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NCT03815643 Clinical Trial

Avelumab Program Rollover Study

Solid Tumors Clinical Trial

Official title:
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03815643
Other study ID # MS100070_0176
Secondary ID 2018-003711-21
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 22, 2019
Est. completion date November 1, 2024

Study information
Verified date May 2024
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 205
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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ingredients - Participant has been enrolled in the comparator arm of avelumab parent study - Participant has been withdrawn from avelumab parent study for any reason - Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Argentina Instituto Alexander Fleming Ciudad Autonoma Buenos Aires
Argentina Clínica Universitaria Privada Reina Fabiola Cordoba
Australia Ballarat Health Services Ballarat
Australia Monash Medical Centre Clayton Clayton
Belgium Centre Hospitalier de l'Ardenne - Pharmacie Libramont
Belgium Clinique CHC MontLégia Liège
Brazil Hospital de Câncer de Barretos - Fundação Pio XII Barretos
Bulgaria MHAT for women's health - Nadezhda, OOD Sofia
Czechia Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent Benesov
Czechia Masarykuv onkologicky ustav - 300176866 Parent Brno
France CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale Besancon Cedex
France Centre Oscar Lambret - Service d'Oncologie medicale Lille cedex
France ICO - Site Paul Papin - service d'oncologie medicale Nantes Cedex 01
France ICO - Site René Gauducheau - Service d'Oncologie medicale Nantes Cedex 01
France Centre Antoine Lacassagne - Service d'Hématologie Oncologie Nice
France 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 CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale Poitiers cedex
France Centre Paul Strauss - Service de Médecine Oncologique Strasbourg Cedex
France Hopital Larrey - Service de Pneumologie et Oncologie Thoracique Toulouse Cedex 9
Germany Universitaetsklinikum Essen - Westdeutsches Tumorzentrum Essen
Hungary Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly Gyor
Hungary Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly Zalaegerszeg
Italy Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia Napoli
Italy IOV - Istituto Oncologico Veneto IRCCS Padova
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica Roma
Italy Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A Roma
Italy Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia Rozzano
Japan National Cancer Center Hospital (NCCH) Chuo-ku
Japan National Cancer Center Hospital - Dept of Gastrointestinal Oncology Chuo-ku
Japan Osaka Habikino Medical Center - Dept of Pulmonary Oncology Habikino-shi
Japan Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine Koto-ku
Japan Kurume University Hospital - Dept of Lung Cancer Center Kurume-shi
Japan Osaka City General Hospital - Dept of Clinical Oncology Osaka-shi
Japan Tohoku University Hospital Sendai-shi
Japan Osaka University Hospital - Dept of Gastrointestinal Surgery Suita-shi
Korea, Republic of Chungbuk National University Hospital Cheongju-si
Korea, Republic of Chonnam National University Hwasun Hospital Daejeon
Korea, Republic of National Cancer Center Goyang
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 Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Mexico Health Pharma Professional Research S.A. de C.V. Mexico
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy - Dept of Lungs and Chest Oncology Warszawa
Romania Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III Cluj Napoca
Romania S.C Radiotherapy Center Cluj S.R.L - Parent Comuna Floresti
Romania Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala Iasi
Romania Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala Oradea
Romania S.C Oncomed S.R.L - Specialitatea Oncologie Medicala Timisoara
Russian Federation RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee Kursk
Russian Federation SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary" Novosibirsk
Russian Federation BHI of Omsk region "Clinical Oncology Dispensary" - Building #2 Omsk
Russian Federation LLC "Medical Technologies" - Parent Saint Petersburg
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 Pavlov First Saint Petersburg State Medical University - PARENT Saint-Petersburg
Spain Hospital de la Santa Creu i Sant Pau - Dept of Oncology Barcelona
Spain Hospital Universitari Vall d'Hebron - Oncology Dept. Barcelona
Spain Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica Madrid
Spain Hospital de Mataro - Servicio de Oncologia Medica Mataro
Thailand Songklanagarind Hospital - Department of Medicine Songkla
Turkey Adana City Hospital - Parent Account Adana
Turkey Ankara University Medical Faculty - Medical Oncology Ankara
Turkey Hacettepe University Medical Faculty - Oncology Ankara
Turkey Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology Istanbul
Turkey Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology Istanbul
Turkey Medipol University Medical Faculty - Parent Istanbul
Turkey Ege University Medical Faculty - PARENT Izmir
Turkey Mersin University Medical Faculty - Medical Oncology Mersin
Ukraine CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room Kherson
Ukraine Podilskyi Regional Oncological Center - Dept of Chemotherapy Vinnytsia
United Kingdom Sarah Cannon Research Institute UK London
United Kingdom Mount Vernon Cancer Centre Northwood
United Kingdom Derriford Hospital - Dept of Oncology Clinical Trials Plymouth
United States University of Vermont Medical Center - Fletcher Allen Gastroenterology Burlington Vermont
United States Medical University of South Carolina (MUSC) Charleston South Carolina
United States Oncology Hematology Care Cincinnati Ohio
United States Oncology/Hematology Care Clinical Trials, LLC Cincinnati Ohio
United States University of Cincinnati - PARENT Cincinnati Ohio
United States OSU - James Comprehensive Cancer Center Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Highlands Oncology Group Fayetteville Arkansas
United States The West Clinic Germantown Tennessee
United States Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization Greenville South Carolina
United States Oncology Consultants, P.A. Houston Texas
United States Kansas City Research Institute, LLC - Phase I Unit Kansas City Missouri
United States Michigan State University Lansing Michigan
United States Northwest Georgia Oncology Centers Marietta Georgia
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States SCRI - Tennessee Oncology Nashville Tennessee
United States Norwalk Hospital - The Whittingham Cancer Center Norwalk Connecticut
United States Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast Port Saint Lucie Florida
United States Oregon Health & Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Maryland Oncology Hematology, P.A. Rockville Maryland
United States University of California Davis Health System - Comprehensive Cancer Center Sacramento California
United States Henry Ford Hospital San Antonio Texas
United States Providence Medical Foundation Santa Rosa California
United States St Joseph Heritage Healthcare Santa Rosa California
United States HonorHealth Research Institute Scottsdale Arizona

Sponsors (2)
Lead Sponsor Collaborator
EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Overall Survival (OS) From baseline up to 5 years
Secondary Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) From baseline up to 5 years
Secondary Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) From baseline up to 5 years
See also
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Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
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Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Withdrawn NCT01940601 - Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors Phase 2

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