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Active (not recruiting) Phase 3 NCT03815643

Avelumab Program Rollover Study

Phase 3 – large-scale trial before approval
Conditions: Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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ingredients * Participant has been enrolled in the comparator arm of avelumab parent study * Participant has been withdrawn from avelumab parent study for any reason * Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the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.
Locations 22
Argentina (1)
Instituto Alexander Fleming
Ciudad Autonoma Buenos Aires
Australia (1)
Ballarat Health Services
Ballarat
Belgium (1)
Centre Hospitalier de l'Ardenne - Pharmacie
Libramont
Brazil (1)
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos
Bulgaria (1)
MHAT for women's health - Nadezhda, OOD
Sofia
Czech Republic (1)
Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent
Benešov
France (1)
CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale
Besançon
Germany (1)
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
Essen
Hungary (1)
Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly
Győr
Italy (1)
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia
Naples
Japan (1)
National Cancer Center Hospital (NCCH)
Chūōku
Mexico (1)
Health Pharma Professional Research S.A. de C.V.
México
Poland (1)
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology
Warsaw
Romania (1)
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III
Cluj-Napoca
Russia (1)
RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee
Kursk
South Korea (1)
Chungbuk National University Hospital
Cheongju-si
Spain (1)
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
Barcelona
Thailand (1)
Songklanagarind Hospital - Department of Medicine
Songkhla
Turkey (1)
Adana City Hospital - Parent Account
Adana
Ukraine (1)
CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room
Kherson
United Kingdom (1)
Sarah Cannon Research Institute UK
London
United States (1)
HonorHealth Research Institute
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.03.2019
Completion date
21.08.2026
Registry ID
NCT03815643
Source
anzctr
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