Male patients should be willing to use barrier contraception (i.e. condoms)
Male participants of childbearing potential must agree to use an adequate method of contraception during the study treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Male participants must agree to refrain from donating sperm, to abstain or use a condom during the treatment period, and at least 60 days after last dose of study drug
Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Male patients are eligible to enter and participate in the study if they are vasectomized or agree to use of contraception during the study treatment period and for at least 90 days after the last dose investigational product.
FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study
Male participants whose partners are pregnant should use condoms for the duration of the pregnancy
Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm for at least 180 days after the last dose of study treatment.
If male, must agree to use contraception and refrain from donating sperm during the treatment period and for ?120 days after last dose of study treatment.
Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
Subjects who may become pregnant or who are sexually active with a partner who could become pregnant are to use an effective form of barrier contraception during the study and for at least 60 days for female patients and 180 days for male patients after administration of study drug; and
Appropriate contraception should be used from the time of screening, throughout the duration of study participation, and for four months after the last dose of AZD1775; acceptable methods of contraception include abstinence, tubal ligation, intra-uterine devices, and vasectomized partner; all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by the male sexual partner for intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the participants treating physician should be informed immediately; additionally, male patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing AZD1775; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment
Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for 3 months after treatment stops
Male patients should be willing to use barrier contraception (i.e., condoms).
Agree to use effective contraception until 30 days following the last dose of investigational product and have a male partner who uses a condom or
For male patients who are sexually active and who are partners of premenopausal women: agreement to use two forms of contraception as in criterion 10 above during the treatment period and for at least 3 months after the last dose of study drug.
If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Male patients should be willing to use barrier contraception for the duration of the study and for 3 months after treatment discontinuation. Inclusion Criteria for Phase 1b Expansion Cohorts
Pregnancy and breast feeding are exclusion factors; enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 180 days (female patients) or 90 days (male patients) after the end of the treatment; in addition male patients must refrain from sperm donation for 90 days after the final dose of investigational product; female patients must refrain from egg cell donation for 180 days after the final dose of investigational product; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of IP.
Female subjects must not be pregnant or at risk to become pregnant during the study. Fertile male and female subjects must agree to use an effective barrier method of birth control to avoid pregnancy (for female subjects a double-barrier method of contraception, for male subjects a condom with spermicide) or total abstinence from the time of providing informed consent until 90 days after the last administration of study drug. Use of oral contraceptives is not allowed.
Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant must continue to use condoms for 7 days after stopping study medications.
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent
A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant
Male subjects must agree to use an acceptable method of contraception beginning prior to study entry, for the duration of the study, and for six months following last dose of avelumab/utomilumab
Male subjects must be willing to use barrier contraception
For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use an effective method of contraception from the start of study therapy until ?3 months after the last dose of cirmtuzumab and ?1 month after the last dose of ibrutinib, whichever is later and to refrain from sperm donation from the start of study therapy until ?3 months after administration of the final dose of either of the study drugs. Note: A male subject is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
Male Participants who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
Male participants must agree to use a contraception as detailed in protocol during the treatment period and for at least 120 days after the last dose of trial treatment and refrain from donating sperm during this period.
Male subjects must agree to practice contraception
Pregnancies\r\n* Females: females may not take part in this study if pregnant or breast-feeding for 6 months after last dose of study drug; women of child-bearing potential (WOBCP) will be asked to take a pregnancy test prior to starting study medication\r\n* Males: Male subjects should avoid fathering a child while receiving study medication and for 6 months after the last dose of study medication; males must agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication; if a female partner of a male subject taking investigational product becomes pregnant, the male subject taking the product should notify the principal investigator, and the pregnant female partner should be advised to call their healthcare provider immediately\r\n* Subjects (both males and female) should practice effective contraception during study and for 6 months after the last dose of study medication
Male subjects who are not employing an effective method of birth control from starting dose of study medications (cycle 1 day 1), including dosing interruptions through 6 months after receipt of study treatment; male subjects should agree to refrain from sperm donation while taking study treatment and for at least 6 months after the last dose of nab-paclitaxel and at least 90 days after the last dose of durvalumab; should a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study, he should inform his treating physician and the female partner should call her physician immediately
Are not currently abstinent or do not agree to refrain from sexual activity during the study period and for 6 months after study drug discontinuation;
Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug;
Male subjects capable of fathering a child must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug; male subjects will be considered to be capable of fathering a child unless they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)
Male participants who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug; sperm donation is prohibited during the study and for 30 days after the last dose of study drug; female partners must use hormonal or barrier contraception unless postmenopausal or abstinent
For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception i.e., condoms with all sexual partners
Male subjects must agree to use an acceptable method of contraception beginning prior to study entry, for the duration of the study, and for six months following duration of study participation
All patients must agree to use barrier contraception (i.e. condom) during study treatment and for 2 months after the last virus treatment and 4 months after the last dose of chemotherapy and pembrolizumab.
Subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity; OR (2) use (or have their partner use) acceptable contraception during heterosexual activity.
Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study
Male patients with a female partner of childbearing potential should agree to use a barrier method of contraception, or agree to abstain from heterosexual activity for the course of the study through 120 days after the last dose of trial treatment
Male patients must be willing to use barrier contraception (i.e., condoms) for the duration of the trial and for 6 months after trial treatment discontinuation.
Male patients on treatment with TG02 must agree to use an adequate method of contraception for the duration of the study, and for 30 days after the last dose of study medication
Male patients who are not surgically sterile unless they are using a double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug
Male subjects must agree to use effective contraception or abstinence while on study and for 90 days after infusion of the ACTolog T-cell product.
