A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

NCT04943900 | Completed Phase 1 FDA Drug

• 1 other identifier: CA102-003
• Study Type: interventional
• Target: 67
• Locations: 7 countries
• Sites: 19

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

BMS-986416; Nivolumab; Opdivo; Non-small cell lung cancer (NSCLC); Urothelial carcinoma (UC); Squamous cell carcinoma of the head and neck (SCCHN); Hepatocellular carcinoma (HCC); Microsatellite-stable colorectal carcinoma (MSS CRC); Pancreatic ductal adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (6)

• Incidence of Adverse Events (AEs)

  Up to 100 days after the last treatment of study intervention(s)

• Incidence of Serious Adverse Events (SAEs)

  Up to 100 days after the last treatment of study intervention(s)

• Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

  Up to 100 days after the last treatment of study intervention(s)

• Incidence of AEs leading to discontinuation

  Up to 100 days after the last treatment of study intervention(s)

• Incidence of AEs leading to death

  Up to 100 days after the last treatment of study intervention(s)

• Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)

  Up to 100 days after the last treatment of study intervention(s)

Secondary Outcomes (6)

• Maximum observed serum concentration (Cmax) of BMS-986416

  Up to 100 days after the last treatment of study intervention(s)

• Time of maximum observed serum concentration (Tmax) of BMS-986416

  Up to 100 days after the last treatment of study intervention(s)

• Trough observed serum concentration (Ctrough) of BMS-986416

  Up to 100 days after the last treatment of study intervention(s)

• Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment

  Up to 2 years

• Duration of Response (DOR) using RECIST 1.1 per Investigator assessment

  Up to 2 years

Study Arms (2)

Part 1A: Monotherapy (BMS-986416)

EXPERIMENTAL

Drug: BMS-986416

Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

EXPERIMENTAL

Drug: BMS-986416; Drug: Nivolumab

Interventions

BMS-986416 DRUG

Specified dose on specified days

Part 1A: Monotherapy (BMS-986416); Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

Nivolumab DRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

Eligibility Criteria

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

You may qualify if:

• Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
• Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
• Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
• Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
• Disease amenable to serial biopsy

You may not qualify if:

• Uncontrolled or significant cardiovascular disease
• Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
• Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (19)

Local Institution - 0006

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0005

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0002

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0013

Cleveland, Ohio, 44106-1716, United States

Location

Local Institution - 0003

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0004

Houston, Texas, 77030, United States

Location

Local Institution - 0021

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0027

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Local Institution - 0022

CABA, Buenos Aires F.D., C1430EGF, Argentina

Location

Local Institution - 0043

Edegem, Antwerpen, 2650, Belgium

Location

Local Institution - 0016

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Local Institution - 0009

Edmonton, Alberta, T6X 1E8, Canada

Location

Local Institution - 0008

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0001

Montreal, Quebec, H2X 3H8, Canada

Location

Local Institution - 0025

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0026

Santiago, Santiago Metropolitan, 7620002, Chile

Location

Local Institution - 0024

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0010

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 0020

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Hepatocellular

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 29, 2021
• Study Start: August 9, 2021
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (6); JP (1); AR (3); NL (1); CA (3); BE (2); CL (3)