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ACTIVE_NOT_RECRUITINGPHASE3

Avelumab Program Rollover Study

An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

NCT03815643•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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•Participant has been withdrawn from avelumab parent study for any reason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

Locations (104)

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

Key Dates

Start Date

March 22, 2019

Primary Completion Date

February 19, 2027

Completion Date

February 19, 2027

Last Updated

December 4, 2025

Enrollment

205

ACTUAL participants

Conditions

Solid Tumors

Interventions

Avelumab

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Avelumab Program Rollover Study

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors