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CompletedNCT02667587CheckMate548Updated Jun 18, 2025Results posted

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)

A Phase 3 interventional study of Nivolumab and Temozolomide in Brain Neoplasms, sponsored by Bristol-Myers Squibb. Completed at 123 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
716
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Neoplasms
03

In context

Glioblastoma

1,921 studies on the registry are indexed under Glioblastoma; 451 are open to participants now.

This study's enrollment of 716 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Inclusion criteria

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

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
716 participants (actual)

Study arms

  • Experimental
    Nivolumab + Temozolomide + Radiotherapy

    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

    Drug: Nivolumab · Drug: Temozolomide · Radiation: Radiotherapy

  • Placebo comparator
    Nivolumab placebo + Temozolomide + Radiotherapy

    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

    Drug: Temozolomide · Radiation: Radiotherapy · Other: Nivolumab Placebo

Interventions

  • DrugNivolumab

    Also known as: Opdivo, Nivo, N, BMS-936558

  • DrugTemozolomide

    Also known as: Temodar, TMZ, Temodal, Temcad

  • RadiationRadiotherapy

    Also known as: RT

  • OtherNivolumab Placebo
06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Overall Survival (OS) Rates at 12 Months

    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

  2. Overall Survival (OS) Rates at 24 Months

    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

  3. 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.

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

07

Results

Posted Feb 3, 2022

Participant flow

Pre-Treatment
Participant flow — Pre-Treatment
MilestoneRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Started358358
Completed354355
Not completed43
Withdrew: Not reported10
Withdrew: Participant no longer meets study criteria22
Withdrew: Participant withdrew consent01
Withdrew: Adverse event unrelated to study drug10
End of Treatment
Participant flow — End of Treatment
MilestoneRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Started355354
Completed00
Not completed355354
Withdrew: Disease progression193226
Withdrew: Study drug toxicity7519
Withdrew: Death21
Withdrew: Adverse event unrelated to study drug1920
Withdrew: Participant request to discontinue treatment3335
Withdrew: Participant withdrew consent56
Withdrew: Lost to follow-up12
Withdrew: Maximum clinical benefit44
Withdrew: Poor or non compliant01
Withdrew: Participant no longer meets study criteria11
Withdrew: Administrative reason by sponsor129
Withdrew: Other reasonse2110

Outcome measures

PrimaryProgression-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.

Time frame:
From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Reported as:
Median · Months
Progression-free Survival (PFS) Determined by BICR
MonthsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Progression-free Survival (PFS) Determined by BICR10.64 (8.90 to 11.79)10.32 (9.69 to 12.45)
Statistical analysis
  • Radiotherapy, Temozolomide Plus Nivolumab · Cox proportional hazard: 1.06 · 95% CI 0.90 to 1.25
PrimaryOverall 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.

Time frame:
From randomization to date of death (up to approximately 4.5 years)
Reported as:
Median · Months
Overall Survival (OS)
MonthsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
All randomized participants28.91 (24.38 to 31.57)32.07 (29.37 to 33.77)
All randomized participants without baseline corticosteroids31.34 (28.62 to 34.76)32.99 (31.01 to 35.09)
Statistical analysis
  • Radiotherapy, Temozolomide Plus Nivolumab · Log Rank · p = 0.3402 · Cox proportional hazard: 1.12 · 96.39% CI 0.87 to 1.43
  • Radiotherapy, Temozolomide Plus Nivolumab · Cox proportional hazard: 1.10 · 95% CI 0.91 to 1.33
SecondaryOverall Survival (OS) Rates at 12 Months

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
Reported as:
Number · percentage of participants
Overall Survival (OS) Rates at 12 Months
percentage of participantsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Overall Survival (OS) Rates at 12 Months82.7 (78.3 to 86.3)87.7 (83.8 to 90.8)
SecondaryOverall Survival (OS) Rates at 24 Months

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
Reported as:
Number · percentage of participants
Overall Survival (OS) Rates at 24 Months
percentage of participantsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Overall Survival (OS) Rates at 24 Months55.9 (50.5 to 61.0)63.3 (58 to 68.2)
SecondaryProgression 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.

