Avelumab Program Rollover Study

June 26, 2026 updated by: EMD Serono Research & Development Institute, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
        • Instituto Alexander Fleming
      • Córdoba, Argentina
        • Clinica 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
      • Padova, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From baseline up to 5 years
From baseline up to 5 years
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: From baseline up to 5 years
From baseline up to 5 years
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Time Frame: From baseline up to 5 years
From baseline up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EMD Serono Research & Development Institute, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS100070_0176
  • 2018-003711-21 (EudraCT Number)
  • 2024-514274-46-00 (Ctis)
  • jRCT2080224625 (Other Identifier: JRCT (Japan))
  • JapicCTI-194697 (Other Identifier: JAPIC (Japan))

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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