Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab 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 BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Official Title
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A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Biological: BMS-986315
* Biological: nivolumab
* Biological: cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1 Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor Eastern cooperative oncology group performance status of 0 or 1 Women of childbearing potential must agree to follow methods of contraception Exclusion Criteria: Participants with active, known or suspected autoimmune disease Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications Uncontrolled or significant cardiovascular disease History of or with active interstitial lung disease or pulmonary fibrosis Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986315<br> | Biological: BMS-986315<br>* Specified dose on specified days<br>|
| Experimental: BMS-986315 + nivolumab<br> | Biological: BMS-986315<br>* Specified dose on specified days<br>Biological: nivolumab<br>* Specified dose on specified days<br>|
| Experimental: BMS-986315 + cetuximab<br> | Biological: BMS-986315<br>* Specified dose on specified days<br>Biological: cetuximab<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 |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to 119 weeks | 
| Incidence of serious adverse events (SAEs) |  | Up to 119 weeks | 
| Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria |  | Up to 119 weeks | 
| Incidence of adverse events (AEs) leading to discontinuation |  | Up to 119 weeks | 
| Number of deaths |  | Up to 119 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Up to 12 months | 
| Duration of Response (DOR) |  | Up to 12 months | 
| Progression-Free Survival Rate (PFSR) |  | Up to 12 months | 
| Maximum observed serum concentration (Cmax) of BMS-986315 |  | Up to 16 weeks | 
| Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab |  | Up to 16 weeks | 
| Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab |  | Up to 16 weeks | 
| Time of maximum observed serum concentration (Tmax) of BMS-986315 |  | Up to 16 weeks | 
| Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab |  | Up to 16 weeks | 
| Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab |  | Up to 16 weeks | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 |  | Up to 16 weeks | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab |  | Up to 16 weeks | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab |  | Up to 16 weeks | 
| Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 |  | Up to 16 weeks | 
| Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab |  | Up to 16 weeks | 
| Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab |  | Up to 16 weeks | 
| Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 |  | Up to 16 weeks | 
| Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab |  | Up to 16 weeks | 
| Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab |  | Up to 16 weeks | 
| Trough observed serum concentrations (Ctrough) of BMS-986315 |  | Up to 119 weeks | 
| Incidence of anti-drug antibodies to BMS-986315 |  | Up to 119 weeks | 
| Incidence of anti-drug antibodies to BMS-986315 with nivolumab |  | Up to 119 weeks | 
| Incidence of anti-drug antibodies to BMS-986315 with cetuximab |  | Up to 119 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC (Non-small cell lung cancer), RCC (Renal cell carcinoma), SCCHN (Squamous cell carcinoma of the head and neck)