Status:
ACTIVE_NOT_RECRUITING
Avelumab Program Rollover Study
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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- Participant has been withdrawn from avelumab parent study for any reason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.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2027
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03815643
Start Date
March 22 2019
End Date
February 19 2027
Last Update
December 4 2025
Active Locations (104)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
3
University of California Davis Health System - Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Providence Medical Foundation
Santa Rosa, California, United States, 95403