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

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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumors; Non-small Cell Lung Cancer
• Intervention / Treatment: Biological: Nivolumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Docetaxel; Biological: BMS-986442; Drug: Pemexetred

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Local Institution - 0018
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0001
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Local Institution - 0086
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0002
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Local Institution - 0084
• Italy
  • Napoli, Italy, 80131
    • Local Institution - 0062
  • Milano
    • Milan, Milano, Italy, 20162
      • Local Institution - 0065
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Local Institution - 0064
  • Toscana
    • Siena, Toscana, Italy, 53100
      • Local Institution - 0077
• Poland
  • Bydgoszcz, Poland, 85796
    • Local Institution - 0069
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Local Institution - 0067
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-952
      • Local Institution - 0073
• Spain
  • Málaga, Spain, 29011
    • Local Institution - 0082
  • Sevilla, Spain, 41013
    • Local Institution - 0087
  • València, Spain, 46026
    • Local Institution - 0081
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Local Institution - 0080
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28009
      • Local Institution - 0083
    • Madrid, Madrid, Comunidad De, Spain, 28041
      • Local Institution - 0079
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona - Phoenix
  • California
    • Costa Mesa, California, United States, 92627
      • Local Institution - 0096
    • Orange, California, United States, 92868-3201
      • Local Institution - 0075
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
    • Orlando, Florida, United States, 32804
      • Local Institution - 0027
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Local Institution - 0029
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Local Institution - 0022
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Local Institution - 0005
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester, Minnesota
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0003
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Local Institution - 0019
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Local Institution - 0046
  • Texas
    • Houston, Texas, United States, 77030
      • Local Institution - 0016

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: BMS-986442 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986442; Specified dose on specified days
Experimental: Part B1: BMS-986442 + Nivolumab; Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986442; Specified dose on specified days
Experimental: Part B2: BMS-986442 + Nivolumab; Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: BMS-986442; Specified dose on specified days
Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Docetaxel; Specified dose on specified days; Other Names: Taxane / Toxotere chemotherapy; Biological: BMS-986442; Specified dose on specified days
Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Carboplatin; Specified dose on specified days; Other Names: Platinum chemotherapy; Biological: BMS-986442; Specified dose on specified days; Drug: Pemexetred; Specified dose on specified days; Other Names: Folate analog metabolic inhibitor
Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: Carboplatin; Specified dose on specified days; Other Names: Platinum chemotherapy; Drug: Paclitaxel; Specified dose on specified days; Other Names: Taxane chemotherapy; Biological: BMS-986442; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).	From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Serious Adverse Events	A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death.; Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).; Requires inpatient hospitalization or causes prolongation of existing hospitalization	From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Adverse Events Leading to Discontinuation	Number of Participants with adverse events leading to discontinuation	From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Dose Limiting Toxicities	DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: Any death that is not clearly due to the underlying disease or extraneous causes; Any Grade ≥ 3 non-hematological toxicity; Any Grade myocarditis; Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome; Grade 4 neutropenia of > 7 days duration; Grade 4 thrombocytopenia.; Grade 3 thrombocytopenia with clinically significant bleeding.; Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.	From Cycle 1 day 1 to day 28 (28 Days)
Number of Participants Who Died	Number of Participants who died	From first dose to 100 days post last dose (Approximately 6 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMax	Maximum observed serum concentration	On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Tmax	Time of maximum observed serum concentration	On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
AUC (Tau)	Area under the serum concentration-time curve in 1 dosing interval	On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)	Number of participants with BMS-986442 Anti Drug Antibody (ADA)	From first dose to 100 days post last dose (Approximately 6 Months)
Objective Response Rate (ORR) Per Recist v1.1 by Investigator	ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).	From first dose to 100 days post last dose (Approximately 6 Months)
Disease Control Rate (DCR) Per Recist v1.1 by Investigator	Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD > 6 months), based on investigator assessments divided by the number of all treated participants.	From first dose to 100 days post last dose (Approximately 6 Months)

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

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Nivolumab; Chemotherapy; BMS-986442
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Docetaxel; Nivolumab; Carboplatin; Paclitaxel; Taxane
• Other Study ID Numbers: CA115-001; 2022-501676-26 (EudraCT Number); U1111-1283-1243 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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