Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Phase 1
Terminated
- Conditions
- Advanced Solid Tumor
- Interventions
- Registration Number
- NCT04349267
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986315 + cetuximab cetuximab - BMS-986315 BMS-986315 - BMS-986315 + nivolumab BMS-986315 - BMS-986315 + nivolumab nivolumab - BMS-986315 + cetuximab BMS-986315 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria Up to 119 weeks Incidence of serious adverse events (SAEs) Up to 119 weeks Number of deaths Up to 119 weeks Incidence of adverse events (AEs) leading to discontinuation Up to 119 weeks Incidence of adverse events (AEs) Up to 119 weeks
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) 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 Objective Response Rate (ORR) Up to 12 months 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 Duration of Response (DOR) Up to 12 months Maximum observed serum concentration (Cmax) of BMS-986315 Up to 16 weeks Time of maximum observed serum concentration (Tmax) of BMS-986315 Up to 16 weeks Incidence of anti-drug antibodies to BMS-986315 Up to 119 weeks Progression-Free Survival Rate (PFSR) Up to 12 months 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 in 1 dosing interval [AUC(TAU)] of BMS-986315 Up to 16 weeks Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 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 with nivolumab Up to 16 weeks Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab Up to 16 weeks Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab Up to 16 weeks Trough observed serum concentrations (Ctrough) of BMS-986315 Up to 119 weeks Incidence of anti-drug antibodies to BMS-986315 with cetuximab Up to 119 weeks Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab Up to 16 weeks Incidence of anti-drug antibodies to BMS-986315 with nivolumab Up to 119 weeks
Trial Locations
- Locations (8)
Local Institution - 0001
🇺🇸Germantown, Tennessee, United States
Local Institution - 0028
🇺🇸Sioux Falls, South Dakota, United States
Local Institution - 0013
🇨🇦Ottawa, Canada
Local Institution - 0011
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0005
🇨🇦Montreal, Quebec, Canada
Local Institution - 0004
🇨🇦Toronto, Ontario, Canada
Local Institution - 0014
🇨🇦Edmonton, Alberta, Canada
Local Institution
🇲🇽Mexico city, Distrito Federal, Mexico