Time frame:
From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Reported as:
Median · Months
Progression Free Survival (PFS) Based on Investigator Assessment
MonthsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Progression Free Survival (PFS) Based on Investigator Assessment14.09 (12.62 to 16.56)15.18 (13.11 to 17.12)
Post-hocProgression-free Survival (PFS) Determined by BICR - Extended Collection

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.

Time frame:
From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 82 Months)
Reported as:
Median · Months
Progression-free Survival (PFS) Determined by BICR - Extended Collection
MonthsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Progression-free Survival (PFS) Determined by BICR - Extended Collection9.89 (8.31 to 11.60)10.25 (9.46 to 12.09)
Statistical analysis
  • Radiotherapy, Temozolomide Plus Nivolumab · Cox proportional hazard: 1.18 · 95% CI 0.99 to 1.40
Post-hocOverall Survival (OS) - Extended Collection

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.

Time frame:
From randomization to date of death (up to approximately 82 Months)
Reported as:
Median · Months
Overall Survival (OS) - Extended Collection
MonthsRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Overall Survival (OS) - Extended Collection28.94 (24.57 to 31.64)31.84 (28.94 to 33.77)
Statistical analysis
  • Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo · Log Rank · Cox proportional hazard: 1.06 · 95% CI 0.89 to 1.26

Adverse events

Collected over Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Radiotherapy, Temozolomide Plus Nivolumab263/358 (73.5%)259/355 (73%)351/355 (98.9%)
Radiotherapy, Temozolomide Plus Placebo255/358 (71.2%)217/354 (61.3%)343/354 (96.9%)
Most frequent serious events
Showing 10 of 281
Most frequent serious events
EventRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)75/35573/354
SeizureNervous system disorders48/35540/354
PyrexiaGeneral disorders16/3554/354
EpilepsyNervous system disorders15/35512/354
PneumoniaInfections and infestations14/3555/354
Pulmonary embolismRespiratory, thoracic and mediastinal disorders9/35513/354
GlioblastomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)7/35512/354
Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)6/35511/354
Tumour flareNeoplasms benign, malignant and unspecified (incl cysts and polyps)10/3557/354
HydrocephalusNervous system disorders10/3559/354
Most frequent other events
Showing 10 of 70
Most frequent other events
EventRadiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus Placebo
NauseaGastrointestinal disorders187/355159/354
FatigueGeneral disorders186/355176/354
ConstipationGastrointestinal disorders163/355145/354
HeadacheNervous system disorders142/355135/354
AlopeciaSkin and subcutaneous tissue disorders115/355109/354
Decreased appetiteMetabolism and nutrition disorders97/35587/354
VomitingGastrointestinal disorders90/35575/354
PruritusSkin and subcutaneous tissue disorders86/35577/354
RashSkin and subcutaneous tissue disorders85/35558/354
DiarrhoeaGastrointestinal disorders77/35572/354

Baseline characteristics

Demographic characteristics are based off all randomized participants

Age, Continuous
Age, Continuous(Years)Radiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus PlaceboTotal
Mean57.9 ± 12.258.7 ± 11.458.3 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)Radiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus PlaceboTotal
Female153161314
Male205197402
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Radiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus PlaceboTotal
Hispanic or Latino71118
Not Hispanic or Latino171178349
Unknown or Not Reported180169349
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Radiotherapy, Temozolomide Plus NivolumabRadiotherapy, Temozolomide Plus PlaceboTotal
White301318619
Black or African American448
Asian353368
Other17320
Not Reported101
08

