[c09aa8]: / clusters / 9knumclustersv2 / clust_347.txt

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Patients must agree to use effective means of contraception (for treatment phase)
Both male and female subjects must be willing to use highly effective contraception (that is, methods with a failure rate of less than % per year) throughout the study and for at least days after last avelumab treatment administration if the risk of conception exists\r\n* (NOTE: Women of childbearing potential and men must agree to use highly effective contraception, as stipulated in national or local guidelines; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately)
Highly effective contraception (i.e., methods with a failure rate of less than % per year) for both male and female subjects if the risk of conception exists (Note: The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Protocol Appendix ., or as stipulated in national or local guidelines. Highly effective contraception must be used for the duration of trial treatment, and at least for days after stopping trial treatment or months after stopping chemotherapy [or per label]. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately).
Subjects must use effective contraception.
Agreement to use effective methods of contraception per the protocol requirements
Patients with reproductive potential (male/female) must agree to use accepted and highly effective methods of contraception while receiving study therapy and for at least months after the completion of study therapy. The definition of effective method of contraception will be based on the investigator's discretion.
Using an effective means of contraception that is planned to continue for the duration of treatment and for a further months.
Agree to use an effective means of contraception (per site-specific guidelines) that is planned to continue until months after the last dose of OPN-.
Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.)
Willingness to use effective contraception.
Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used days prior to first trial administration, for the duration of trial treatment, and at least for months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
Willingness to use contraception by a method that is deemed effective by the investigator throughout the treatment period and for at least days following the last dose of therapy
Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used days prior to first trial administration, for the duration of trial treatment, and at least for months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
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 weeks following the last dose of study treatment.
Highly effective contraception for both male and female subjects throughout the study and for at least days after last avelumab treatment administration if the risk of conception exists
Highly effective contraception for male subjects with childbearing potential throughout the study and for at least days after last avelumab treatment administration if the risk of conception exists
Highly effective contraception for both male and female subjects if the risk of conception exists; Note: women of childbearing potential and men able to father a child must agree to use highly effective contraception, defined as methods with a failure rate of less than % per year; highly effective contraception is required at least days prior, throughout and for at least days after avelumab treatment
Agreement on the part of any male participant to use effective contraception during sexual activity throughout the duration of treatment and for months after discontinuation, for protection against the risk of embryofetal toxicity
Contraception should be continued using two highly effective methods for a period of days
Effective contraception if the risk of conception exists.
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: women of childbearing potential and men must agree to use highly effective contraception, defined as barrier methods, or barrier method with a spermicide, an intrauterine device or use of oral female contraceptive; effective contraception must be used days prior to first study drug administration, for the duration of trial participation, and at least for days after last avelumab treatment administration if the risk of conception exists; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately)\r\n* Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: the effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use highly effective contraception, defined as methods with a failure rate of less than % per year; highly effective contraception is required at least days prior, throughout and for at least days after avelumab treatment
Must agree to the use of effective contraception while on study treatment, unless they are highly unlikely to conceive (defined as [] surgically sterilized, or [] postmenopausal [i.e., a woman who is > years old or who has not had menses for >= year], or [] not heterosexually active for the duration of the study)
Patients may be pre- or post-menopausal; pre-menopausal patients must be on ovarian suppression and must be adequately suppressed on luteinizing hormone-releasing hormone (LHRH) agonists with estradiol levels in the post-menopausal range\r\n* Premenopausal patients cannot be pregnant and must agree to adequate birth control in addition to ovarian suppression; agreement by the patient and/or partner to use highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception; contraception use should continue during the duration of study treatment and for at least months after the last dose of study treatment
Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to months after the last administered dose; the definition of effective method of contraception will be based on the investigators judgment
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 GA - obinutuzumab; for women of childbearing potential and men, effective contraception is required while receiving GA obinutuzumab and for days ( months) after the last dose of the study drug
Women of child-bearing potential, who are biologically able to conceive, not employing forms of highly effective contraception; male not using at least at least one form of highly effective contraception will be excluded; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for months after the end of study treatment; oral, implantable, or injectable contraceptives may be affected by cytochrome P interactions, and are therefore not considered effective for this study
Willingness to use effective and reliable methods of contraception
Men or women not using effective contraception
Both male and female patients must be willing to consent to using highly effective contraception prior to study entry, while on treatment and at least months thereafter.
Highly effective contraception
Consent to use one highly effective method of contraception
WOCBP or males with a WOCB partners not willing to use highly effective and medically accepted methods of contraception for days after last study drug administration.
Agrees to protocol-defined use of effective contraception
Non-childbearing potential (defined as surgically sterile or at least years postmenopausal) or practicing effective contraception (defined as concurrent methods of contraception, of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;
Patients who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol
Subjects must agree to use effective contraception from enrollment through completion of the study
Highly effective contraception for both male and female subjects if the risk of conception exists
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment
? years of age . Life expectancy of ? months per the investigator . Eastern Cooperative Oncology Group (ECOG) performance status of or . ECG without evidence of clinically significant arrhythmia or ischemia . If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last CMB injection . If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last CMB injection
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
If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last LV injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for days after last injection of study drug.
