Solid TumorsPhase 3NCT03815643
Avelumab Program Rollover Study
A Phase 3 study testing Avelumab in people with Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 104 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 104 sitesin 22 countries
- Study dates
- 22 Mar 2019to 24 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- Participant has been withdrawn from avelumab parent study for any reason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.
Trial locations and contacts
104 sites in 22 countries.
104 sites in 22 countries
United States26 sites
University of Vermont Medical Center - Fletcher Allen Gastroenterology
Burlington, Vermont, 05401
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
University of Cincinnati - PARENT
Cincinnati, Ohio, 45229
Oncology Hematology Care
Cincinnati, Ohio, 45242
Oncology/Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
OSU - James Comprehensive Cancer Center
Columbus, Ohio, 43210-1228
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8857
Highlands Oncology Group
Fayetteville, Arkansas, 72703
The West Clinic
Germantown, Tennessee, 38138
Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization
Greenville, South Carolina, 29605
Oncology Consultants, P.A.
Houston, Texas, 77030
Kansas City Research Institute, LLC - Phase I Unit
Kansas City, Missouri, 64131
Michigan State University
Lansing, Michigan, 48910
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203
Norwalk Hospital - The Whittingham Cancer Center
Norwalk, Connecticut, 06850
Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
Oregon Health & Science University
Portland, Oregon, 97201
Rhode Island Hospital
Providence, Rhode Island, 02903
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850
University of California Davis Health System - Comprehensive Cancer Center
Sacramento, California, 95817
Henry Ford Hospital
San Antonio, Texas, 78229
Providence Medical Foundation
Santa Rosa, California, 95403
St Joseph Heritage Healthcare
Santa Rosa, California, 95403
HonorHealth Research Institute
Scottsdale, Arizona, 85258
France11 sites
CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
Besançon
Centre Oscar Lambret - Service d'Oncologie medicale
Lille
ICO - Site Paul Papin - service d'oncologie medicale
Nantes
ICO - Site René Gauducheau - Service d'Oncologie medicale
Nantes
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice
Institut Curie - site de Paris - Service d'Oncologie Médicale
Paris
CHU Bordeaux - Service d'Oncologie Médicale
Pessac
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
Pessac
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers
Centre Paul Strauss - Service de Médecine Oncologique
Strasbourg
Hopital Larrey - Service de Pneumologie et Oncologie Thoracique
Toulouse
South Korea9 sites
Chungbuk National University Hospital
Cheongju-si
Chonnam National University Hwasun Hospital
Daejeon
National Cancer Center
Goyang
Gachon University Gil Medical Center
Incheon
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Japan8 sites
National Cancer Center Hospital (NCCH)
Chūōku
National Cancer Center Hospital - Dept of Gastrointestinal Oncology
Chūōku
Osaka Habikino Medical Center - Dept of Pulmonary Oncology
Habikino-shi
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
Kōtoku
Kurume University Hospital - Dept of Lung Cancer Center
Kurume-shi
Osaka City General Hospital - Dept of Clinical Oncology
Osaka
Tohoku University Hospital
Sendai
Osaka University Hospital - Dept of Gastrointestinal Surgery
Suita-shi
Turkey (Türkiye)8 sites
Adana City Hospital - Parent Account
Adana
Ankara University Medical Faculty - Medical Oncology
Ankara
Hacettepe University Medical Faculty - Oncology
Ankara
Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Istanbul
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology
Istanbul
Medipol University Medical Faculty - Parent
Istanbul
Ege University Medical Faculty - PARENT
Izmir
Mersin University Medical Faculty - Medical Oncology
Mersin
Russia6 sites
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
Kursk
SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
Novosibirsk
BHI of Omsk region "Clinical Oncology Dispensary" - Building #2
Omsk
FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent
Saint Petersburg
LLC "Medical Technologies" - Parent
Saint Petersburg
Pavlov First Saint Petersburg State Medical University - PARENT
Saint Petersburg
Italy5 sites
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
Naples
IOV - Istituto Oncologico Veneto IRCCS
Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
Roma
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Rozzano
Romania5 sites
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
Cluj-Napoca
S.C Radiotherapy Center Cluj S.R.L - Parent
Comuna Floresti
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
Iași
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
Oradea
S.C Oncomed S.R.L - Specialitatea Oncologie Medicala
Timișoara
Spain4 sites
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid
Hospital de Mataro - Servicio de Oncologia Medica
Mataró
Ukraine3 sites
CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
Kherson
BP Medical
Vinnytsia, 21029
Podilskyi Regional Oncological Center - Dept of Chemotherapy
Vinnytsia
United Kingdom3 sites
Sarah Cannon Research Institute UK
London
Mount Vernon Cancer Centre
Northwood
Derriford Hospital - Dept of Oncology Clinical Trials
Plymouth
Argentina2 sites
Instituto Alexander Fleming
Ciudad Autonoma Buenos Aires
Clínica Universitaria Privada Reina Fabiola
Córdoba
Australia2 sites
Ballarat Health Services
Ballarat
Monash Medical Centre Clayton
Clayton
Belgium2 sites
Centre Hospitalier de l'Ardenne - Pharmacie
Libramont
Clinique CHC MontLégia
Liège
Czechia2 sites
Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
Benešov
Masarykuv onkologicky ustav - 300176866 Parent
Brno
Hungary2 sites
Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
Győr
Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly
Zalaegerszeg
Poland1 site
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
Warsaw
About this study
Official title: 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.
- Conditions
- Solid Tumors
- Being tested
- Avelumab
- Keywords
- Avelumab, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Urothelial carcinoma (UC), Ovarian cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called MSB0010718C
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).
| Study group | Role | What they receive |
|---|---|---|
| Avelumab | Experimental | Not described Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: From baseline up to 5 years
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: From baseline up to 5 years
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Measured: From baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start22 Mar 2019
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815643
- Sponsor's protocol ID
- MS100070_0176
- Other IDs
- 2018-003711-21, 2024-514274-46-00, jRCT2080224625, JapicCTI-194697, 2018
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2019
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD supporting publicly available results will be evaluated for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
- ClinicalTrials.gov ID
- NCT03815643
- Acronym / sponsor ID
- MS100070_0176
- Conditions
- Solid Tumors
- Keywords
- Avelumab, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Urothelial carcinoma (UC), Ovarian cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 205 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelumab | Experimental | Drug: Avelumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research \& Development Institute, Inc. / Merck KGaA, Darmstadt, Germany
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAlso: MSB0010718CParticipants 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). | Drug | Avelumab |
Primary outcome
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)
3 secondary outcomes
Overall Survival (OS)
Time frame: 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
Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
Time frame: From baseline up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD supporting publicly available results will be evaluated for sharing.
Related trials for Solid Tumors
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
104 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avelumab in people with Solid Tumors, run by EMD Serono Research & Development Institute, Inc. at 104 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, France, South Korea, Japan, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.