Study locations

123 sites
  • Local Institution - 0023
    Birmingham, Alabama 35294-3410, United States
  • Local Institution - 0003
    Phoenix, Arizona 85013, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Local Institution - 0010
    Los Angeles, California 90095-1769, United States
  • Local Institution - 0128
    Sacramento, California 95816, United States
  • Local Institution - 0029
    San Diego, California 92123, United States
  • Local Institution - 0006
    San Francisco, California 94143-0372, United States
  • Local Institution - 0004
    New Haven, Connecticut 06520, United States
  • Local Institution - 0031
    Washington, District of Columbia 20007, United States
  • Local Institution - 0087
    Miami, Florida 33136, United States
  • Local Institution - 0030
    Tampa, Florida 33612, United States
  • Local Institution - 0022
    Chicago, Illinois 60637, United States
  • Local Institution - 0060
    Westwood, Kansas 66205, United States
  • Local Institution - 0018
    Louisville, Kentucky 40202, United States
  • Local Institution - 0020
    Baltimore, Maryland 21287, United States
  • Local Institution - 0011
    Boston, Massachusetts 02215, United States
  • Local Institution - 0028
    Boston, Massachusetts 02215, United States
  • Local Institution - 0035
    Detroit, Michigan 48202, United States
  • Local Institution - 0002
    Saint Louis, Missouri 63110, United States
  • Local Institution - 0017
    Edison, New Jersey 08820, United States
  • Local Institution - 0012
    Hackensack, New Jersey 07601, United States
  • Local Institution - 0015
    New York, New York 10032, United States
  • Local Institution - 0024
    New York, New York 10065, United States
  • Local Institution - 0032
    Charlotte, North Carolina 28204, United States
  • Preston Robert Tisch Brain Tumor Center at Duke University
    Durham, North Carolina 27710, United States
  • Local Institution - 0001
    Cleveland, Ohio 44195, United States
  • Local Institution - 0027
    Columbus, Ohio 43210, United States
  • Local Institution - 0098
    Allentown, Pennsylvania 18103, United States
  • Local Institution - 0016
    Philadelphia, Pennsylvania 19107, United States
  • Local Institution - 0021
    Charleston, South Carolina 29425, United States
  • Erlanger Oncology & Hematology - Univ. of TN
    Chattanooga, Tennessee 37403, United States
  • Local Institution - 0008
    Nashville, Tennessee 37232, United States
  • Local Institution - 0025
    Dallas, Texas 75390-8575, United States
  • Local Institution - 0009
    Salt Lake City, Utah 84112, United States
  • Local Institution - 0005
    Seattle, Washington 98122, United States
  • Local Institution - 0049
    Liverpool, New South Wales 2170, Australia
  • Local Institution - 0052
    St. Leonards, New South Wales 2065, Australia
  • Local Institution - 0050
    Heidelberg, Victoria 3084, Australia
  • Local Institution - 0051
    Prahran, Victoria 3181, Australia
  • Local Institution - 0122
    Nedlands, Western Australia 6009, Australia
  • Local Institution - 0062
    Linz, 4020, Austria
  • Local Institution - 0061
    Vienna, 1090, Austria
  • Local Institution - 0070
    Brussels, 1090, Belgium
  • Local Institution - 0069
    Bruxelles, 1200, Belgium
  • Local Institution - 0071
    Leuven, 3000, Belgium
  • Local Institution - 0046
    Vancouver, British Columbia V5Z 4E6, Canada
  • Local Institution - 0048
    Toronto, Ontario M5G 2M9, Canada
  • Local Institution - 0047
    Montreal, Quebec H3A 2B4, Canada
  • Local Institution - 0084
    Copenhagen, 2100, Denmark
  • Local Institution - 0085
    Odense, 5000, Denmark
  • Local Institution - 0043
    Lille Cedex, 59037, France