Agrees to protocol-defined use of effective contraception
Use of highly effective method of contraception as defined by the protocol
Highly effective contraception for both male and female subjects, if the risk of conception exists
Effective contraception
Subjects must use effective contraception:
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception. During the study treatment and for weeks after stopping the treatment. Highly effective contraception methods include combination of any two of the following:
Effective contraception as defined by protocol
Use of highly effective contraception as defined by the study protocol
Subjects must agree to consistently use forms of highly effective contraception/birth control between signing of the informed consent and days after the last study drug administration.
Effective contraception for both male and female subjects if the risk of conception exists
Subject is using effective contraception.
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= months after the last dose of obinutuzumab; for men, effective contraception is required to continue for months after the last dose of obinutuzumab treatment
Effective contraception is required while receiving GA - obinutuzumab; for women of childbearing potential and men, effective contraception is required while receiving GA obinutuzumab and for days ( months) after the last dose of the study drug
Patients must agree to use highly effective contraception (details outlined in the consent form) during treatment and for a period of days after ending treatment with palbociclib
Use of highly effective contraception
Agrees to protocol-defined use of effective contraception
Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for months after the last dose of study treatment
Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:
Female patients of childbearing potential (a female not free from menses > years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study; highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device; highly effective contraception must be used by both sexes during the study and must be continued for months after the last dose of denosumab
All subjects must agree to use effective means of contraception with their partner from entry into the trial through months after the last dose of avelumab
Agrees to protocol-defined use of effective contraception
Men must agree to use effective contraception during treatment and for at least week after the last administration of therapy
Agree to use effective form of contraception (as applicable)
Effective contraception for both male and female subjects if risk of conception exists.
Effective contraception for female subjects if risk of conception exists. Note: Effects of the study drug on the developing human fetus are unknown. Thus, women of childbearing potential and men must agree to use effective contraception, defined as barrier methods, or barrier method with a spermicide, an intrauterine device or use of oral female contraceptive. Effective contraception must be used days before first study drug administration, for the duration of trial participation, and ? days after stopping trial participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
Inclusion Criteria:\n\n - The subject must have already received CP-, in another protocol\n\n - Females of childbearing potential must agree to practice a form of effective\n contraception for 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:
For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception during and for at least months after completion of study treatment; OR, a fertile male partner willing and able to use effective non-hormonal of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least months after completion of study treatment
Willingness to use effective contraception.
Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used).
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= months after the last dose of obinutuzumab; for men, effective contraception is required to continue for months after the last dose of obinutuzumab treatment
Agreement to use effective contraception while on treatment and for at least months after end of treatment
Effective contraception is required while receiving obinutuzumab; for women, effective contraception is required to continue for >= months after the last dose of obinutuzumab; for men, effective contraception is required to continue for months after the last dose of obinutuzumab treatment
Patient who does not apply highly effective contraception during the study from screening until days after discontinuing study treatment Protocol No. PQR- Protocol Amendment , September PIQUR Therapeutics AG - Confidential Page of (see section .).
Highly effective contraception as defined by the protocol Participants with Ovarian Cancer
Women of child-bearing potential are required to use effective contraception throughout the study period. Effective contraception methods include:
Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to months after the last administered dose. The definition of \effective method of contraception\ will be based on the Investigator's judgment.
Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and days after the last administration of study drug. Highly effective contraception includes a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of the partner. In addition, the use of condoms for subjects or their partners is required.
Men unable or unwilling to employ forms of highly effective contraception throughout the study and for weeks after the end of study treatment
Use of effective contraception
Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= months after the last dose of obinutuzumab. For men, effective contraception is required to continue for months after the last dose of chlorambucil treatment.
Use of highly effective form of contraception
Patient must consent to using effective contraception while on treatment and for months thereafter
Patient who does not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
Use of two effective forms of contraception
All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation greater than or equal to menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy). Female subjects of child-bearing potential must agree to use two forms of highly effective contraception from the last menstrual period prior to randomization (or use a double barrier method as described below until they are on two forms of highly effective contraception for at least one menstrual cycle), during the study treatment, and for months after the final dose of study treatment. Female subjects exempt from this requirement are subjects who practice total abstinence. If currently abstinent, the subject must agree to use a double barrier method of contraception, i.e., condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide or until they are on two forms of highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for months after the final dose of study treatment. Highly effective contraception includes:
Male subjects and their female partner who are of child-bearing potential (as defined in Inclusion ), and are not practicing total abstinence, must agree to use two forms of highly effective contraception from the last menstrual period of their female partner prior to randomization (or use a double barrier method as described above until they are on two forms of highly effective contraception for at least one menstrual cycle), during study treatment, and for months (or months if they received dacarbazine) after the final dose of study treatment. If currently abstinent, must agree to use a double barrier method of contraception if they become sexually active, or until they are on two forms of highly effective contraception as described above.
Documented willingness to use an effective means of contraception
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 months after the last dose of study medication
Agreement to use an effective form of contraception for the duration of the study
All subjects, except post-menopausal women, must be willing to utilize a highly effective method of contraception throughout the study
Participants must agree to use effective contraception
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: women of childbearing potential and men able to father a child must agree to use methods of highly effective contraception, defined as methods with a failure rate of less than % per year; highly effective contraception is required at least days prior, throughout and for at least and months following the last dose of trabectedin)
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 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.
Sexually active women and men of reproductive potential must agree to use highly effective contraception. This applies for the period between signing of the informed consent and months after the last administration of study drug. These procedures should be documented in source documents. The investigator or a designated associate is requested to advise the patient on how to achieve highly effective birth control. Highly effective contraception includes: