Avelumab Program Rollover Study

Sponsor: EMD Serono Research & Development Institute, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT03815643

This study monitors the safety and tolerability of avelumab in participants with solid tumors from previous avelumab studies. Eligible participants must be actively enrolled in an avelumab study by EMD Serono/Merck KGaA and agree to use effective contraception. Participants will receive avelumab via IV infusion every 2 weeks until disease progression, following their respective parent study protocols.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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  • Participant has been withdrawn from avelumab parent study for any reason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.

Locations

FACILITYZIPCITYSTATE
HonorHealth Research Institute85258ScottsdaleArizona
Highlands Oncology Group72703FayettevilleArkansas
University of California Davis Health System - Comprehensive Cancer Center95817SacramentoCalifornia
Providence Medical Foundation95403Santa RosaCalifornia
St Joseph Heritage Healthcare95403Santa RosaCalifornia
Norwalk Hospital - The Whittingham Cancer Center06850NorwalkConnecticut
Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast34952Port Saint LucieFlorida
Northwest Georgia Oncology Centers30060MariettaGeorgia
Maryland Oncology Hematology, P.A.20850RockvilleMaryland
Michigan State University48910LansingMichigan

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