A Study of Atezolizumab in Advanced Solid Tumors

NCT02458638 | Completed Phase 2 Results

• 2 other identifiers: MO295182015-000269-30
• Study Type: interventional
• Target: 474
• Locations: 18 countries
• Sites: 48

Brief 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.

Conditions

Tumors

Outcome Measures

Primary Outcomes (1)

• Non-progression Rate (NPR) at 18 Weeks

  NPR was 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), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated.

  At Week 18

Secondary Outcomes (16)

• NPR at 24 Weeks

  At Week 24

• Overall Response Rate (ORR)

  Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

• Percentage of Participants by Best Overall Response (BOR)

  Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

• Clinical Benefit Rate (CBR)

  Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

• Duration of Objective Response (DOR)

  Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

Study Arms (1)

Atezolizumab

EXPERIMENTAL

The dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody

Interventions

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody DRUG

Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.

Also known as: Tecentriq

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (48)

Columbia University Medical Center

New York, New York, 10027, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Sarah Cannon Cancer Center and Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

Graz, 8036, Austria

Location

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei

Vienna, 1090, Austria

Location

INCA 1- Instituto Nacional de Câncer X

Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, M5G 2M9, Canada

Location

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N, 8200, Denmark

Location

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

Location

Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

Odense C, 5000, Denmark

Location

Helsinki University Central Hospital; Dept of Oncology

Helsinki, 00029, Finland

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Location

Hopital Saint Louis, Service D Oncologie Medicale

Paris, 75475, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik

Hamburg, 20246, Germany

Location

Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

Heidelberg, 69120, Germany

Location

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

Trier, 54290, Germany

Location

St Vincent'S Uni Hospital; Medical Oncology

Dublin, 4, Ireland

Location

St James' Hospital; Cancer Clinical Trials Office

Dublin, Ireland

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Campania, 80131, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

Siena, Tuscany, 53100, Italy

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Haukeland Universitetssjukehus; Klinisk forskningspost

Bergen, 5021, Norway

Location

Oslo Universitetssykehus HF; Radiumhospitalet

Oslo, 0310, Norway

Location

Centrum Onkologii w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

Location

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.

Warsaw, 02-781, Poland

Location

Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

Moscow, 115478, Russia

Location

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, 197758, Russia

Location

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Freiburger Spital; Onkologie

Fribourg, 1708, Switzerland

Location

Kantonsspital St. Gallen; Onkologie/Hämatologie

Sankt Gallen, 9007, Switzerland

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Location

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

Istanbul, 34384, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Location

Clatterbridge Cancer Centre

Bebington, CH63 4JY, United Kingdom

Location

Southampton General Hospital; Medical Oncology

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Tabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, Jaeger D, Maio M, Mileshkin L, Melero I. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419. doi: 10.1016/j.esmoop.2022.100419. Epub 2022 Mar 16.

  PMID: 35305400 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

atezolizumab; Antibodies

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: July 16, 2015
• Primary Completion: April 4, 2018
• Study Completion: July 28, 2020
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3); TU (4); DK (3); GB (2); DE (3); US (5); IT (3); CA (2); NO (2); PL (3); ES (2); NL (3); FI (1); CH (2); RU (2); AU (2); FR (4); IE (2)