An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Brain Neoplasms Clinical Trial

— CheckMate548  

Official title:

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667587
• Other study ID #: CA209-548
• Secondary ID: 2015-004722-34
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2016
• Est. completion date: April 9, 2024

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: April 9, 2024
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Males and Females, age = 18 years old

• Newly diagnosed brain cancer or tumor called glioblastoma or GBM

• Karnofsky performance status of = 70 (able to take care of self)

• Substantial recovery from surgery resection

• Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion Criteria:

• Biopsy-only of GBM with less than 20% of tumor removed

• Prior treatment for GBM (other than surgical resection)

• Any known tumor outside of the brain

• Recurrent or secondary GBM

• Active known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioblastoma

Intervention

Drug:
• Nivolumab

• Temozolomide

Radiation:
• Radiotherapy

Other:
• Nivolumab Placebo

Locations

Country	Name	City	State
Australia	Local Institution - 0050	Heidelberg	Victoria
Australia	Local Institution - 0049	Liverpool	New South Wales
Australia	Local Institution - 0122	Nedlands	Western Australia
Australia	Local Institution - 0051	Prahran	Victoria
Australia	Local Institution - 0052	St. Leonards	New South Wales
Austria	Local Institution - 0062	Linz
Austria	Local Institution - 0061	Vienna
Belgium	Local Institution - 0070	Brussels
Belgium	Local Institution - 0069	Bruxelles
Belgium	Local Institution - 0071	Leuven
Canada	Local Institution - 0047	Montreal	Quebec
Canada	Local Institution - 0048	Toronto	Ontario
Canada	Local Institution - 0046	Vancouver	British Columbia
Denmark	Local Institution - 0084	Copenhagen
Denmark	Local Institution - 0085	Odense
France	Local Institution - 0043	Lille Cedex
France	Local Institution - 0041	Lyon Cedex 03
France	Local Institution - 0040	Marseille
France	Local Institution - 0042	Nancy
France	Local Institution - 0038	Paris
France	Local Institution - 0039	Paris cedex 13
France	Local Institution - 0044	Rennes Cedex
France	Local Institution - 0045	Toulouse
Germany	Local Institution - 0055	Bonn
Germany	Local Institution - 0123	Erlangen
Germany	Local Institution - 0053	Frankfurt Am Main
Germany	Local Institution - 0124	Freiburg
Germany	Local Institution - 0057	Hamburg
Germany	Local Institution - 0056	Heidelberg
Germany	Local Institution - 0131	Koeln
Germany	Local Institution - 0054	Muenster
Germany	Local Institution - 0130	Munich
Germany	Local Institution - 0058	Regensburg
Germany	Local Institution - 0059	Tuebingen
Israel	Local Institution - 0094	Petach Tikva
Israel	Local Institution - 0093	Tel Aviv
Italy	Local Institution - 0088	Bologna
Italy	Local Institution - 0089	Milano
Italy	Local Institution - 0092	Padova
Italy	Local Institution - 0127	Rozzano (milano)
Italy	Local Institution - 0090	Siena
Italy	Local Institution - 0091	Torino
Japan	Local Institution - 0114	Bunkyo-ku	Tokyo
Japan	Local Institution - 0099	Chiba-shi	Chiba
Japan	Local Institution - 0111	Chuo-ku	Tokyo
Japan	Local Institution - 0121	Hidaka-shi	Saitama
Japan	Local Institution - 0104	Hirakata-shi	Osaka
Japan	Local Institution - 0100	Hiroshima-Shi	Hiroshima
Japan	Local Institution - 0102	Kagoshima-shi	Kagoshima
Japan	Local Institution - 0103	Kanazawa-shi	Ishikawa
Japan	Local Institution - 0105	Kobe-shi	Hyogo
Japan	Local Institution - 0106	Kumamoto-shi	Kumamoto
Japan	Local Institution - 0108	Kyoto
Japan	Local Institution - 0109	Kyoto
Japan	Local Institution - 0107	Mitaka-shi	Tokyo
Japan	Local Institution - 0110	Nagoya-shi	Aichi
Japan	Local Institution - 0120	Okayama-shi	Okayama
Japan	Local Institution - 0118	Sagamihara-shi	Kanagawa
Japan	Local Institution - 0101	Sapporo-shi	Hokkaido
Japan	Local Institution - 0115	Shinjuku-ku	Tokyo
Japan	Local Institution - 0112	Suita	Osaka
Japan	Local Institution - 0116	Tsukuba-shi	Ibaraki
