whose partners are women of childbearing age must use condoms
Women of childbearing potential and male subjects must practice adequate contraception
Women of childbearing potential and male participants must practice adequate contraception throughout the study
Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment
Patients of childbearing age who are unwilling to practice contraception
Women of childbearing potential and male participants must agree to practice adequate contraception during therapy
Women of childbearing potential and male participants who are sexually active must agree to practice adequate contraception during treatment and for 6 months post-treatment
Women of childbearing potential and sexually active male participants must agree to practice adequate contraception while on study and for at least 60 days following the last dose of chemotherapy or trastuzumab
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter, which should be for at least 6 months after the completion of protocol therapy
Women of childbearing potential and male participants must agree to use an effective method of contraception
Women who are pregnant or breastfeeding or adults of reproductive potential not employing an adequate method of contraception\r\n* Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception throughout the study and for four weeks after completion of treatment or those who are using a prohibited contraceptive method
Women who are pregnant or breast feeding. Fertile patients (men and women) who are not using an effective method of contraception. All patients (men and women) must agree to use an effective contraceptive measure (if applicable) up to six months after treatment discontinuation.
Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active. This applies from the time period between signing of the informed consent until at least 6 months after the last administration of the last study drug. Male patients with a female partner of childbearing potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration.
Women of childbearing potential and men must be using an acceptable method as described in the protocol to prevent pregnancy.
Women of childbearing potential and men must agree to use adequate contraception
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.
Women of childbearing potential not using a medically acceptable means of contraception
Women of childbearing potential must implement adequate contraception in the opinion of the investigator
Patients of childbearing potential are permitted in the study so long as they consent to avoid getting their partner pregnant or becoming pregnant, respectively, by using a reliable method(s) of contraception during and for 3 months following the last dose of the study drugs
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961 (expected to be greater than 5 half-lives from pre-clinical data)
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months following last treatment
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for males at least 4 months thereafter, and for females at least 3 months thereafter
Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment.
Women of childbearing potential (WOCBP), or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial and for at least three months after the end of active therapy
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to 30 days after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Pregnant or breast-feeding women and women of childbearing age or men who are unwilling to use adequate contraception; females of childbearing age and potential (i.e., not surgically sterilized) must use a second form of contraception, including total abstinence, intra-uterine device, double-barrier contraception, or other non-hormonal form of contraception
Women of childbearing potential and men who participate in the study must agree to use adequate contraception (hormonal or barrier methods) before, during the study and for a period of 3 months after the last dose of chemotherapy
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment
Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation; adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Fertile women of childbearing potential (WCBP) not using (or refusing to use) adequate methods of contraception as agreed on between her and the consenting investigator; male participants not using (or refusing to use) a condom during intercourse
Women of childbearing potential and men must agree to use adequate contraception .
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment; adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Women of childbearing potential and male participants must use an effective contraception method; (until at least 60 days following treatment)
Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Pregnant or lactating women; women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation and up to 6 months following completion of therapy; adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Stated willingness to use contraception in women of childbearing potential.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and male participants must agree to use adequate contraception throughout the study and for up to 180 days after study treatment
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) by both sexes
Men and women of childbearing potential should practice effective methods of contraception; men and women of childbearing potential are defined as: a male that has not been surgically sterilized or female that has not been amenorrheic for at least 12 consecutive months or that has not been surgically sterilized; patients must use birth control during the study and for 3 months after the last dose of study drug if they are sexually active
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 3 months after the last dose of study drug; highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by both sexes
Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation
Males & women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for duration of study & for 6 months after last dose of study drug
Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
Women of childbearing potential must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment.
Pregnant women are excluded from this study; breastfeeding women should be excluded; women of childbearing potential and men must agree to use adequate contraception (barrier methods) before, during the study and for a period of 3 months after the last dose of the investigational agent
Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception method during treatment and for three months after completing treatment
Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women.
For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry, for the duration of study participation and for three months after completing treatment; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care
Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
Women of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and at least 3 months after the last dose of trial medication.
Women of childbearing potential and men must agree to use adequate contraception prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
Women of childbearing potential and men must agree to use adequate contraception
Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for 4 weeks after the last AGS-16C3F infusion administration
Cohort A: Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Women of childbearing potential and male participants must practice adequate contraception
Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilisation if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).
Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal)
Females of childbearing potential not using adequate contraception precautions for the duration of the study treatment and for 2 months after the last administration of investigational product.
Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant; men should be advised to not father a child while on treatment; both women of childbearing potential and men must agree to practice effective methods of contraception
Women of childbearing potential and male participants must practice adequate contraception
Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
Women of childbearing potential must agree to use effective contraceptives (as discussed with their physician) while participating in this study
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
For women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention; OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; in women of childbearing potential, effective contraception must be used for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously; If participants are interested in enrolling and have not met the requirement for contraception, they will be seen in the clinic in 1 month for re-evaluation once they have met this requirement and ensure all other eligibility criteria is met prior to dose assignment
Women with child-bearing potential who are not on hormonal contraception should be willing to use non-hormonal contraception (adequate barrier-type contraception or intrauterine device [IUD]) from the time the pregnancy test is performed for the duration of study participation, and 30 days after study drug cessation (for women of childbearing potential only)
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
Women of childbearing potential and male participants must agree to use adequate contraception for the course of the study
women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.