Avelumab for Cancer

Recruiting at 105 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: EMD Serono Research & Development Institute, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main purpose of this study is 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.

Research Team

Medical Responsible

Principal Investigator

Merck KGaA, Darmstadt, Germany

Eligibility Criteria

This trial is for patients with solid tumors who are already enrolled in an avelumab study and either continue treatment or are in follow-up. They must use effective contraception if applicable, not have allergies to the drug's ingredients, and cannot be pregnant or breastfeeding.

Inclusion Criteria

My treatment is associated with Merck Serono in Japan.

Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists

I meet other specific requirements for the trial.

Exclusion Criteria

Participants who are pregnant or breastfeeding

Participant has been enrolled in the comparator arm of avelumab parent study

I am allergic to one or more ingredients in the study treatment.

Treatment Details

Interventions

• Avelumab (Monoclonal Antibodies)

Trial Overview The trial monitors the ongoing safety and tolerability of avelumab, a medication previously studied for treating solid tumors. Participants will maintain their current regimen from the parent study without any changes.

Participant Groups

Group I: Avelumab Experimental Treatment 1 Intervention

Avelumab is already approved in Japan for the following indications:

Approved in Japan as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials

449

Recruited

122,000+

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD