Advanced Solid TumorsPhase 1/2NCT05407675

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 study testing BMS-986408, Nivolumab and Ipilimumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: BMS-986408, Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 18 sitesin 5 countries
Study dates: 2 Aug 2022to 24 Jul 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 5 countries.

Country

City, postcode or hospital

18 sites in 5 countries

Canada4 sites

Local Institution - 0007
Edmonton, Alberta, T6G 1Z2
Local Institution - 0011
Hamilton, Ontario, L8V5C2
Local Institution - 0005
Ottawa, Ontario, K1H 8L6
Local Institution - 0006
Toronto, Ontario, M5G 2M9

Other trials in Canada

France4 sites

Local Institution - 0015
Bordeaux, Aquitaine, 33076
Local Institution - 0018
Marseille, 13385
Local Institution - 0019
Toulouse, 31059
Local Institution - 0014
Villejuif, Paris, 94800

Other trials in France

Spain4 sites

Local Institution - 0022
Madrid, Madrid, 28040
Local Institution - 0023
Madrid, Madrid, 28050
Local Institution - 0025
Madrid, Madrid, Comunidad de, 28009
Local Institution - 0024
Málaga, Andalusia, 29010

Other trials in Spain

United States3 sites

Local Institution - 0010
Boston, Massachusetts, 02215
Local Institution - 0001
Hackensack, New Jersey, 07601
Local Institution - 0003
Houston, Texas, 77030

Other trials in United States

Switzerland3 sites

Local Institution - 0012
Basel, 4031
Local Institution - 0020
Geneva, 1205
Local Institution - 0021
Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

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: Advanced Solid Tumors
Being tested: BMS-986408, Nivolumab, Ipilimumab, Platinum-doublet chemotherapy, Rabeprazole
Keywords: Cancer, Oncology, Phase 1, Solid Tumor
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986408Drug
Specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
IpilimumabBiological
Also called Yervoy, BMS-734016
Specified dose on specified days
Platinum-doublet chemotherapyBiological
Also called PDCT, carbplatin, paclitaxel, pemetrexed, cisplatin
Specified dose on specified days
RabeprazoleDrug
Specified dose on specified days

Study groups in NCT05407675
Study group	Role	What they receive
Part 1: BMS-986408 Monotherapy	Experimental	Not described Receives: Drug: BMS-986408
Part 2: BMS-986408 in combination with nivolumab	Experimental	Not described Receives: Drug: BMS-986408; Biological: Nivolumab
Part 2: BMS-986408 in combination with nivolumab and ipilimumab	Experimental	Not described Receives: Drug: BMS-986408; Biological: Nivolumab; Biological: Ipilimumab
Part 2: BMS-986408 in combination with nivolumab and chemotherapy	Experimental	Not described Receives: Drug: BMS-986408; Biological: Nivolumab; Biological: Platinum-doublet chemotherapy
Part 2: BMS-986408 in combination with rabeprazole	Experimental	Not described Receives: Drug: BMS-986408; Drug: Rabeprazole
Part 3: BMS-986408 in combination with nivolumab	Experimental	Not described Receives: Drug: BMS-986408; Biological: Nivolumab
Part 3: BMS-986408 in combination with nivolumab and chemotherapy	Experimental	Not described Receives: Drug: BMS-986408; Biological: Nivolumab; Biological: Platinum-doublet chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)

Secondary outcomes (5)

Maximum Observed Plasma Concentration (Cmax) of BMS-986408
Blood samples were collected to assess pharmacokinetic parameters
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202224 Jul 2025

First posted7 Jun 2022
Study start2 Aug 2022
Primary completion22 Aug 2024
Study completion24 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05407675
Sponsor's protocol ID: CA099-003
Status last verified: Jul 2026
First submitted: 2 Jun 2022
Last updated: 13 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05407675
Acronym / sponsor ID: CA099-003
Conditions: Advanced Solid Tumors
Keywords: Cancer, Oncology, Phase 1, Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 2 Aug 2022 (actual)
Primary completion: 22 Aug 2024 (actual)
Study completion: 24 Jul 2025 (actual)
First posted: 7 Jun 2022 (actual)
Results: Posted 3 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986408Specified dose on specified days	Drug	Part 1: BMS-986408 Monotherapy, Part 2: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and chemotherapy, Part 2: BMS-986408 in combination with nivolumab and ipilimumab, Part 2: BMS-986408 in combination with rabeprazole, Part 3: BMS-986408 in combination with nivolumab, Part 3: BMS-986408 in combination with nivolumab and chemotherapy
NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days	Biological	Part 2: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and chemotherapy, Part 2: BMS-986408 in combination with nivolumab and ipilimumab, Part 3: BMS-986408 in combination with nivolumab, Part 3: BMS-986408 in combination with nivolumab and chemotherapy
IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days	Biological	Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Platinum-doublet chemotherapyAlso: PDCT, carbplatin, paclitaxel, pemetrexed, cisplatinSpecified dose on specified days	Biological	Part 2: BMS-986408 in combination with nivolumab and chemotherapy, Part 3: BMS-986408 in combination with nivolumab and chemotherapy
RabeprazoleSpecified dose on specified days	Drug	Part 2: BMS-986408 in combination with rabeprazole

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From first dose (Day 1) till 28 days
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.
Number of Participants With Adverse Events
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
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.
Number of Participants Who Died
Time frame: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)

