CompletedNCT05407675Updated Aug 13, 2026Results posted

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

A Phase 1/2 interventional study of BMS-986408 and Nivolumab in Advanced Solid Tumors, sponsored by Bristol-Myers Squibb. Completed at 18 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 68
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Conditions studied

Advanced Solid Tumors

Browse trials for

Neoplasms 9,365

Keywords

Cancer
Oncology
Phase 1
Solid Tumor

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms 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.

Who can participate

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

Inclusion criteria

Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion criteria

Exclusion Criteria:

An active, known or suspected autoimmune disease
Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 68 participants (actual)

Study arms

Experimental
Part 1: BMS-986408 Monotherapy
Drug: BMS-986408
Experimental
Part 2: BMS-986408 in combination with nivolumab
Drug: BMS-986408 · Biological: Nivolumab
Experimental
Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Drug: BMS-986408 · Biological: Nivolumab · Biological: Ipilimumab
Experimental
Part 2: BMS-986408 in combination with nivolumab and chemotherapy
Drug: BMS-986408 · Biological: Nivolumab · Biological: Platinum-doublet chemotherapy
Experimental
Part 2: BMS-986408 in combination with rabeprazole
Drug: BMS-986408 · Drug: Rabeprazole
Experimental
Part 3: BMS-986408 in combination with nivolumab
Drug: BMS-986408 · Biological: Nivolumab
Experimental
Part 3: BMS-986408 in combination with nivolumab and chemotherapy
Drug: BMS-986408 · Biological: Nivolumab · Biological: Platinum-doublet chemotherapy

Interventions

DrugBMS-986408
Specified dose on specified days
BiologicalNivolumab
Specified dose on specified days
Also known as: Opdivo, BMS-936558
BiologicalIpilimumab
Specified dose on specified days
Also known as: Yervoy, BMS-734016
BiologicalPlatinum-doublet chemotherapy
Specified dose on specified days
Also known as: PDCT, carbplatin, paclitaxel, pemetrexed, cisplatin
DrugRabeprazole
Specified dose on specified days

What researchers measure

Primary outcomes

Number of Participants With Dose Limiting Toxicities (DLTs)
A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia \>7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Time frame: From first dose (Day 1) till 28 days
Number of Participants With Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D
Number of Participants Who Died
Time frame: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)

Secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of BMS-986408
Blood samples were collected to assess pharmacokinetic parameters
Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408
Blood samples were collected to assess pharmacokinetic parameters
Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)]
Blood samples were collected to assess pharmacokinetic parameters.
Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Objective Response Rate (ORR) Per RECIST v1.1
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)
Duration of Response Per RECIST v1.1
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)

Results

Posted Oct 3, 2025

Participant flow

Participant flow — Overall Study
Milestone	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Started	3	6	7	11	3	4	5	2	6	7	8	5	1
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0
Not completed	3	6	7	11	3	4	5	2	6	7	8	5	1
Withdrew: Withdrawal by subject	0	2	3	5	0	2	0	0	2	0	1	0	0
Withdrew: Site terminated by sponsor	0	0	1	0	2	0	1	0	1	2	2	2	1
Withdrew: Disease progression	0	0	0	0	0	0	0	0	0	0	1	0	0
Withdrew: Physician decision	0	0	0	0	0	0	0	0	0	0	1	0	0
Withdrew: Other reasons	0	0	0	0	0	0	0	0	1	1	1	1	0
Withdrew: Death	3	4	3	6	0	2	4	2	2	4	2	1	0
Withdrew: Adverse event	0	0	0	0	1	0	0	0	0	0	0	1	0

Outcome measures

PrimaryNumber of Participants With Dose Limiting Toxicities (DLTs)

A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia \>7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

Time frame:: From first dose (Day 1) till 28 days
Reported as:: Count of participants · Participants

Number of Participants With Dose Limiting Toxicities (DLTs)
Participants	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Number of Participants With Dose Limiting Toxicities (DLTs)	0	0	0	0	0	0	0	0	0	1	0	0	0

PrimaryNumber of Participants With Adverse Events

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame:: From first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events
Participants	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Any Adverse Events	3	6	6	11	3	4	5	2	6	7	8	5	1
Any Drug-related AEs	2	4	3	11	3	4	4	2	3	6	6	5	1
Serious Adverse Events	2	1	2	7	2	3	4	2	4	3	3	3	1
AEs leading to Discontinuation	0	0	1	1	1	0	0	0	0	3	0	3	0

