A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05543629
• Other study ID #: CA115-001
• Secondary ID: 2022-501676-26U1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 4, 2022
• Est. completion date: November 1, 2026

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion Criteria:

• Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
• Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
• Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Biological:
• BMS-986442
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Drug:
• Docetaxel
Specified dose on specified days
• Carboplatin
Specified dose on specified days
• Pemexetred
Specified dose on specified days
• Paclitaxel
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0002	Clayton	Victoria
Australia	Local Institution - 0018	Darlinghurst	New South Wales
Australia	Local Institution - 0084	Murdoch	Western Australia
Australia	Local Institution - 0086	Southport	Queensland
Australia	Local Institution - 0001	Westmead	New South Wales
Italy	Istituto di Candiolo	Candiolo	Torino
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milan	Milano
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli
Italy	Azienda Ospedaliero Universitaria Senese	Siena	Toscana
Poland	Local Institution - 0069	Bydgoszcz
Poland	Local Institution - 0073	Gdansk	Pomorskie
Poland	Local Institution - 0068	Lódz	Lódzkie
Poland	Local Institution - 0067	Warszawa	Mazowieckie
Spain	Local Institution - 0080	Barcelona	Barcelona [Barcelona]
Spain	Local Institution - 0079	Madrid	Madrid, Comunidad De
Spain	Local Institution - 0083	Madrid	Madrid, Comunidad De
Spain	Local Institution - 0082	Málaga
Spain	Local Institution - 0087	Sevilla
Spain	Local Institution - 0081	València
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Miami Sylvester Comprehensive Cancer Center - Aventura	Aventura	Florida
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of California, Irvine (UCI) Health Cancer Center - Newport/Costa Mesa	Costa Mesa	California
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	START Midwest	Grand Rapids	Michigan
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of California, Irvine (UCI) Health - UC Irvine Medical Center	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona
United States	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 119 Weeks
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 119 Weeks
Primary	Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria		Up to 119 Weeks
Primary	Incidence of AEs leading to discontinuation		Up to 119 Weeks
Primary	Incidence of AEs leading to death		Up to 119 Weeks
Secondary	Maximum observed plasma concentration (Cmax)		Up to 119 Weeks
Secondary	Time of maximum observed concentration (Tmax)		Up to 119 Weeks
Secondary	Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])		Up to 119 Weeks
Secondary	Incidence of Anti-drug Antibodies (ADAs) to BMS-986442		Up to 119 Weeks
Secondary	Objective Response Rate (ORR)		At 6 months and 12 months
Secondary	Duration of Response (DOR)		At 6 months and 12 months
Secondary	Disease Control Rate (DCR)		At 6 months and 12 months
Secondary	Progression-free Survival Rate (PFSR)		At 6 months and 12 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls