Avelumab Program Rollover Study
Running, not enrolling · Phase 3
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT03815643
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 205
- Starts
- 2019-03-22
- Expected to finish
- 2026-08-21
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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- Participant has been withdrawn from avelumab parent study for any reason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.
Where it is running
- 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
- Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
- Kansas City Research Institute, LLC - Phase I Unit — Kansas City, Missouri, United States
- University of Cincinnati - PARENT — Cincinnati, Ohio, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- Oncology/Hematology Care Clinical Trials, LLC — Cincinnati, Ohio, United States
- OSU - James Comprehensive Cancer Center — Columbus, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
- Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization — Greenville, South Carolina, United States
- The West Clinic — Germantown, Tennessee, United States
- SCRI - Tennessee Oncology — Nashville, Tennessee, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Oncology Consultants, P.A. — Houston, Texas, United States
- Henry Ford Hospital — San Antonio, Texas, United States
- HonorHealth Research Institute — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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