Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

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

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Biological: nivolumab; Biological: BMS-986315; Biological: cetuximab

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Canada
  • Ottawa, Canada, K1H 8L6
    • Local Institution - 0013
  • Alberta
    • Edmonton, Alberta, Canada, T6X 1E8
      • Local Institution - 0014
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Local Institution - 0011
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0004
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Local Institution - 0005
• Mexico
  • Distrito Federal
    • Mexico city, Distrito Federal, Mexico, 06100
      • Local Institution
• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Local Institution - 0028
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986315	Biological: BMS-986315; Specified dose on specified days
Experimental: BMS-986315 + nivolumab	Biological: nivolumab; Specified dose on specified days; Biological: BMS-986315; Specified dose on specified days
Experimental: BMS-986315 + cetuximab	Biological: BMS-986315; Specified dose on specified days; Biological: cetuximab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC (Non-small cell lung cancer); RCC (Renal cell carcinoma); SCCHN (Squamous cell carcinoma of the head and neck)
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Cetuximab
• Other Study ID Numbers: CA047-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No