Avelumab Program Rollover Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Avelumab

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
    • Instituto Alexander Fleming
  • Córdoba, Argentina
    • Clínica Universitaria Privada Reina Fabiola
• Australia
  • Ballarat, Australia
    • Ballarat Health Services
  • Clayton, Australia
    • Monash Medical Centre Clayton
• Belgium
  • Libramont, Belgium
    • Centre Hospitalier de l'Ardenne - Pharmacie
  • Liège, Belgium
    • Clinique CHC MontLégia
• Brazil
  • Barretos, Brazil
    • Hospital de Cancer de Barretos - Fundacao Pio XII
• Bulgaria
  • Sofia, Bulgaria
    • MHAT for women's health - Nadezhda, OOD
• Czechia
  • Benešov, Czechia
    • Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
  • Brno, Czechia
    • Masarykuv onkologicky ustav - 300176866 Parent
• France
  • Besançon, France
    • CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
  • Lille, France
    • Centre Oscar Lambret - Service d'Oncologie medicale
  • Nantes, France
    • ICO - Site Paul Papin - service d'oncologie medicale
  • Nantes, France
    • ICO - Site René Gauducheau - Service d'Oncologie medicale
  • Nice, France
    • Centre Antoine Lacassagne - Service d'Hématologie Oncologie
  • Paris, France
    • Institut Curie - site de Paris - Service d'Oncologie Médicale
  • Pessac, France
    • CHU Bordeaux - Service d'Oncologie Médicale
  • Pessac, France
    • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
  • Poitiers, France
    • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
  • Strasbourg, France
    • Centre Paul Strauss - Service de Médecine Oncologique
  • Toulouse, France
    • Hopital Larrey - Service de Pneumologie et Oncologie Thoracique
• Germany
  • Essen, Germany
    • Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
• Hungary
  • Győr, Hungary
    • Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
  • Zalaegerszeg, Hungary
    • Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly
• Italy
  • Naples, Italy
    • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
  • Padua, Italy
    • Iov - Istituto Oncologico Veneto Irccs
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
  • Roma, Italy
    • Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
  • Rozzano, Italy
    • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
• Japan
  • Chūōku, Japan
    • National Cancer Center Hospital (NCCH)
  • Chūōku, Japan
    • National Cancer Center Hospital - Dept of Gastrointestinal Oncology
  • Habikino-shi, Japan
    • Osaka Habikino Medical Center - Dept of Pulmonary Oncology
  • Kurume-shi, Japan
    • Kurume University Hospital - Dept of Lung Cancer Center
  • Kōtoku, Japan
    • Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
  • Osaka, Japan
    • Osaka City General Hospital - Dept of Clinical Oncology
  • Sendai, Japan
    • Tohoku University Hospital
  • Suita-shi, Japan
    • Osaka University Hospital - Dept of Gastrointestinal Surgery
• Mexico
  • México, Mexico
    • Health Pharma Professional Research S.A. de C.V.
• Poland
  • Warsaw, Poland
    • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
• Romania
  • Cluj-Napoca, Romania
    • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
  • Comuna Floresti, Romania
    • S.C Radiotherapy Center Cluj S.R.L - Parent
  • Iași, Romania
    • Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
  • Oradea, Romania
    • Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
  • Timișoara, Romania
    • S.C Oncomed S.R.L - Specialitatea Oncologie Medicala
• Russia
  • Kursk, Russia
    • RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
  • Novosibirsk, Russia
    • SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
  • Omsk, Russia
    • BHI of Omsk region "Clinical Oncology Dispensary" - Building #2
  • Saint Petersburg, Russia
    • FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent
  • Saint Petersburg, Russia
    • LLC "Medical Technologies" - Parent
  • Saint Petersburg, Russia
    • Pavlov First Saint Petersburg State Medical University - PARENT
• South Korea
  • Cheongju-si, South Korea
    • Chungbuk National University Hospital
  • Daejeon, South Korea
    • Chonnam National University Hwasun Hospital
  • Goyang, South Korea
    • National Cancer Center
  • Incheon, South Korea
    • Gachon University Gil Medical Center
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Korea University Anam Hospital
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Seoul National University Hospital
  • Seoul, South Korea
    • The Catholic University of Korea, Seoul St. Mary's Hospital
• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau - Dept of Oncology
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron - Oncology Dept.
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
  • Mataró, Spain
    • Hospital de Mataro - Servicio de Oncologia Medica
• Thailand
  • Songkhla, Thailand
    • Songklanagarind Hospital - Department of Medicine
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Adana City Hospital - Parent Account
  • Ankara, Turkey (Türkiye)
    • Ankara University Medical Faculty - Medical Oncology
  • Ankara, Turkey (Türkiye)
    • Hacettepe University Medical Faculty - Oncology
  • Istanbul, Turkey (Türkiye)
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
  • Istanbul, Turkey (Türkiye)
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology
  • Istanbul, Turkey (Türkiye)
    • Medipol University Medical Faculty - Parent
  • Izmir, Turkey (Türkiye)
    • Ege University Medical Faculty - PARENT
  • Mersin, Turkey (Türkiye)
    • Mersin University Medical Faculty - Medical Oncology
• Ukraine
  • Kherson, Ukraine
    • CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
  • Vinnytsia, Ukraine
    • Podilskyi Regional Oncological Center - Dept of Chemotherapy
  • Vinnytsia, Ukraine, 21029
    • BP Medical
• United Kingdom
  • London, United Kingdom
    • Sarah Cannon Research Institute UK
  • Northwood, United Kingdom
    • Mount Vernon Cancer Centre
  • Plymouth, United Kingdom
    • Derriford Hospital - Dept of Oncology Clinical Trials
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Honorhealth Research Institute
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Health System - Comprehensive Cancer Center
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Norwalk Hospital - The Whittingham Cancer Center
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology, P.A.
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Michigan State University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute, LLC - Phase I Unit
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati - PARENT
    • Cincinnati, Ohio, United States, 45242
      • Oncology/Hematology Care Clinical Trials, Llc
    • Columbus, Ohio, United States, 43210-1228
      • OSU - James Comprehensive Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic
    • Nashville, Tennessee, United States, 37203
      • SCRI - Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390-8857
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Oncology Consultants, P.A.
    • San Antonio, Texas, United States, 78229
      • Henry Ford Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center - Fletcher Allen Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avelumab	Drug: Avelumab; Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).; Other Names: MSB0010718C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Overall Survival (OS)	From baseline up to 5 years
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

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• US Medical Information website, Medical Resources
• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Avelumab; Ovarian cancer; Non-small cell lung cancer (NSCLC); Renal cell carcinoma (RCC); Urothelial carcinoma (UC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Neoplasms by Histologic Type; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Ovarian Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; avelumab
• Other Study ID Numbers: MS100070_0176; 2018-003711-21 (EudraCT Number); 2024-514274-46-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
• IPD Sharing Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• IPD Sharing Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No