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for at least 6 months following completion of study treatment
Male patients should be willing to use barrier contraception; male patients should be asked to use barrier contraceptives (i.e., by use of condoms) during sex with all of their female partners during the trial and for a washout period of 3 months; patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing osimertinib treatment; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of osimertinib treatment
Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period
Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug
Male patients must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
A woman of child-bearing potential (WCBP) and a male patient with partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment
Male patients should be asked to avoid unprotected sex with all sexual partners but use condoms plus spermicide during the study, and for a washout period of 90 days after the last dose of study drug; where a sexual partner of a male participant is a woman of child-bearing potential, patients should avoid procreation for 90 days after completion of study drug treatment; patients should refrain from donating sperm from the start of dosing until 90 days after discontinuing study treatment; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment
Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment
Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative
Male subjects must agree to practice contraception
Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
Male subjects must agree to practice contraception
Male subjects must agree to practice contraception
Male subjects must agree to practice contraception.
Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
Male patients must be surgically sterile or use double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
Male patients should be willing to use barrier contraception
Male subjects agree to ensure that they or their female partner(s) use adequate contraception during the study and for at least 12 weeks (or longer as per local requirement) after the subject receives their last dose of study treatment.
Male patients at screening must agree to practice adequate contraception from study entry through at least 6 months after discontinuation of study drug.
Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
Male subjects must agree to refrain from sperm donation throughout the duration of the study and for 90 days following the last dose of study drug;
Male participants must agree to use contraception during the treatment period and for ?195 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom
Male patients must agree to use effective contraception or be abstinent while on study and for 90 days after the infusion of IMA202 product
Willingness of male and female patients, if sexually active, to use an effective barrier method of contraception during the study and for 3 months following the last dose of study drug
Male subjects should agree to use an adequate method of contraception during the course of the study.
Male patients must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment
Male patients unless they are using condoms as contraception starting on the day of transplantation up until one week after infusion
Male subjects must agree to practice contraception as directed
Male subjects must agree to the use of male contraception during the treatment period and for at least 180 days after the last dose of any study drug
Male subjects must agree to the use of male contraception during the treatment period and for at least 180 days after the last dose of any study drug
Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 1 month following the last study drug infusion
All sexually active subjects agree to use barrier contraception (i.e., condoms) while receiving study treatment and for 120 days following their last dose of study treatment. WOCBP and males whose sexual partners are WOCBP agree to use barrier contraception and a second form of contraception while receiving study treatment and for 120 days following their last dose of study treatment.
commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations. Male subjects must:
A man participating in this study must agree to utilize reliable barrier form of contraception for the duration of the study
Men should be willing to use barrier contraception (ie, condoms) and refrain from sperm donation during and after the conduct of the trial.
For male patients who are sexually active and who are partners of premenopausal women: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug.
Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until least 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant while on study medication must continue to use condoms for 7 days after stopping study medications.
are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexual activity during the study period and for 28 days after study drug discontinuation,
Male patients should be willing to use barrier contraception, i.e., condoms, until 3 months after last study drug is taken.
A male subject must agree to use and to have their female partners of childbearing potential to use a highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) as detailed in Appendix VII of this protocol from the first dose of study treatment, during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period. Male subjects should always use a barrier method such as condom concomitantly.
If male, patient must be sterile or willing to use an approved method of contraception from the time of Informed Consent to 90 days after study drug treatment. Males must be willing to refrain from sperm donation within 90 days after study treatment.
All participants must agree to use double barrier contraception during study participation and for at least 2 months after the last dose of study drug.
Male subjects with female partners of child bearing potential must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant on study medication must continue to use condoms for 7 days after stopping study medication
Male subjects must agree to practice contraception during the study
Male patients should be documented to be sterile or agree to use barrier contraception
Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the date of the first dose of study drug through at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Male subjects must agree to use effective contraception or abstinence while on study and for 90 days after last dose of study drug
Male patients should be willing to use barrier contraception, i.e. condoms.
Male subjects must agree to practice contraception
Patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose
Male subjects must agree to practice contraception
Male subjects must agree to practice contraception
Male participants must agree to use contraception during the treatment period and for ?180 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom
Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.
Male patients should be willing to use barrier contraception.
A patient who is sexually active and their partner must agree and use two reliable barrier forms of contraception (for example, condoms and diaphragm), from first day of study drug administration until for 1 week after last dose of abiraterone acetate, unless partner is post-menopausal
Female patients (including those < 1 year post-menopausal) and male patients who have not undergone previous surgical sterilization must agree to use contraception
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 90 days following the last study drug administration
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 90 days after the final study drug administration
You must commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption; while receiving study medication or for a longer period if required by local regulations. Male subjects must:
Male patients not willing to use a condom
Male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion if therapy.
Male subjects must agree to practice contraception
Male subjects must agree to use medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.
Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
Male subjects who are sexually active must agree to use a condom from the beginning of treatment and for 1 month after the last dose
Male subjects must agree to practice contraception
If a sexually active heterosexual male, must be agreeable to practicing 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment
Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation
For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
Male patients are to agree to use a barrier method of contraception from study treatment initiation until at least 90 days after the last administration of Folotyn
Male participants must agree to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of treatment
Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
All female subjects of child bearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Adequate contraception for both male and female subjects must be used from the beginning of the screening period until at least 8 weeks after the last dose of study drug.