Avelumab Program Rollover Study

NCT03815643 · tracked via the Priya Life Science UK tracker

Sponsor

EMD Serono Research & Development Institute, Inc.

Phase

Phase 3

Started

2019-03-22

Last updated

2026-06-29

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

Avelumab

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).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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ingredients * Participant has been enrolled in the comparator arm of avelumab parent study * Participant has been withdrawn from avelumab parent study for any reason * Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the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.

Primary outcome measure(s)

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)

Trial sites (104)

Facility	City	Region
HonorHealth Research Institute	Scottsdale	Arizona
Highlands Oncology Group	Fayetteville	Arkansas
University of California Davis Health System - Comprehensive Cancer Center	Sacramento	California
Providence Medical Foundation	Santa Rosa	California
St Joseph Heritage Healthcare	Santa Rosa	California
Norwalk Hospital - The Whittingham Cancer Center	Norwalk	Connecticut
Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast	Port Saint Lucie	Florida
Northwest Georgia Oncology Centers	Marietta	Georgia
Maryland Oncology Hematology, P.A.	Rockville	Maryland
Michigan State University	Lansing	Michigan
Virginia Piper Cancer Institute	Minneapolis	Minnesota
Kansas City Research Institute, LLC - Phase I Unit	Kansas City	Missouri
University of Cincinnati - PARENT	Cincinnati	Ohio
Oncology Hematology Care	Cincinnati	Ohio
Oncology/Hematology Care Clinical Trials, LLC	Cincinnati	Ohio
OSU - James Comprehensive Cancer Center	Columbus	Ohio
Oregon Health & Science University	Portland	Oregon
Rhode Island Hospital	Providence	Rhode Island
Medical University of South Carolina (MUSC)	Charleston	South Carolina
Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization	Greenville	South Carolina
The West Clinic	Germantown	Tennessee
SCRI - Tennessee Oncology	Nashville	Tennessee
University of Texas Southwestern Medical Center	Dallas	Texas
Oncology Consultants, P.A.	Houston	Texas
Henry Ford Hospital	San Antonio	Texas
University of Vermont Medical Center - Fletcher Allen Gastroenterology	Burlington	Vermont
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

+ 64 more sites — see the full list on the official registry below.

More EMD Serono Research & Development Institute, Inc. trials in the UK

Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) Active, not recruiting

Met Non Small Cell Cancer Registry (MOMENT) Recruiting

Anti-GD2 ADC M3554 in Advanced Solid Tumors Recruiting

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) Active, not recruiting

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) Recruiting

Other trials for the same condition

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials Recruiting

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors Active, not recruiting

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Recruiting

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma Recruiting

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03815643 on ClinicalTrials.gov ↗ ← All trials in the UK