Authorised Therapeutic confirmatory (Phase III) Solid Tumors

Avelumab Program Rollover Study

EU CTIS ID: 2024-514274-46-00

What this study is testing

To monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participants are ≥ 18 years of age at the time of signing the informed consent.
  • Participants are under enrollment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA / Merck Serono Co., Ltd (Japan).
  • Participants currently enrolled in an avelumab parent study where the primary/main analysis has been completed and who are: • Currently on active avelumab treatment in any parent study, regardless of indication, OR • In long-term survival follow-up after treatment (participants in Non-Small Cell Lung Cancer [NSCLC], Renal Cell Carcinoma [RCC], Urothelial Carcinoma [UC], and ovarian cancer indications only), OR • Who experienced CR in the parent study and discontinued avelumab treatment according to the parent study protocol.
  • Participants are male or female. Participants on active treatment must agree to continue to use highly effective contraception (ie, methods with a failure rate of less than 1% per year) 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; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix 3 (Contraception) or 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 60 days 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).
  • Participants can give signed informed consent, as indicated in Appendix 2 (Study Governance), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

You likely can't join if

  • Participants are pregnant or breastfeeding.
  • For participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients.
  • Participant has been enrolled in the comparator arm of avelumab parent study.
  • Participant has been withdrawn from avelumab parent study for any reason (Note: Participants in the Follow-up Period are eligible).
  • Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.

The study team makes the final eligibility decision.

Where it's taking place

  • Korea, Republic of
  • Ukraine
  • Japan
  • Argentina
  • Turkey
  • Mexico
  • Brazil
  • United States
  • Russian Federation
  • Thailand

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Korea, Republic of; Ukraine; Japan; Argentina; Turkey; Mexico and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.