  • Local Institution - 0041
    Lyon Cedex 03, 69394, France
  • Local Institution - 0040
    Marseille, 13385, France
  • Local Institution - 0042
    Nancy, 54035, France
  • Local Institution - 0039
    Paris cedex 13, 75651, France
  • Local Institution - 0038
    Paris, 75010, France
  • Local Institution - 0044
    Rennes Cedex, 35042, France
  • Local Institution - 0045
    Toulouse, 31100, France
  • Local Institution - 0055
    Bonn, 53127, Germany
  • Local Institution - 0123
    Erlangen, 91054, Germany
  • Local Institution - 0053
    Frankfurt Am Main, 60528, Germany
  • Local Institution - 0124
    Freiburg, 79106, Germany
  • Local Institution - 0057
    Hamburg, 20246, Germany
  • Local Institution - 0056
    Heidelberg, 69120, Germany
  • Local Institution - 0131
    Koeln, 50937, Germany
  • Local Institution - 0054
    Muenster, 48149, Germany
  • Local Institution - 0130
    Munich, 81675, Germany
  • Local Institution - 0058
    Regensburg, 93053, Germany
  • Local Institution - 0059
    Tuebingen, 72076, Germany
  • Local Institution - 0094
    Petach Tikva, 49100, Israel
  • Local Institution - 0093
    Tel Aviv, 64239, Israel
  • Local Institution - 0088
    Bologna, 40139, Italy
  • Local Institution - 0089
    Milano, 20133, Italy
  • Local Institution - 0092
    Padova, 35128, Italy
  • Local Institution - 0127
    Rozzano (milano), 20089, Italy
  • Local Institution - 0090
    Siena, 53100, Italy
  • Local Institution - 0091
    Torino, 10126, Italy
  • Local Institution - 0110
    Nagoya-shi, Aichi 4668560, Japan
  • Local Institution - 0099
    Chiba-shi, Chiba 2608677, Japan
  • Local Institution - 0100
    Hiroshima-Shi, Hiroshima 7348551, Japan
  • Local Institution - 0101
    Sapporo-shi, Hokkaido 0608648, Japan
  • Local Institution - 0105
    Kobe-shi, Hyogo 650-0017, Japan
  • Local Institution - 0116
    Tsukuba-shi, Ibaraki 3058576, Japan
  • Local Institution - 0103
    Kanazawa-shi, Ishikawa 9200934, Japan
  • Local Institution - 0102
    Kagoshima-shi, Kagoshima 8908520, Japan
  • Local Institution - 0118
    Sagamihara-shi, Kanagawa 2520375, Japan
  • Local Institution - 0106
    Kumamoto-shi, Kumamoto 8608556, Japan
  • Local Institution - 0120
    Okayama-shi, Okayama 7008558, Japan
  • Local Institution - 0104
    Hirakata-shi, Osaka 5731191, Japan
  • Local Institution - 0112
    Suita, Osaka 5650871, Japan
  • Local Institution - 0121
    Hidaka-shi, Saitama 3501298, Japan
  • Local Institution - 0114
    Bunkyo-ku, Tokyo 1138655, Japan
  • Local Institution - 0111
    Chuo-ku, Tokyo 1040045, Japan
  • Local Institution - 0107
    Mitaka-shi, Tokyo 181-8611, Japan
  • Local Institution - 0115
    Shinjuku-ku, Tokyo 1628666, Japan
  • Local Institution - 0117
    Yamagata-shi, Yamagata 9909585, Japan
  • Local Institution - 0109
    Kyoto, 6068507, Japan
  • Local Institution - 0108
    Kyoto, 612-8555, Japan
  • Local Institution - 0073
    Rotterdam, Zuid-Holland 3015 GD, Netherlands
  • Local Institution - 0075
    Amsterdam, 1066 CX, Netherlands

Showing the first 100 of 123 sites across 19 countries.

09

References and documents

Publications

  • 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. PubMed 35511454 ↗
  • 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. PubMed 32691060 ↗

Study documents

  • Study protocol · Sep 2, 2021
  • Statistical analysis plan · Mar 29, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02667587
Lead sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
May 9, 2016
Primary completion
Dec 22, 2020
Completion
Apr 9, 2024
Results posted
Feb 3, 2022
Last update
Jun 18, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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