Patients of childbearing potential must agree to use an effective form of contraception during this study and for 90 days following the last dose of chemotherapy; an effective form of contraception is an oral contraceptive or a double barrier method
Patients must agree to use effective means of contraception (for treatment phase)
Subjects must use effective contraception.
Agreement to use effective methods of contraception per the protocol requirements
Male subjects who are unwilling to use acceptable method of effective contraception.
Using an effective means of contraception that is planned to continue for the duration of treatment and for a further 3 months.
Agree to use an effective means of contraception (per site-specific guidelines) that is planned to continue until 6 months after the last dose of OPN-305.
Agree to practice effective contraception
Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment.
Refusal to use effective methods of contraception (see inclusion criteria for details).
Willingness to use effective contraception.
Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.
Pregnant or nursing (fertile patients must use effective contraception during and for up to 3 months after completion of study treatment)
Willingness to use contraception by a method that is deemed effective by the investigator throughout the treatment period and for at least 30 days following the last dose of therapy
Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal,or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
For patients post pubertal: Female patients must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
Males and females not willing to use effective contraception.
If male, must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of study treatment.
Pregnancy or breastfeeding - Female patients must be surgically sterile (i.e., ?6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) or be postmenopausal, or must agree to use effective contraception during the study and for 3 months following last dose of carotuximab (TRC105). All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to study treatment. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 3 months following last dose of carotuximab (TRC105). The definition of effective contraception is provided in Section 2.6.1 of this protocol.
Agreement on the part of any male participant to use effective contraception during sexual activity throughout the duration of treatment and for 2 months after discontinuation, for protection against the risk of embryofetal toxicity
Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment
Effective contraception if the risk of conception exists.
The subject must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of their participation in the study
Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment.
Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment; male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment; the decision of effective contraception will be based on the judgment of the principal investigator or a designated associate
Agree to practice effective contraception
Willing to use effective contraception for at least 28-days post study drug administration.
Be a pregnant or breast-feeding woman; female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal; male patients must agree to use effective contraception or be surgically sterile; barrier methods are a recommended form of contraception
Patients of childbearing potential must agree to abstinence or the use of effective contraception
Pregnancy or breast-feeding; female patients must be surgically sterile or be post-menopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male patients must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
Females > 13 years of age or who have achieved menarche must have a negative pregnancy test within 2 weeks of starting treatment (urine or serum) to be eligible and if sexually active must also agree to use contraception; male sexually active patients must agree to use an effective method of contraception
Patients of childbearing potential must agree to use effective contraception until at least 6 months after treatment with dabrafenib and trametinib
Subjects must agree to use effective means to prevent conception from enrollment through completion of the study
Effective contraception is required while receiving ibrutinib in combination with GA101 - obinutuzumab; for women of childbearing potential and men, effective contraception is required while receiving GA101 – obinutuzumab and for 365 days (12 months) after the last dose of the study drug
Willingness to use effective and reliable methods of contraception
Men or women not using effective contraception
Patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter; the definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate
Agrees to protocol-defined use of effective contraception
Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;
Fertile patients must use effective contraception
FCBP who are unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec
Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment
The subject must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of their participation in the study
Subjects must agree to use effective contraception from enrollment through completion of the study
If sexually active, willingness to use effective barrier or medical contraception
Patients who do not agree to practice effective forms of contraception
Pregnant or lactating; patients of childbearing potential must use an effective method of contraception
ECOG performance status of 0 to 1 • In sexually-active patients, willingness to use 2 effective methods of contraception
Participants must agree to be willing to use effective methods of contraception as defined in the protocol
Documented willingness to use an effective means of contraception for both men and women while participating in the study
Pregnancy or breast-feeding; patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the MSKCC and participating site principal investigator (PI); male patients must be surgically sterile or agree to use effective contraception
Agrees to protocol-defined use of effective contraception
Effective contraception
Subjects must use effective contraception:
Pregnancy or breastfeeding. Female patients must be surgically sterile (i.e.: hysterectomy) or be postmenopausal, or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to first dose. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate.
