Clinical trial NCT03815643: Avelumab Program Rollover Study
Official title: An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Solid Tumors
Keywords: Avelumab
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma (RCC)
Urothelial carcinoma (UC)
Ovarian cancer
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-01-24
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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* Participant has been withdrawn from avelumab parent study for any reason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 outcomes:
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
timeFrame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From baseline up to 5 years
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: From baseline up to 5 years
measure: Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
timeFrame: From baseline up to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Sacramento
country: United States
facility: University of California Davis Health System - Comprehensive Cancer Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital - The Whittingham Cancer Center
state: Connecticut
city: Port Saint Lucie
country: United States
facility: Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Research Institute, LLC - Phase I Unit
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati - PARENT
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cincinnati
country: United States
facility: Oncology/Hematology Care Clinical Trials, LLC
state: Ohio
city: Columbus
country: United States
facility: OSU - James Comprehensive Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: SCRI - Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: San Antonio
country: United States
facility: Henry Ford Hospital
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center - Fletcher Allen Gastroenterology
state: Vermont
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Cordoba
country: Argentina
facility: Clínica Universitaria Privada Reina Fabiola
city: Ballarat
country: Australia
facility: Ballarat Health Services
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne - Pharmacie
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos - Fundação Pio XII
city: Sofia
country: Bulgaria
facility: MHAT for women's health - Nadezhda, OOD
city: Benesov
country: Czechia
facility: Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav - 300176866 Parent
city: Besancon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
city: Lille cedex
country: France
facility: Centre Oscar Lambret - Service d'Oncologie medicale
city: Nantes Cedex 01
country: France
facility: ICO - Site Paul Papin - service d'oncologie medicale
city: Nantes Cedex 01
country: France
facility: ICO - Site René Gauducheau - Service d'Oncologie medicale
city: Nice
country: France
facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie
city: Paris Cedex 05
country: France
facility: Institut Curie - site de Paris - Service d'Oncologie Médicale
city: Pessac
country: France
facility: CHU Bordeaux - Service d'Oncologie Médicale
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
city: Poitiers cedex
country: France
facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
city: Strasbourg Cedex
country: France
facility: Centre Paul Strauss - Service de Médecine Oncologique
city: Toulouse Cedex 9
country: France
facility: Hopital Larrey - Service de Pneumologie et Oncologie Thoracique
city: Essen
country: Germany
facility: Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
city: Zalaegerszeg
country: Hungary
facility: Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital (NCCH)
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital - Dept of Gastrointestinal Oncology
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center - Dept of Pulmonary Oncology
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
city: Kurume-shi
country: Japan
facility: Kurume University Hospital - Dept of Lung Cancer Center
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital - Dept of Clinical Oncology
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Suita-shi
country: Japan
facility: Osaka University Hospital - Dept of Gastrointestinal Surgery
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Mexico
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V.
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
city: Comuna Floresti
country: Romania
facility: S.C Radiotherapy Center Cluj S.R.L - Parent
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala
city: Timisoara
country: Romania
facility: S.C Oncomed S.R.L - Specialitatea Oncologie Medicala
city: Kursk
country: Russian Federation
facility: RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
city: Novosibirsk
country: Russian Federation
facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary" - Building #2
city: Saint Petersburg
country: Russian Federation
facility: LLC "Medical Technologies" - Parent
city: Saint-Petersburg
country: Russian Federation
facility: FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University - PARENT
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau - Dept of Oncology
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Oncology Dept.
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
city: Mataro
country: Spain
facility: Hospital de Mataro - Servicio de Oncologia Medica
city: Songkla
country: Thailand
facility: Songklanagarind Hospital - Department of Medicine
city: Adana
country: Turkey
facility: Adana City Hospital - Parent Account
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty - Medical Oncology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty - Oncology
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty - Parent
city: Izmir
country: Turkey
facility: Ege University Medical Faculty - PARENT
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty - Medical Oncology
city: Kherson
country: Ukraine
facility: CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
city: Vinnytsia
country: Ukraine
facility: Podilskyi Regional Oncological Center - Dept of Chemotherapy
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Plymouth
country: United Kingdom
facility: Derriford Hospital - Dept of Oncology Clinical Trials
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: