Avelumab Program Rollover Study

NCT ID: NCT03815643

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2027-02-19

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avelumab

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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MSB0010718C

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

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HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status

Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

University of California Davis Health System - Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Providence Medical Foundation

Santa Rosa, California, United States

Site Status

St Joseph Heritage Healthcare

Santa Rosa, California, United States

Site Status

Norwalk Hospital - The Whittingham Cancer Center

Norwalk, Connecticut, United States

Site Status

Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Northwest Georgia Oncology Centers

Marietta, Georgia, United States

Site Status

Maryland Oncology Hematology, P.A.

Rockville, Maryland, United States

Site Status

Michigan State University

Lansing, Michigan, United States

Site Status

Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Site Status

Kansas City Research Institute, LLC - Phase I Unit

Kansas City, Missouri, United States

Site Status

University of Cincinnati - PARENT

Cincinnati, Ohio, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Oncology/Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Site Status

OSU - James Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status

Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization

Greenville, South Carolina, United States

Site Status

The West Clinic

Germantown, Tennessee, United States

Site Status

SCRI - Tennessee Oncology

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Oncology Consultants, P.A.

Houston, Texas, United States

Site Status

Henry Ford Hospital

San Antonio, Texas, United States

Site Status

University of Vermont Medical Center - Fletcher Allen Gastroenterology

Burlington, Vermont, United States

Site Status

Instituto Alexander Fleming

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Clínica Universitaria Privada Reina Fabiola

Córdoba, , Argentina

Site Status

Ballarat Health Services

Ballarat, , Australia

Site Status

Monash Medical Centre Clayton

Clayton, , Australia

Site Status

Centre Hospitalier de l'Ardenne - Pharmacie

Libramont, , Belgium

Site Status

Clinique CHC MontLégia

Liège, , Belgium

Site Status

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, , Brazil

Site Status

MHAT for women's health - Nadezhda, OOD

Sofia, , Bulgaria

Site Status

Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent

Benešov, , Czechia

Site Status

Masarykuv onkologicky ustav - 300176866 Parent

Brno, , Czechia

Site Status

CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale

Besançon, , France

Site Status

Centre Oscar Lambret - Service d'Oncologie medicale

Lille, , France

Site Status

ICO - Site Paul Papin - service d'oncologie medicale

Nantes, , France

Site Status

ICO - Site René Gauducheau - Service d'Oncologie medicale

Nantes, , France

Site Status

Centre Antoine Lacassagne - Service d'Hématologie Oncologie

Nice, , France

Site Status

Institut Curie - site de Paris - Service d'Oncologie Médicale

Paris, , France

Site Status

CHU Bordeaux - Service d'Oncologie Médicale

Pessac, , France

Site Status

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires

Pessac, , France

Site Status

CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

Poitiers, , France

Site Status

Centre Paul Strauss - Service de Médecine Oncologique

Strasbourg, , France

Site Status

Hopital Larrey - Service de Pneumologie et Oncologie Thoracique

Toulouse, , France

Site Status

Universitaetsklinikum Essen - Westdeutsches Tumorzentrum

Essen, , Germany

Site Status

Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly

Győr, , Hungary

Site Status

Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly

Zalaegerszeg, , Hungary

Site Status

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia

Napoli, , Italy

Site Status

IOV - Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Roma, , Italy

Site Status

Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A

Roma, , Italy

Site Status

Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

Rozzano, , Italy

Site Status

National Cancer Center Hospital (NCCH)

Chūōku, , Japan

Site Status

National Cancer Center Hospital - Dept of Gastrointestinal Oncology

Chūōku, , Japan

Site Status

Osaka Habikino Medical Center - Dept of Pulmonary Oncology

Habikino-shi, , Japan

Site Status

Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

Kōtoku, , Japan

Site Status

Kurume University Hospital - Dept of Lung Cancer Center

Kurume-shi, , Japan

Site Status

Osaka City General Hospital - Dept of Clinical Oncology

Osaka, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Osaka University Hospital - Dept of Gastrointestinal Surgery

Suita-shi, , Japan

Site Status

Health Pharma Professional Research S.A. de C.V.

México, , Mexico

Site Status

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology

Warsaw, , Poland

Site Status

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III

Cluj-Napoca, , Romania

Site Status

S.C Radiotherapy Center Cluj S.R.L - Parent

Comuna Floresti, , Romania

Site Status

Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala

Iași, , Romania

Site Status

Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala

Oradea, , Romania

Site Status

S.C Oncomed S.R.L - Specialitatea Oncologie Medicala

Timișoara, , Romania

Site Status

RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee

Kursk, , Russia

Site Status

SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

Novosibirsk, , Russia

Site Status

BHI of Omsk region "Clinical Oncology Dispensary" - Building #2

Omsk, , Russia

Site Status

FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent

Saint Petersburg, , Russia

Site Status

LLC "Medical Technologies" - Parent

Saint Petersburg, , Russia

Site Status

Pavlov First Saint Petersburg State Medical University - PARENT

Saint Petersburg, , Russia

Site Status

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Daejeon, , South Korea

Site Status

National Cancer Center

Goyang, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Hospital de la Santa Creu i Sant Pau - Dept of Oncology

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

Madrid, , Spain

Site Status

Hospital de Mataro - Servicio de Oncologia Medica

Mataró, , Spain

Site Status

Songklanagarind Hospital - Department of Medicine

Songkhla, , Thailand

Site Status

Adana City Hospital - Parent Account

Adana, , Turkey (Türkiye)

Site Status

Ankara University Medical Faculty - Medical Oncology

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty - Oncology

Ankara, , Turkey (Türkiye)

Site Status

Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology

Istanbul, , Turkey (Türkiye)

Site Status

Medipol University Medical Faculty - Parent

Istanbul, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty - PARENT

Izmir, , Turkey (Türkiye)

Site Status

Mersin University Medical Faculty - Medical Oncology

Mersin, , Turkey (Türkiye)

Site Status

CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room

Kherson, , Ukraine

Site Status

BP Medical

Vinnytsia, , Ukraine

Site Status

Podilskyi Regional Oncological Center - Dept of Chemotherapy

Vinnytsia, , Ukraine

Site Status

Sarah Cannon Research Institute UK

London, , United Kingdom

Site Status

Mount Vernon Cancer Centre

Northwood, , United Kingdom

Site Status

Derriford Hospital - Dept of Oncology Clinical Trials

Plymouth, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Bulgaria Czechia France Germany Hungary Italy Japan Mexico Poland Romania Russia South Korea Spain Thailand Turkey (Türkiye) Ukraine United Kingdom

Related Links

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https://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

Other Identifiers

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2018-003711-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-514274-46-00

Identifier Type: CTIS

Identifier Source: secondary_id

MS100070_0176

Identifier Type: -

Identifier Source: org_study_id

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