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

NCT04349267 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CA047-004
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 8

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.

Conditions

Advanced Solid Tumor

Keywords

NSCLC (Non-small cell lung cancer); RCC (Renal cell carcinoma); SCCHN (Squamous cell carcinoma of the head and neck)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events and Deaths

  An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

  From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.

  From first dose (Day 1) untill Day 28

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

• Duration of Response (DoR)

  From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

• Progression Free Survival (PFS) Rate

  At 6 months

• Maximum Plasma Concentration (Cmax) of BMS-986315

  Cycle 1 Day 1

• Time to Maximum Plasma Concentration (Tmax) of BMS-986315

  Cycle 1 Day 1

Study Arms (3)

BMS-986315

EXPERIMENTAL

Biological: BMS-986315

BMS-986315 + nivolumab

EXPERIMENTAL

Biological: BMS-986315; Biological: nivolumab

BMS-986315 + cetuximab

EXPERIMENTAL

Biological: BMS-986315; Biological: cetuximab

Interventions

BMS-986315 BIOLOGICAL

Specified dose on specified days

BMS-986315; BMS-986315 + cetuximab; BMS-986315 + nivolumab

nivolumab BIOLOGICAL

Specified dose on specified days

BMS-986315 + nivolumab

cetuximab BIOLOGICAL

Specified dose on specified days

BMS-986315 + cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Local Institution - 0028

Sioux Falls, South Dakota, 57104, United States

Location

Local Institution - 0001

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0014

Edmonton, Alberta, T6X 1E8, Canada

Location

Local Institution - 0011

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0004

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0005

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0013

Ottawa, K1H 8L6, Canada

Location

Local Institution

Mexico City, Mexico City, 06100, Mexico

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Interventions

Nivolumab; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 16, 2020
• Study Start: July 14, 2020
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Locations

US (2); CA (5); ME (1)