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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) (CheckMate548)

Primary Purpose

Brain Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Temozolomide

Radiotherapy

Nivolumab Placebo

About this trial

This is an interventional treatment trial for Brain Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nivolumab + Temozolomide + Radiotherapy

Nivolumab placebo + Temozolomide + Radiotherapy

Arm Description

Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks

Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Overall Survival (OS) Rates at 12 Months

Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months

Overall Survival (OS) Rates at 24 Months

Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months

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.

Full Information

NCT ID

NCT02667587

First Posted

January 26, 2016

Last Updated

September 21, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02667587

Brief Title

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)

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 9, 2016 (Actual)

Primary Completion Date

December 22, 2020 (Actual)

Study Completion Date

February 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

716 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab + Temozolomide + Radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Nivolumab placebo + Temozolomide + Radiotherapy

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, Nivo, N, BMS-936558

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar, TMZ, Temodal, Temcad

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Intervention Type

Other

Intervention Name(s)

Nivolumab Placebo

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) Determined by BICR

Description

Time Frame

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Title

Overall Survival (OS)

Description

Time Frame

From randomization to date of death (up to approximately 4.5 years)

Secondary Outcome Measure Information:

Title

Overall Survival (OS) Rates at 12 Months

Description

Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months

Time Frame

From randomization to 12 months after first dose

Title

Overall Survival (OS) Rates at 24 Months

Description

Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months

Time Frame

From randomization to 24 months after first dose

Title

Progression Free Survival (PFS) Based on Investigator Assessment

Description

Time Frame

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0023

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-3410

Country

United States

Facility Name

Local Institution - 0003

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Local Institution - 0010

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1769

Country

United States

Facility Name

Local Institution - 0128

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Local Institution - 0029

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Local Institution - 0006

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-0372

Country

United States

Facility Name

Local Institution - 0004

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 0031

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Local Institution - 0087

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Local Institution - 0030

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0022

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Local Institution - 0060

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Local Institution - 0018

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Local Institution - 0020

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Local Institution - 0011

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0028

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0035

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Local Institution - 0002

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0017

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08820

Country

United States

Facility Name

Local Institution - 0012

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Local Institution - 0015

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Local Institution - 0024

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0032

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Preston Robert Tisch Brain Tumor Center at Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Local Institution - 0001

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Local Institution - 0027

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution - 0098

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18105

Country

United States

Facility Name

Local Institution - 0016

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Local Institution - 0021

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Erlanger Oncology & Hematology - Univ. of TN

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

Local Institution - 0008

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Local Institution - 0025

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8852

Country

United States

Facility Name

Local Institution - 0009

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Local Institution - 0005

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Local Institution - 0049

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Local Institution - 0052

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 0050

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution - 0051

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Local Institution - 0122

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Local Institution - 0062

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution - 0061

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution - 0070

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Local Institution - 0069

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution - 0071

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution - 0046

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Local Institution - 0048

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0047

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Local Institution - 0084

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Local Institution - 0085

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution - 0043

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution - 0041

City

Lyon Cedex 03

ZIP/Postal Code

69394

Country

France

Facility Name

Local Institution - 0040

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Local Institution - 0042

City

Nancy

ZIP/Postal Code

54035

Country

France

Facility Name

Local Institution - 0039

City

Paris cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Local Institution - 0038

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Local Institution - 0044

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Local Institution - 0045

City

Toulouse

ZIP/Postal Code

31100

Country

France

Facility Name

Local Institution - 0055

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Local Institution - 0123

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Local Institution - 0053

City

Frankfurt Am Main

ZIP/Postal Code

60528

Country

Germany

Facility Name

Local Institution - 0124

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Local Institution - 0057

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Local Institution - 0056

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution - 0131

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Local Institution - 0054

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Local Institution - 0130

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 0058

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Local Institution - 0059

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution - 0094

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution - 0093

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution - 0088

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

Local Institution - 0089

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0092

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution - 0127

City

Rozzano (milano)

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution - 0090

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution - 0091

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution - 0110

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

4668560

Country

Japan

Facility Name

Local Institution - 0099

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

2608677

Country

Japan

Facility Name

Local Institution - 0100

City

Hiroshima-Shi

State/Province

Hiroshima

ZIP/Postal Code

7348551

Country

Japan

Facility Name

Local Institution - 0101

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0105

City

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Local Institution - 0116

City

Tsukuba-shi

State/Province

Ibaraki

ZIP/Postal Code

3058576

Country

Japan

Facility Name

Local Institution - 0103

City

Kanazawa-shi

State/Province

Ishikawa

ZIP/Postal Code

9200934

Country

Japan

Facility Name

Local Institution - 0102

City

Kagoshima-shi

State/Province

Kagoshima

ZIP/Postal Code

8908520

Country

Japan

Facility Name

Local Institution - 0118

City

Sagamihara-shi

State/Province

Kanagawa

ZIP/Postal Code

2520375

Country

Japan

Facility Name

Local Institution - 0106

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

8608556

Country

Japan

Facility Name

Local Institution - 0120

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Local Institution - 0104

City

Hirakata-shi

State/Province

Osaka

ZIP/Postal Code

5731191

Country

Japan

Facility Name

Local Institution - 0112

City

Suita

State/Province

Osaka

ZIP/Postal Code

5650871

Country

Japan

Facility Name

Local Institution - 0121

City

Hidaka-shi

State/Province

Saitama

ZIP/Postal Code

3501298

Country

Japan

Facility Name

Local Institution - 0114

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138655

Country

Japan

Facility Name

Local Institution - 0111

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Local Institution - 0107

City

Mitaka-shi

State/Province

Tokyo

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

Local Institution - 0115

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

1628666

Country

Japan

Facility Name

Local Institution - 0117

City

Yamagata-shi

State/Province

Yamagata

ZIP/Postal Code

9909585

Country

Japan

Facility Name

Local Institution - 0109

City

Kyoto

ZIP/Postal Code

6068507

Country

Japan

Facility Name

Local Institution - 0108

City

Kyoto

ZIP/Postal Code

612-8555

Country

Japan

Facility Name

Local Institution - 0073

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Local Institution - 0075

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0074

City

Groningen

ZIP/Postal Code

9713 AP

Country

Netherlands

Facility Name

Local Institution - 0072

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Local Institution - 0083

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Local Institution - 0086

City

Gdansk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Local Institution - 0132

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0095

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Local Institution - 0097

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution - 0126

City

Badalona-barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Local Institution - 0078

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0125

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 0077

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Local Institution - 0076

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0080

City

Santiago Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Local Institution - 0079

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Local Institution - 0081

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Local Institution - 0082

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Local Institution - 0065

City

Geneve

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Local Institution - 0064

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Local Institution - 0063

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 0066

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0119

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution - 0068

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution - 0067

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35511454

Citation

Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.

Results Reference

derived

PubMed Identifier

32691060

Citation

Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

Investigator Inquiry Form

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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)

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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) (CheckMate548)

Brain Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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