SecondaryMaximum Observed Plasma Concentration (Cmax) of BMS-986408

Blood samples were collected to assess pharmacokinetic parameters

Time frame:: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Reported as:: Geometric mean · nanogram per mililitre (ng/mL)

Maximum Observed Plasma Concentration (Cmax) of BMS-986408
nanogram per mililitre (ng/mL)	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Cycle 1 Day 1	2.49 ± 61.05	4.86 ± 37.36	8.56 ± 35.16	15.00 ± 45.02	15.99 ± 64.67	5.57 ± 34.38	9.98 ± 21.58	11.20 ± NA	12.62 ± 37.65	19.43 ± 41.43	5.07 ± 36.26	10.71 ± 46.81	15.50 ± NA
Cycle 1 Day 15	9.32 ± 63.71	17.66 ± 36.70	22.19 ± 51.79	62.97 ± 80.05	41.27 ± 26.51	33.14 ± 61.85	67.55 ± 40.90	30.10 ± NA	28.43 ± 39.76	61.55 ± 32.92	—	—	—

SecondaryTime to Maximum Observed Plasma Concentration (Tmax) of BMS-986408

Blood samples were collected to assess pharmacokinetic parameters

Time frame:: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Reported as:: Geometric mean · hours

Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408
hours	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Cycle 1 Day 1	2.52 ± 42.77	4.62 ± 23.00	4.22 ± 39.23	4.28 ± 43.77	5.38 ± 20.62	4.11 ± 3.08	3.57 ± 27.06	4.17 ± NA	3.19 ± 37.90	4.84 ± 21.23	3.90 ± 48.23	4.75 ± 22.10	5.97 ± NA
Cycle 1 Day 15	2.56 ± 90.49	4.02 ± 62.27	4.72 ± 89.13	3.12 ± 62.02	2.96 ± 115.92	3.71 ± 59.62	2.45 ± 28.62	2.10 ± NA	2.83 ± 41.44	4.14 ± 2.57	—	—	—

SecondaryArea Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)]

Blood samples were collected to assess pharmacokinetic parameters.

Time frame:: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Reported as:: Geometric mean · ng*h/mL

Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)]
ng*h/mL	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Cycle 1 Day 1	28.20 ± 195.49	78.06 ± 26.21	127.52 ± 37.45	190.26 ± 65.52	263.11 ± 46.78	21.59 ± 39.75	47.81 ± 25.65	45.09 ± NA	177.07 ± 37.21	275.58 ± 34.92	72.34 ± 26.97	132.88 ± 64.47	255.90 ± NA
Cycle 1 Day 15	188.79 ± 74.03	251.19 ± 83.24	435.29 ± 48.55	1252.68 ± 74.84	492.07 ± 124.61	178.12 ± 67.11	377.22 ± 38.40	170.18 ± NA	360.41 ± 132.44	736.15 ± 131.38	—	—	—

SecondaryObjective Response Rate (ORR) Per RECIST v1.1

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame:: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)
Reported as:: Number · percentage of participants

Objective Response Rate (ORR) Per RECIST v1.1
percentage of participants	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Objective Response Rate (ORR) Per RECIST v1.1	0.0 (0.0 to 70.8)	0.0 (0.0 to 45.9)	0.0 (0.0 to 41.0)	0.0 (0.0 to 28.5)	0.0 (0.0 to 70.8)	0.0 (0.0 to 60.2)	0.0 (0.0 to 52.2)	0.0 (0.0 to 84.2)	16.7 (0.4 to 64.1)	0.0 (0.0 to 41.0)	0.0 (0.0 to 36.9)	0.0 (0.0 to 52.2)	0.0 (0.0 to 97.5)

SecondaryDuration of Response Per RECIST v1.1

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame:: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)
Reported as:: Median · months

Duration of Response Per RECIST v1.1
months	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Duration of Response Per RECIST v1.1	—	—	—	—	—	—	—	—	NA (NA to NA)	—	—	—	—

PrimaryNumber of Participants Who Died

Time frame:: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)
Reported as:: Count of participants · Participants