Patients must be willing to practice effective contraception for the duration of the study
Effective contraception as defined by protocol
Pregnancy, lactation, or breast-feeding; patients must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy and for 5 months after the last dose of atezolizumab; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate; male patients must be surgically sterile or agree to use effective contraception; male patients will be encouraged to notify the study team if their female partner becomes pregnant while on study
Subject is using effective contraception.
Pregnancy or breastfeeding; female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; all female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment; male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab; for men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment
Effective contraception is required while receiving GA101 - obinutuzumab; for women of childbearing potential and men, effective contraception is required while receiving GA101 – obinutuzumab and for 365 days (12 months) after the last dose of the study drug
Fertile subjects must use effective contraception during the course of the study and for 30 days following withdrawal from the study;
Concurrent oral contraceptives/ Fertile patients must use effective barrier contraception;
Agrees to protocol-defined use of effective contraception
All subjects must agree to use effective means of contraception with their partner from entry into the trial through 6 months after the last dose of avelumab
Pregnancy or breast feeding; patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgement of the principal investigator or a designated associate; male patients must be surgically sterile or agree to effective contraception; female patients of child bearing potential (ages 11-55) must have a negative beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 14 days prior to registration
Agrees to protocol-defined use of effective contraception
Pregnancy or breast-feeding; patients must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate; male patients must be surgically sterile or agree to use effective contraception
Men must agree to use effective contraception during treatment and for at least 1 week after the last administration of therapy
Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-302
Agree to use effective form of contraception (as applicable)
Fertile patients must use effective contraception
Pregnant or lactating; patients of childbearing potential must use an effective method of contraception
Inclusion Criteria:\n\n          -  The subject must have already received CP-675,206 in another protocol\n\n          -  Females of childbearing potential must agree to practice a form of effective\n             contraception for 12 months following any dose of study drug. The definition of\n             effective contraception will be based on the judgement of the investigator.\n\n          -  Subject must be willing and able to provide written informed consent and to comply\n             with scheduled visits and other trial procedures\n\n        Exclusion Criteria:
Willingness to use effective contraception.
Patients who cannot or do not intend to practice effective contraception
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab; for men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment
Agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy and for two (2) months following the last dose of panitumumab; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate; male patients must be surgically sterile or agree to use effective contraception
Men not willing to use an effective contraception method while on study
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab; for men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment
Use of effective contraception
Participants of childbearing age must use effective contraception
Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
Patient must consent to using effective contraception while on treatment and for 3 months thereafter
Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial and should continue use for 4 months after last dose of study drug
Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
Males, unless surgically sterile, must use 2 effective methods of contraception with a female partner and must agree to continue using such contraception for 90 days after the last dose of MEDI0639
Use of two effective forms of contraception
Fertile Participants must use 2 effective methods of contraception prior to and through 6 months after the last dose of the study drug
Documented willingness to use an effective means of contraception
Males who do not agree to use effective contraception during the study and for a period of 60 days following the final dose of study agent.
If sexually active, must be post-menopausal, surgically sterile, or using effective contraception; and agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication
Agreement to use an effective form of contraception for the duration of the study
Fertile patients must use effective contraception
Male subjects must be surgically sterile or agree to use effective contraception starting at the first dose of chemotherapy and for 4 months thereafter (if indicated in the country specific monograph/label for cyclophosphamide).
Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of GC4419
Females who are sexually active without use of effective contraception
Fertile patients must use effective contraception
Participants must agree to use effective contraception
Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. Note: Acceptable methods of effective contraception are defined in the informed consent/assent form. Where required by local laws and regulations, additional country-specific contraception requirements may be outlined in a country-specific protocol supplement at the end of the Appendix Section of protocol.
Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study