Avelumab Program Rollover Study
- Registration Number
- NCT03815643
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 205
-
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.
- 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- Participant has been withdrawn from avelumab parent study for any reason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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avelumab Avelumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (103)
Norwalk Hospital - The Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Institut Curie - site de Paris - Service d'Oncologie Médicale
🇫🇷Paris Cedex 05, France
CHU Bordeaux - Service d'Oncologie Médicale
🇫🇷Pessac, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
🇫🇷Pessac, France
Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
ðŸ‡ðŸ‡ºGyor, Hungary
Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly
ðŸ‡ðŸ‡ºZalaegerszeg, Hungary
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
🇮🇹Rozzano, Italy
The West Clinic
🇺🇸Germantown, Tennessee, United States
ICO - Site Paul Papin - service d'oncologie medicale
🇫🇷Nantes Cedex 01, France
National Cancer Center Hospital - Dept of Gastrointestinal Oncology
🇯🇵Chuo-ku, Japan
ICO - Site René Gauducheau - Service d'Oncologie medicale
🇫🇷Nantes Cedex 01, France
Centre Paul Strauss - Service de Médecine Oncologique
🇫🇷Strasbourg Cedex, France
Hopital Larrey - Service de Pneumologie et Oncologie Thoracique
🇫🇷Toulouse Cedex 9, France
Medipol University Medical Faculty - Parent
🇹🇷Istanbul, Turkey
Ege University Medical Faculty - PARENT
🇹🇷Izmir, Turkey
SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
🇷🇺Novosibirsk, Russian Federation
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
🇪🇸Madrid, Spain
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Centre Hospitalier de l'Ardenne - Pharmacie
🇧🇪Libramont, Belgium
Maryland Oncology Hematology, P.A.
🇺🇸Rockville, Maryland, United States
Ballarat Health Services
🇦🇺Ballarat, Australia
Oncology Consultants, P.A.
🇺🇸Houston, Texas, United States
Clinique CHC MontLégia
🇧🇪Liège, Belgium
CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
🇫🇷Besancon Cedex, France
Centre Oscar Lambret - Service d'Oncologie medicale
🇫🇷Lille cedex, France
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Masarykuv onkologicky ustav - 300176866 Parent
🇨🇿Brno, Czechia
ClÃnica Universitaria Privada Reina Fabiola
🇦🇷Cordoba, Argentina
MHAT for women's health - Nadezhda, OOD
🇧🇬Sofia, Bulgaria
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
🇫🇷Nice, France
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
🇮🇹Napoli, Italy
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Instituto Alexander Fleming
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
🇩🇪Essen, Germany
University of Vermont Medical Center - Fletcher Allen Gastroenterology
🇺🇸Burlington, Vermont, United States
Monash Medical Centre Clayton
🇦🇺Clayton, Australia
Mount Vernon Cancer Centre
🇬🇧Northwood, United Kingdom
Osaka Habikino Medical Center - Dept of Pulmonary Oncology
🇯🇵Habikino-shi, Japan
Chonnam National University Hwasun Hospital
🇰🇷Daejeon, Korea, Republic of
University of Cincinnati - PARENT
🇺🇸Cincinnati, Ohio, United States
Kansas City Research Institute, LLC - Phase I Unit
🇺🇸Kansas City, Missouri, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
SCRI - Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital
🇺🇸San Antonio, Texas, United States
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
🇮🇹Roma, Italy
Osaka University Hospital - Dept of Gastrointestinal Surgery
🇯🇵Suita-shi, Japan
National Cancer Center
🇰🇷Goyang, Korea, Republic of
S.C Radiotherapy Center Cluj S.R.L - Parent
🇷🇴Comuna Floresti, Romania
LLC "Medical Technologies" - Parent
🇷🇺Saint Petersburg, Russian Federation
Northwest Georgia Oncology Centers
🇺🇸Marietta, Georgia, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
University of California Davis Health System - Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
St Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Oncology/Hematology Care Clinical Trials, LLC
🇺🇸Cincinnati, Ohio, United States
OSU - James Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
🇨🇿Benesov, Czechia
Hospital de Câncer de Barretos - Fundação Pio XII
🇧🇷Barretos, Brazil
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
🇫🇷Poitiers cedex, France
IOV - Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
National Cancer Center Hospital (NCCH)
🇯🇵Chuo-ku, Japan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
🇮🇹Roma, Italy
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
🇯🇵Koto-ku, Japan
Kurume University Hospital - Dept of Lung Cancer Center
🇯🇵Kurume-shi, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Japan
Osaka City General Hospital - Dept of Clinical Oncology
🇯🇵Osaka-shi, Japan
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Health Pharma Professional Research S.A. de C.V.
🇲🇽Mexico, Mexico
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
🇵🇱Warszawa, Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
🇷🇴Cluj Napoca, Romania
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
🇷🇴Oradea, Romania
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
🇷🇺Kursk, Russian Federation
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
🇷🇴Iasi, Romania
S.C Oncomed S.R.L - Specialitatea Oncologie Medicala
🇷🇴Timisoara, Romania
BHI of Omsk region "Clinical Oncology Dispensary" - Building #2
🇷🇺Omsk, Russian Federation
FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent
🇷🇺Saint-Petersburg, Russian Federation
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
🇪🇸Barcelona, Spain
Pavlov First Saint Petersburg State Medical University - PARENT
🇷🇺Saint-Petersburg, Russian Federation
Hospital Universitari Vall d'Hebron - Oncology Dept.
🇪🇸Barcelona, Spain
Hospital de Mataro - Servicio de Oncologia Medica
🇪🇸Mataro, Spain
Adana City Hospital - Parent Account
🇹🇷Adana, Turkey
Songklanagarind Hospital - Department of Medicine
🇹ðŸ‡Songkla, Thailand
Hacettepe University Medical Faculty - Oncology
🇹🇷Ankara, Turkey
Ankara University Medical Faculty - Medical Oncology
🇹🇷Ankara, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
🇹🇷Istanbul, Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology
🇹🇷Istanbul, Turkey
Mersin University Medical Faculty - Medical Oncology
🇹🇷Mersin, Turkey
Podilskyi Regional Oncological Center - Dept of Chemotherapy
🇺🇦Vinnytsia, Ukraine
CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
🇺🇦Kherson, Ukraine
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Derriford Hospital - Dept of Oncology Clinical Trials
🇬🇧Plymouth, United Kingdom
Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization
🇺🇸Greenville, South Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States