Japan	Local Institution - 0117	Yamagata-shi	Yamagata
Netherlands	Local Institution - 0075	Amsterdam
Netherlands	Local Institution - 0074	Groningen
Netherlands	Local Institution - 0073	Rotterdam	Zuid-Holland
Netherlands	Local Institution - 0072	Utrecht
Norway	Local Institution - 0083	Oslo
Poland	Local Institution - 0086	Gdansk
Poland	Local Institution - 0132	Warszawa
Russian Federation	Local Institution - 0095	Moscow
Russian Federation	Local Institution - 0097	Moscow
Spain	Local Institution - 0126	Badalona-barcelona
Spain	Local Institution - 0078	Barcelona
Spain	Local Institution - 0125	Barcelona
Spain	Local Institution - 0076	Madrid
Spain	Local Institution - 0077	Madrid
Spain	Local Institution - 0080	Santiago Compostela
Spain	Local Institution - 0079	Valencia
Sweden	Local Institution - 0081	Lund
Sweden	Local Institution - 0082	Solna
Switzerland	Local Institution - 0065	Geneve
Switzerland	Local Institution - 0064	Lausanne
Switzerland	Local Institution - 0063	Zuerich
United Kingdom	Local Institution - 0068	Glasgow
United Kingdom	Local Institution - 0067	London
United Kingdom	Local Institution - 0066	Manchester	Greater Manchester
United Kingdom	Local Institution - 0119	Sutton	Surrey
United States	Local Institution - 0098	Allentown	Pennsylvania
United States	Local Institution - 0020	Baltimore	Maryland
United States	Local Institution - 0023	Birmingham	Alabama
United States	Local Institution - 0011	Boston	Massachusetts
United States	Local Institution - 0028	Boston	Massachusetts
United States	Local Institution - 0021	Charleston	South Carolina
United States	Local Institution - 0032	Charlotte	North Carolina
United States	Erlanger Oncology & Hematology - Univ. of TN	Chattanooga	Tennessee
United States	Local Institution - 0022	Chicago	Illinois
United States	Local Institution - 0001	Cleveland	Ohio
United States	Local Institution - 0027	Columbus	Ohio
United States	Local Institution - 0025	Dallas	Texas
United States	Local Institution - 0035	Detroit	Michigan
United States	Preston Robert Tisch Brain Tumor Center at Duke University	Durham	North Carolina
United States	Local Institution - 0017	Edison	New Jersey
United States	Local Institution - 0012	Hackensack	New Jersey
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Local Institution - 0010	Los Angeles	California
United States	Local Institution - 0018	Louisville	Kentucky
United States	Local Institution - 0087	Miami	Florida
United States	Local Institution - 0008	Nashville	Tennessee
United States	Local Institution - 0004	New Haven	Connecticut
United States	Local Institution - 0015	New York	New York
United States	Local Institution - 0024	New York	New York
United States	Local Institution - 0016	Philadelphia	Pennsylvania
United States	Local Institution - 0003	Phoenix	Arizona
United States	Local Institution - 0128	Sacramento	California
United States	Local Institution - 0002	Saint Louis	Missouri
United States	Local Institution - 0009	Salt Lake City	Utah
United States	Local Institution - 0029	San Diego	California
United States	Local Institution - 0006	San Francisco	California
United States	Local Institution - 0005	Seattle	Washington
United States	Local Institution - 0030	Tampa	Florida
United States	Local Institution - 0031	Washington	District of Columbia
United States	Local Institution - 0060	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Determined by BICR	The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Primary	Overall Survival (OS)	The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.	From randomization to date of death (up to approximately 4.5 years)
Secondary	Overall Survival (OS) Rates at 12 Months	Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months	From randomization to 12 months after first dose
Secondary	Overall Survival (OS) Rates at 24 Months	Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months	From randomization to 24 months after first dose
Secondary	Progression Free Survival (PFS) Based on Investigator Assessment	The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting