Avelumab Program Rollover Study

Phase 3

Active, not recruiting

• Conditions: Solid Tumors
• Interventions: Drug: Avelumab

• Registration Number: NCT03815643
• Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-24
• Study Start: 2019-03-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-02-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany

  • Merck Serono Co., Ltd (Japan)

• Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment

• 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

• Other protocol defined inclusion criteria could apply.

Exclusion Criteria

• Participants who are pregnant or breastfeeding
• 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• Participant has been withdrawn from avelumab parent study for any reason
• Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
• Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avelumab	Avelumab	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events	From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	From baseline up to 5 years
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)	From baseline up to 5 years
Overall Survival (OS)	From baseline up to 5 years

Trial Locations

Locations (103)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Highlands Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States

University of California Davis Health System - Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

Providence Medical Foundation; 🇺🇸 Santa Rosa, California, United States

St Joseph Heritage Healthcare; 🇺🇸 Santa Rosa, California, United States

Norwalk Hospital - The Whittingham Cancer Center; 🇺🇸 Norwalk, Connecticut, United States

Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast; 🇺🇸 Port Saint Lucie, Florida, United States

Northwest Georgia Oncology Centers; 🇺🇸 Marietta, Georgia, United States

Maryland Oncology Hematology, P.A.; 🇺🇸 Rockville, Maryland, United States

Michigan State University; 🇺🇸 Lansing, Michigan, United States

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