NCT03130959 (CheckMate 908) is a Phase 2 clinical trial of Nivolumab in Various Advanced Cancer, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03130959?

NCT03130959 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03130959?

Interventions in NCT03130959: Nivolumab, Ipilimumab.

What condition does NCT03130959 study?

NCT03130959 studies Various Advanced Cancer.

Is NCT03130959 still recruiting?

NCT03130959 is currently completed. Last updated 9 August 2022.

Are results published for NCT03130959?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-09 · How we verify

NCT03130959: CheckMate 908

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

Completed Phase 2 Results posted Last updated 9 August 2022

What this trial tests

Phase 2 trial testing Nivolumab in Various Advanced Cancer in 166 participants. Completed in 17 January 2022.

Timeline

12 June 2017

Primary endpoint
10 March 2020

17 January 2022

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	12 June 2017
Primary completion	10 March 2020
Estimated completion	17 January 2022
Sites	54 locations across France, Hong Kong, Netherlands, Russia, Sweden, United Kingdom, Germany, Israel

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Ipilimumab — full drug profile →

Conditions studied

Various Advanced Cancer — all drugs for Various Advanced Cancer →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 6 Months to 21, any sex, with Various Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) Primary · up to 6 weeks post-dosing

A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).

Group	Value	95% CI
Arm A1, Safety Lead-in	0
Arms A2-A5, Safety Lead-in	0
Arms B2-B5, Safety Lead-in	0

Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) Primary · up to 6 weeks post-dosing

The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.

Group	Value	95% CI
Arm A1, Safety Lead-in	7
Arms A2-A5, Safety Lead-in	6
Arms B2-B5, Safety Lead-in	8

Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation Primary · From first dose to 30 days post-last dose (up to approximately 6 weeks)

The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.

Group	Value	95% CI
Arm A1, Safety Lead-in	3
Arms A2-A5, Safety Lead-in	4
Arms B2-B5, Safety Lead-in	2

Overall Survival (OS), Cohort 1 Only Primary · up to approximately 42 months

Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.

Group	Value	95% CI
Arm A1	11.66	10.32 – 16.46
Arm B1	10.78	9.13 – 15.77

Progression-Free Survival (PFS), Cohorts 2-4 Primary · up to approximately 42 months

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Group	Value	95% CI
Arm A2	1.74	1.35 – 2.73
Arm B2	1.31	1.18 – 1.45
Arm A3	1.38	1.22 – 1.38
Arm B3	2.76	1.48 – 4.53
Arm A4	1.41	1.41 – 2.60
Arm B4	4.60	1.41 – 5.39

Progression-Free Survival (PFS), Cohort 5 Only Primary · up to approximately 42 months

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Group	Value	95% CI
Arm A5	1.22	1.08 – 1.31
Arm B5	1.61	1.31 – 3.45

Progression-Free Survival (PFS), Cohort 1 Only Secondary · From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Progression is defined as: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement * Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor * Failure to return for evaluati

Group	Value	95% CI
Arm A1	6.21	3.75 – 6.54
Arm B1	4.53	2.99 – 6.44

Overall Survival at 12 Months (OS12), Cohorts 1-4 Secondary · From first dose to up to 12 months after first dose

Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.

Group	Value	95% CI
Arm A1	47.3	25.2 – 66.5
Arm B1	42.9	21.9 – 62.3
Arm A2	37.5	15.4 – 59.8
Arm B2	32.8	10.5 – 57.6
Arm A3	38.9	14.3 – 63.2
Arm B3	86.7	56.4 – 96.5
Arm A4	41.7	15.2 – 66.5
Arm B4	44.4	13.6 – 71.9

Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5 Secondary · From first dose to up to 6 months after first dose

Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free. Progression is defined as: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement * Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids * An

Group	Value	95% CI
Arm A2	9.4	0.7 – 31.8
Arm B2	14.3	2.3 – 36.6
Arm A3	0	NA – NA
Arm B3	20.0	4.9 – 42.4
Arm A4	20.0	3.1 – 47.5
Arm B4	11.4	0.6 – 39.5
Arm A5	5.3	0.4 – 21.4
Arm B5	14.0	2.8 – 34.1

Overall Survival (OS), Cohorts 2-5 Secondary · From first dose to the date of death (up to approximately 55 months)

Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.

Group	Value	95% CI
Arm A2	6.67	2.99 – 14.62
Arm B2	6.47	2.14 – 13.17
Arm A3	7.36	2.46 – 30.23
Arm B3	22.21	13.77 – NA
Arm A4	5.70	1.81 – NA
Arm B4	9.82	2.50 – NA
Arm A5	5.91	1.97 – 7.98
Arm B5	8.48	3.45 – 17.28

Number of Treated Participants With Adverse Events (AEs) Secondary · From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

The number of treated participants who experienced an Adverse Event (AE) during the course of the study. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.