5 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of BMS-986408
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
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)]
Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)
Objective Response Rate (ORR) Per RECIST v1.1
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
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 and safety

Results posted to the registry on 3 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 (Group A) BMS-986408 0.75 mg QD	3	0
Part 1 (Group A) BMS-986408 1.5 mg QD	6	0
Part 1 (Group A) BMS-986408 3 mg QD	7	0
Part 1 (Group A) BMS-986408 5 mg QD	11	0
Part 1 (Group A) BMS-986408 7.25 mg QD	3	0
Part 1 (Group B) BMS-986408 1.5 mg BID	4	0
Part 1 (Group B) BMS-986408 2.25 mg BID	5	0
Part 1 (Group B) BMS-986408 3.75 mg BID	2	0
Part 1 Group C BMS-986408 3 mg QD	6	0
Part 1 Group C BMS-986408 5 mg QD	7	0
Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	8	0
Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	5	0
Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	1	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: From first dose (Day 1) till 28 days. Count of participants. Unit: Participants

Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n = 3	Part 1 (Group A) BMS-986408 1.5 mg QD n = 4	Part 1 (Group A) BMS-986408 3 mg QD n = 6	Part 1 (Group A) BMS-986408 5 mg QD n = 9	Part 1 (Group A) BMS-986408 7.25 mg QD n = 3	Part 1 (Group B) BMS-986408 1.5 mg BID n = 3	Part 1 (Group B) BMS-986408 2.25 mg BID n = 4	Part 1 (Group B) BMS-986408 3.75 mg BID n = 2	Part 1 Group C BMS-986408 3 mg QD n = 2	Part 1 Group C BMS-986408 5 mg QD n = 3	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n = 8	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n = 2	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n = 1
Value	0	0	0	0	0	0	0	0	0	1	0	0	0

Population analysed: Participants were DLT evaluable if they received ≥75% of planned BMS-986408 doses without a DLT or had a DLT after at least one dose. In Part 2, they must also have received one nivolumab dose.

Primary outcome: Number of Participants With Adverse Events

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. Count of participants. Unit: Participants

Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n = 3	Part 1 (Group A) BMS-986408 1.5 mg QD n = 6	Part 1 (Group A) BMS-986408 3 mg QD n = 7	Part 1 (Group A) BMS-986408 5 mg QD n = 11	Part 1 (Group A) BMS-986408 7.25 mg QD n = 3	Part 1 (Group B) BMS-986408 1.5 mg BID n = 4	Part 1 (Group B) BMS-986408 2.25 mg BID n = 5	Part 1 (Group B) BMS-986408 3.75 mg BID n = 2	Part 1 Group C BMS-986408 3 mg QD n = 6	Part 1 Group C BMS-986408 5 mg QD n = 7	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n = 8	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n = 5	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n = 1
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

Population analysed: Safety population included all participants who received at least 1 dose of study intervention

Primary outcome: Number of Participants Who Died

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

Measure	Part 1 (Group A) BMS-986408 0.75 mg QD n = 3	Part 1 (Group A) BMS-986408 1.5 mg QD n = 6	Part 1 (Group A) BMS-986408 3 mg QD n = 7	Part 1 (Group A) BMS-986408 5 mg QD n = 11	Part 1 (Group A) BMS-986408 7.25 mg QD n = 3	Part 1 (Group B) BMS-986408 1.5 mg BID n = 4	Part 1 (Group B) BMS-986408 2.25 mg BID n = 5	Part 1 (Group B) BMS-986408 3.75 mg BID n = 2	Part 1 Group C BMS-986408 3 mg QD n = 6	Part 1 Group C BMS-986408 5 mg QD n = 7	Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W n = 8	Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W n = 5	Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W n = 1
Value	0	1	1	4	0	3	2	1	1	3	2	1	0

Population analysed: Safety population included all participants who received at least 1 dose of study intervention

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 (Group A) BMS-986408 0.75 mg QD	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Part 1 (Group A) BMS-986408 1.5 mg QD	0 of 6 (0%)	6 of 6 (100%)	4 of 6
Part 1 (Group A) BMS-986408 3 mg QD	2 of 7 (28.6%)	6 of 7 (85.7%)	3 of 7
Part 1 (Group A) BMS-986408 5 mg QD	7 of 11 (63.6%)	11 of 11 (100%)	6 of 11
Part 1 (Group A) BMS-986408 7.25 mg QD	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Part 1 (Group B) BMS-986408 1.5 mg BID	3 of 4 (75%)	4 of 4 (100%)	3 of 4
Part 1 (Group B) BMS-986408 2.25 mg BID	4 of 5 (80%)	5 of 5 (100%)	4 of 5
Part 1 (Group B) BMS-986408 3.75 mg BID	2 of 2 (100%)	2 of 2 (100%)	2 of 2
Part 1 Group C BMS-986408 3 mg QD	4 of 6 (66.7%)	6 of 6 (100%)	3 of 6
Part 1 Group C BMS-986408 5 mg QD	3 of 7 (42.9%)	7 of 7 (100%)	4 of 7
Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W	3 of 8 (37.5%)	8 of 8 (100%)	3 of 8
Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W	3 of 5 (60%)	5 of 5 (100%)	2 of 5
Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W	1 of 1 (100%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

18 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986408, Nivolumab and Ipilimumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada, France, Spain, United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: From first dose (Day 1) till 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.