EUCTR2021-000179-36-IT进行中（未招募）1 期
An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies - Bintrafusp alfa Program Rollover Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MERCK KGAA
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Are = 18 years of age at the time of signing the informed consent. In Japan, if a participant is at least 18 but < 20 years of age, written informed consent from his/her parent or guardian will be required in addition to the participant’s written consent.
- •2. Are participants currently enrolled in an eligible bintrafusp alfa parent study, as indicated in the protocol, where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed and who:
- •Are currently on active bintrafusp alfa treatment (alone as a monotherapy or following discontinuation of other combination treatment agents) in the parent study and without treatment interruption at the time of rollover study enrollment, OR.
- •Experienced a confirmed CR, PR, or SD in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians OR.
- •Discontinued from bintrafusp alfa treatment in an eligible parent study due to an AE(s) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain irAEs or certain bleeding events, as described in the protocol, are excluded from participation in this Rollover study.
- •Have completed End of treatment (EoT) assessment of a parent study.
- •3. Male and Female participants must agree to use appropriate contraception and barriers, if applicable. For female participants of childbearing potential or for male participants who have female partners of childbearing potential, the following applies:
- •Participants on active treatment must agree to continue to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year; as described in the protocol) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown as described in the protocol; thus, women of childbearing potential and men must agree to use highly effective contraception as stipulated in national or local guidelines). Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 2 months (for female participants) or 4 months (for male participants) after stopping study intervention. 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.
- •4. Capable of giving signed informed consent as indicated in the protocol and to comply with the requirements and restrictions listed in the ICF and this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. Pregnancy or currently in lactation.
- •2. Known hypersensitivity to any of the study intervention ingredients.
- •3. For participants reinitiating treatment with bintrafusp alfa at study entry: have received any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa treatment.
- •4. Concurrent treatment with prohibited drugs as indicated in the protocol.
- •5. Participant has withdrawn consent from the parent study for any reason.
- •6. Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.
研究者
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