Group	Value	95% CI
Arm A1	23
Arm B1	21
Arm A2	15
Arm B2	14
Arm A3	14
Arm B3	15
Arm A4	12
Arm B4	10
Arm A5	18
Arm B5	18

Number of Treated Participants With Serious Adverse Events (SAEs) Secondary · From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study. SAE is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event Note: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of

Group	Value	95% CI
Arm A1	10
Arm B1	14
Arm A2	10
Arm B2	9
Arm A3	6
Arm B3	7
Arm A4	7
Arm B4	5
Arm A5	13
Arm B5	14

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A1

Serious: 17/23 (74%)

Deaths: 18/23

Arm B1

Serious: 16/22 (73%)

Deaths: 18/22

Arm A2

Serious: 13/16 (81%)

Deaths: 12/16

Arm B2

Serious: 12/15 (80%)

Deaths: 13/15

Arm A3

Serious: 7/15 (47%)

Deaths: 12/15

Arm B3

Serious: 10/15 (67%)

Deaths: 11/15

Arm A4

Serious: 11/12 (92%)

Deaths: 9/12

Arm B4

Serious: 6/10 (60%)

Deaths: 7/10

Arm A5

Serious: 14/19 (74%)

Deaths: 18/19

Arm B5

Serious: 15/19 (79%)

Deaths: 15/19

Serious adverse events (103 terms)

Reaction	System	Arm A1	Arm B1	Arm A2	Arm B2	Arm A3	Arm B3	Arm A4	Arm B4	Arm A5	Arm B5
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Hydrocephalus	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Intracranial pressure increased	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastric ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Immune-mediated enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—
Autoimmune hepatitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (361 terms — click to expand)

Reaction	System	Arm A1	Arm B1	Arm A2	Arm B2	Arm A3	Arm B3	Arm A4	Arm B4	Arm A5	Arm B5
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Hemiparesis	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Ataxia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gait disturbance	General disorders	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Diplopia	Eye disorders	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Blood thyroid stimulating hormone increased	Investigations	—	—	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Hydrocephalus, Vomiting, Tumour flare, Colitis, Diarrhoea, Nausea, Pyrexia.

Data from ClinicalTrials.gov NCT03130959 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

PD-1/PD-L1 in Cancer: Pathophysiological, Diagnostic and Therapeutic Aspects.
Munari E, Mariotti FR, Quatrini L, Bertoglio P, et al · · 2021 · cited 91× · PMID 34066087 · DOI 10.3390/ijms22105123
TIM-3 blockade in diffuse intrinsic pontine glioma models promotes tumor regression and antitumor immune memory.
Ausejo-Mauleon I, Labiano S, de la Nava D, Laspidea V, et al · · 2023 · cited 88× · PMID 37802053 · DOI 10.1016/j.ccell.2023.09.001
A H3K27M-targeted vaccine in adults with diffuse midline glioma.
Grassl N, Poschke I, Lindner K, Bunse L, et al · · 2023 · cited 70× · PMID 37735561 · DOI 10.1038/s41591-023-02555-6
The intrinsic and microenvironmental features of diffuse midline glioma: Implications for the development of effective immunotherapeutic treatment strategies.
Persson ML, Douglas AM, Alvaro F, Faridi P, et al · · 2022 · cited 58× · PMID 35481923 · DOI 10.1093/neuonc/noac117
PD-L1 expression in medulloblastoma: an evaluation by subgroup.
Martin AM, Nirschl CJ, Polanczyk MJ, Bell WR, et al · · 2018 · cited 49× · PMID 29721192 · DOI 10.18632/oncotarget.24951
Opportunities and Challenges in Drug Development for Pediatric Cancers.
Laetsch TW, DuBois SG, Bender JG, Macy ME, et al · · 2021 · cited 45× · PMID 33277309 · DOI 10.1158/2159-8290.cd-20-0779
Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908.
Dunkel IJ, Doz F, Foreman NK, Hargrave D, et al · · 2023 · cited 41× · PMID 36808285 · DOI 10.1093/neuonc/noad031
Immunotherapy for pediatric brain tumors: past and present.
Foster JB, Madsen PJ, Hegde M, Ahmed N, et al · · 2019 · cited 40× · PMID 31504801 · DOI 10.1093/neuonc/noz077

Verify or expand the search:

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Trials testing the same drug.

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Other recruiting trials for Various Advanced Cancer

Currently open trials in the same condition.

NCT02632409 — An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tra · Phase 3 · active not recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03130959 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 9 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03130959.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing