Description:
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab
or cetuximab in participants with advanced solid tumors.
Title
- Brief Title: Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
- Official Title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA047-004
- NCT ID:
NCT04349267
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986315 | | BMS-986315 |
| nivolumab | | BMS-986315 + nivolumab |
| cetuximab | | BMS-986315 + cetuximab |
Purpose
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab
or cetuximab in participants with advanced solid tumors.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BMS-986315 | Experimental | | |
| BMS-986315 + nivolumab | Experimental | | |
| BMS-986315 + cetuximab | Experimental | | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of adverse events (AEs) |
| Time Frame: | Up to 119 weeks |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-Free Survival Rate (PFSR) |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) of BMS-986315 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) of BMS-986315 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab |
| Time Frame: | Up to 16 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentrations (Ctrough) of BMS-986315 |
| Time Frame: | Up to 119 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibodies to BMS-986315 |
| Time Frame: | Up to 119 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibodies to BMS-986315 with nivolumab |
| Time Frame: | Up to 119 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibodies to BMS-986315 with cetuximab |
| Time Frame: | Up to 119 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- NSCLC (Non-small cell lung cancer)
- RCC (Renal cell carcinoma)
- SCCHN (Squamous cell carcinoma of the head and neck)
Last Updated
August 20, 2021