Number of Participants Who Died
Participants	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
Number of Participants Who Died	0	1	1	4	0	3	2	1	1	3	2	1	0

Adverse events

Collected over All-cause mortality was collected from Day 1 and up to 155 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 22 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 24 months) for group D.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 (Group A) BMS-986408 0.75 mg QD	3/3 (100%)	2/3 (66.7%)	3/3 (100%)
Part 1 (Group A) BMS-986408 1.5 mg QD	4/6 (66.7%)	0/6 (0%)	6/6 (100%)
Part 1 (Group A) BMS-986408 3 mg QD	3/7 (42.9%)	2/7 (28.6%)	6/7 (85.7%)
Part 1 (Group A) BMS-986408 5 mg QD	6/11 (54.5%)	7/11 (63.6%)	11/11 (100%)
Part 1 (Group A) BMS-986408 7.25 mg QD	0/3 (0%)	2/3 (66.7%)	3/3 (100%)
Part 1 (Group B) BMS-986408 1.5 mg BID	3/4 (75%)	3/4 (75%)	4/4 (100%)
Part 1 (Group B) BMS-986408 2.25 mg BID	4/5 (80%)	4/5 (80%)	5/5 (100%)
Part 1 (Group B) BMS-986408 3.75 mg BID	2/2 (100%)	2/2 (100%)	2/2 (100%)
Part 1 Group C BMS-986408 3 mg QD	3/6 (50%)	4/6 (66.7%)	6/6 (100%)
Part 1 Group C BMS-986408 5 mg QD	4/7 (57.1%)	3/7 (42.9%)	7/7 (100%)
Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	3/8 (37.5%)	3/8 (37.5%)	8/8 (100%)
Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	2/5 (40%)	3/5 (60%)	5/5 (100%)
Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	0/1 (0%)	1/1 (100%)	1/1 (100%)

Most frequent serious events

Showing 10 of 44

Most frequent serious events
Event	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
PyrexiaGeneral disorders and administration site conditions	0/3	0/6	0/7	1/11	0/3	0/4	0/5	0/2	1/6	0/7	0/8	1/5	1/1
Brain oedemaNervous system disorders	0/3	0/6	0/7	0/11	0/3	0/4	0/5	1/2	0/6	0/7	0/8	0/5	0/1
Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders	0/3	0/6	0/7	0/11	0/3	0/4	1/5	1/2	0/6	0/7	0/8	0/5	0/1
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/3	0/6	0/7	1/11	0/3	0/4	2/5	0/2	0/6	0/7	0/8	0/5	0/1
AnaemiaBlood and lymphatic system disorders	0/3	0/6	0/7	0/11	1/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1
Immune-mediated pancytopeniaBlood and lymphatic system disorders	0/3	0/6	0/7	0/11	1/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1
OsteomyelitisInfections and infestations	0/3	0/6	0/7	0/11	1/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1
HyponatraemiaMetabolism and nutrition disorders	1/3	0/6	0/7	0/11	0/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1
Urinary tract obstructionRenal and urinary disorders	1/3	0/6	0/7	0/11	0/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1
VomitingGastrointestinal disorders	0/3	0/6	0/7	0/11	0/3	1/4	0/5	0/2	0/6	0/7	0/8	0/5	0/1

Most frequent other events

Showing 10 of 179

Most frequent other events
Event	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W
AnaemiaBlood and lymphatic system disorders	1/3	3/6	2/7	2/11	2/3	1/4	2/5	0/2	1/6	4/7	0/8	3/5	1/1
DiarrhoeaGastrointestinal disorders	2/3	1/6	2/7	8/11	3/3	2/4	4/5	2/2	5/6	3/7	3/8	2/5	1/1
NauseaGastrointestinal disorders	1/3	0/6	2/7	5/11	3/3	2/4	3/5	1/2	2/6	3/7	4/8	2/5	0/1
FatigueGeneral disorders and administration site conditions	0/3	1/6	0/7	5/11	2/3	3/4	3/5	1/2	1/6	3/7	3/8	2/5	1/1
PyrexiaGeneral disorders and administration site conditions	1/3	0/6	2/7	5/11	1/3	0/4	0/5	1/2	0/6	2/7	1/8	2/5	1/1
Alanine aminotransferase increasedInvestigations	0/3	0/6	1/7	2/11	1/3	0/4	0/5	0/2	0/6	1/7	0/8	0/5	1/1
Blood alkaline phosphatase increasedInvestigations	1/3	0/6	1/7	1/11	0/3	0/4	0/5	0/2	0/6	2/7	0/8	1/5	1/1
Decreased appetiteMetabolism and nutrition disorders	1/3	1/6	0/7	3/11	2/3	1/4	3/5	2/2	1/6	4/7	4/8	3/5	0/1
DehydrationMetabolism and nutrition disorders	0/3	0/6	0/7	0/11	0/3	0/4	0/5	0/2	0/6	0/7	0/8	0/5	1/1
HypokalaemiaMetabolism and nutrition disorders	0/3	0/6	1/7	1/11	0/3	2/4	0/5	2/2	1/6	1/7	0/8	1/5	0/1

