Prostate Cancer Clinical Trial

A Study of Atezolizumab in Advanced Solid Tumors

Summary

The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
Life expectancy > 3 months

Exclusion Criteria:

Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
History of asymptomatic or symptomatic central nervous system (CNS) metastasis
Leptomeningeal disease
Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
Pregnant and lactating women
Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
Severe infection within 4 weeks prior to Day 1 of Cycle 1
Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
Active tuberculosis
Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

474

Study ID:

NCT02458638

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 47 Locations for this study

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Columbia University Medical Center
New York New York, 10027, United States
Memorial Sloan Kettering
New York New York, 10065, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Sarah Cannon Cancer Center and Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz , 8036, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
Wien , 1090, Austria
INCA 1- Instituto Nacional de Câncer X
Rio de Janeiro RJ, 20231, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N , 8200, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
Odense C , 5000, Denmark
Helsinki University Central Hospital; Dept of Oncology
Helsinki , 00029, Finland
Institut Bergonie
Bordeaux , 33076, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Hopital Saint Louis, Service D Oncologie Medicale
Paris , 75475, France
Institut Gustave Roussy
Villejuif , 94805, France
Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
Hamburg , 20246, Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg , 69120, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier , 54290, Germany
St Vincent'S Uni Hospital; Medical Oncology
Dublin , 4, Ireland
St James' Hospital; Cancer Clinical Trials Office
Dublin , , Ireland
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena Toscana, 53100, Italy
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
Haukeland Universitetssjukehus; Klinisk forskningspost
Bergen , 5021, Norway
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo , 0310, Norway
Centrum Onkologii w Bydgoszczy
Bydgoszcz , 85-79, Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
Warszawa , 02-78, Poland
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow , 11547, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint-Petersburg , 19775, Russian Federation
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Freiburger Spital; Onkologie
Fribourg , 1708, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen , 9007, Switzerland
Trakya University Medical Faculty
Edirne , 22030, Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul , 34300, Turkey
Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
Istanbul , 34384, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara , 06230, Turkey
Clatterbridge Cancer Centre
Bebington , CH63 , United Kingdom
Southampton General Hospital; Medical Oncology
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

474

Study ID:

NCT02458638

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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