Avelumab Program Rollover Study
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
3 other identifiers
interventional
205
22 countries
104
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 parent avelumab study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
Longer than P75 for phase_3
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedStudy Start
First participant enrolled
March 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 21, 2026
March 31, 2026
March 1, 2026
7.4 years
January 22, 2019
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (1)
Avelumab
EXPERIMENTALInterventions
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).
Eligibility Criteria
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
University of California Davis Health System - Comprehensive Cancer Center
Sacramento, California, 95817, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
St Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Norwalk Hospital - The Whittingham Cancer Center
Norwalk, Connecticut, 06850, United States
Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Michigan State University
Lansing, Michigan, 48910, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Kansas City Research Institute, LLC - Phase I Unit
Kansas City, Missouri, 64131, United States
University of Cincinnati - PARENT
Cincinnati, Ohio, 45229, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Oncology/Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242, United States
OSU - James Comprehensive Cancer Center
Columbus, Ohio, 43210-1228, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization
Greenville, South Carolina, 29605, United States
The West Clinic
Germantown, Tennessee, 38138, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8857, United States
Oncology Consultants, P.A.
Houston, Texas, 77030, United States
Henry Ford Hospital
San Antonio, Texas, 78229, United States
University of Vermont Medical Center - Fletcher Allen Gastroenterology
Burlington, Vermont, 05401, United States
Instituto Alexander Fleming
Ciudad Autonoma Buenos Aires, Argentina
Clínica Universitaria Privada Reina Fabiola
Córdoba, Argentina
Ballarat Health Services
Ballarat, Australia
Monash Medical Centre Clayton
Clayton, Australia
Centre Hospitalier de l'Ardenne - Pharmacie
Libramont, Belgium
Clinique CHC MontLégia
Liège, Belgium
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, Brazil
MHAT for women's health - Nadezhda, OOD
Sofia, Bulgaria
Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
Benešov, Czechia
Masarykuv onkologicky ustav - 300176866 Parent
Brno, Czechia
CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
Besançon, France
Centre Oscar Lambret - Service d'Oncologie medicale
Lille, France
ICO - Site Paul Papin - service d'oncologie medicale
Nantes, France
ICO - Site René Gauducheau - Service d'Oncologie medicale
Nantes, France
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice, France
Institut Curie - site de Paris - Service d'Oncologie Médicale
Paris, France
CHU Bordeaux - Service d'Oncologie Médicale
Pessac, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
Pessac, France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers, France
Centre Paul Strauss - Service de Médecine Oncologique
Strasbourg, France
Hopital Larrey - Service de Pneumologie et Oncologie Thoracique
Toulouse, France
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
Essen, Germany
Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
Győr, Hungary
Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly
Zalaegerszeg, Hungary
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
Naples, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, Italy
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
Roma, Italy
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Rozzano, Italy
National Cancer Center Hospital (NCCH)
Chūōku, Japan
National Cancer Center Hospital - Dept of Gastrointestinal Oncology
Chūōku, Japan
Osaka Habikino Medical Center - Dept of Pulmonary Oncology
Habikino-shi, Japan
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
Kōtoku, Japan
Kurume University Hospital - Dept of Lung Cancer Center
Kurume-shi, Japan
Osaka City General Hospital - Dept of Clinical Oncology
Osaka, Japan
Tohoku University Hospital
Sendai, Japan
Osaka University Hospital - Dept of Gastrointestinal Surgery
Suita-shi, Japan
Health Pharma Professional Research S.A. de C.V.
México, Mexico
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
Warsaw, Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
Cluj-Napoca, Romania
S.C Radiotherapy Center Cluj S.R.L - Parent
Comuna Floresti, Romania
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
Iași, Romania
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
Oradea, Romania
S.C Oncomed S.R.L - Specialitatea Oncologie Medicala
Timișoara, Romania
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
Kursk, Russia
SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
Novosibirsk, Russia
BHI of Omsk region "Clinical Oncology Dispensary" - Building #2
Omsk, 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
Saint Petersburg, Russia
Chungbuk National University Hospital
Cheongju-si, South Korea
Chonnam National University Hwasun Hospital
Daejeon, South Korea
National Cancer Center
Goyang, South Korea
Gachon University Gil Medical Center
Incheon, 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
Seoul, South Korea
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona, Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, Spain
Hospital de Mataro - Servicio de Oncologia Medica
Mataró, Spain
Songklanagarind Hospital - Department of Medicine
Songkhla, Thailand
Adana City Hospital - Parent Account
Adana, Turkey (Türkiye)
Ankara University Medical Faculty - Medical Oncology
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty - Oncology
Ankara, 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
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty - PARENT
Izmir, Turkey (Türkiye)
Mersin University Medical Faculty - Medical Oncology
Mersin, Turkey (Türkiye)
CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
Kherson, Ukraine
BP Medical
Vinnytsia, 21029, Ukraine
Podilskyi Regional Oncological Center - Dept of Chemotherapy
Vinnytsia, Ukraine
Sarah Cannon Research Institute UK
London, United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom
Derriford Hospital - Dept of Oncology Clinical Trials
Plymouth, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 24, 2019
Study Start
March 22, 2019
Primary Completion (Estimated)
August 21, 2026
Study Completion (Estimated)
August 21, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- 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
- 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.
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