NCT05407675|CompletedPhase 1ResultsFDA Drug

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 of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

CA099-003

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredJun 2022

StartedAug 2022

CompletionJul 2025

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Aug 2022

Typical duration for phase_1

Geographic Reach

5 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

June 2, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

August 2, 2022

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed

2 months until next milestone

Results Posted

Study results publicly available

October 3, 2025

Completed

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

June 2, 2022

Results QC Date

August 19, 2025

Last Update Submit

September 16, 2025

Conditions

Advanced Solid Tumors

Keywords

CancerOncologyPhase 1Solid Tumor

Outcome Measures

Primary Outcomes (3)

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

Study Arms (7)

Part 1: BMS-986408 Monotherapy

EXPERIMENTAL

Drug: BMS-986408

Part 2: BMS-986408 in combination with nivolumab

EXPERIMENTAL

Drug: BMS-986408Biological: Nivolumab

Part 2: BMS-986408 in combination with nivolumab and ipilimumab

EXPERIMENTAL

Drug: BMS-986408Biological: NivolumabBiological: Ipilimumab

Part 2: BMS-986408 in combination with nivolumab and chemotherapy

EXPERIMENTAL

Drug: BMS-986408Biological: NivolumabBiological: Platinum-doublet chemotherapy

Part 2: BMS-986408 in combination with rabeprazole

EXPERIMENTAL

Drug: BMS-986408Drug: Rabeprazole

Part 3: BMS-986408 in combination with nivolumab

EXPERIMENTAL

Drug: BMS-986408Biological: Nivolumab

Part 3: BMS-986408 in combination with nivolumab and chemotherapy

EXPERIMENTAL

Drug: BMS-986408Biological: NivolumabBiological: Platinum-doublet chemotherapy