A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

Official Title
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A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: BMS-986449
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant. Part 1A may have a solid malignancy of any histology. Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC). Part 1C is restricted to participants with Triple-negative breast cancer (TNBC). Tumor biopsy must be obtained for all participants (unless medically precluded). Exclusion Criteria: History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures. Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention. Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. Other protocol-defined criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation: BMS-986449 monotherapy<br> | Drug: BMS-986449<br>* Specified dose on specified days<br>|
| Experimental: Dose Escalation: BMS-986449 + nivolumab<br> | Drug: BMS-986449<br>* Specified dose on specified days<br>Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts<br> | Drug: BMS-986449<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Dose-Limiting Toxicities (DLTs) |  | Up to approximately 4 years | 
| Number of participants with Adverse Events (AEs) |  | Up to approximately 4 years | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to approximately 4 years | 
| Number of participants with AEs leading to discontinuation |  | Up to approximately 4 years | 
| Number of deaths |  | Up to approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to approximately 4 years | 
| Time of maximum observed concentration within a dosing interval (Tmax) |  | Up to approximately 4 years | 
| Area under the concentration-time curve within a dosing interval (AUC[TAU]) |  | Up to approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986449, Nivolumab, Cancer, Solid Tumors, Non-Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)