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	Total
Mean	58.7 ± 10.02	57.8 ± 15.41	62.3 ± 13.15	57.4 ± 12.57	67.0 ± 13.08	52.5 ± 10.08	67.0 ± 6.44	70.5 ± 12.02	68.0 ± 6.63	55.9 ± 10.61	62.9 ± 9.11	57.2 ± 13.86	70.0 ± NA	60.8 ± 11.50

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	Total
Female	2	1	4	5	1	3	4	1	3	4	4	1	0	33
Male	1	5	3	6	2	1	1	1	3	3	4	4	1	35

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	Total
Hispanic or Latino	1	2	1	1	1	1	0	0	0	0	0	0	0	7
Not Hispanic or Latino	2	4	6	10	2	3	5	2	3	7	6	4	1	55
Unknown or Not Reported	0	0	0	0	0	0	0	0	3	0	2	1	0	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1 (Group A) BMS-986408 0.75 mg QD	Part 1 (Group A) BMS-986408 1.5 mg QD	Part 1 (Group A) BMS-986408 3 mg QD	Part 1 (Group A) BMS-986408 5 mg QD	Part 1 (Group A) BMS-986408 7.25 mg QD	Part 1 (Group B) BMS-986408 1.5 mg BID	Part 1 (Group B) BMS-986408 2.25 mg BID	Part 1 (Group B) BMS-986408 3.75 mg BID	Part 1 Group C BMS-986408 3 mg QD	Part 1 Group C BMS-986408 5 mg QD	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	3	1	0	0	0	0	0	0	1	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	2	0	0	0	1	0	2	0	0	0	0	5
White	3	5	3	8	2	4	4	2	1	5	7	3	1	48
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	1	2	0	0	0	0	0	3	2	1	1	0	10

Study locations

18 sites

Local Institution - 0010
Boston, Massachusetts 02215, United States
Local Institution - 0001
Hackensack, New Jersey 07601, United States
Local Institution - 0003
Houston, Texas 77030, United States
Local Institution - 0007
Edmonton, Alberta T6G 1Z2, Canada
Local Institution - 0011
Hamilton, Ontario L8V5C2, Canada
Local Institution - 0005
Ottawa, Ontario K1H 8L6, Canada
Local Institution - 0006
Toronto, Ontario M5G 2M9, Canada
Local Institution - 0015
Bordeaux, Aquitaine 33076, France
Local Institution - 0014
Villejuif, Paris 94800, France
Local Institution - 0018
Marseille, 13385, France
Local Institution - 0019
Toulouse, 31059, France
Local Institution - 0024
Málaga, Andalusia 29010, Spain
Local Institution - 0022
Madrid, Madrid 28040, Spain
Local Institution - 0023
Madrid, Madrid 28050, Spain
Local Institution - 0025
Madrid, Madrid, Comunidad de 28009, Spain
Local Institution - 0021
Sankt Gallen, Canton of St. Gallen 9007, Switzerland
Local Institution - 0012
Basel, 4031, Switzerland
Local Institution - 0020
Geneva, 1205, Switzerland

References and documents

Study documents

Protocol and statistical analysis plan · Dec 11, 2023

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05407675
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jun 7, 2022
Start date: Aug 2, 2022
Primary completion: Aug 22, 2024
Completion: Jul 24, 2025
Results posted: Oct 3, 2025
Last update: Aug 13, 2026

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor