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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05543629
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Non-small Cell Lung Cancer Biological: BMS-986442 Biological: Nivolumab Drug: Docetaxel Drug: Carboplatin Drug: Pemexetred Drug: Paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: BMS-986442 + Nivolumab Biological: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part B1: BMS-986442 + Nivolumab
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
 Biological: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
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: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel Biological: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Docetaxel
Specified dose on specified days
Other Name: Taxane / Toxotere chemotherapy
Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed Biological: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Carboplatin
Specified dose on specified days
Other Name: Platinum chemotherapy

Drug: Pemexetred
Specified dose on specified days
Other Name: Folate analog metabolic inhibitor
Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel Biological: BMS-986442
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Carboplatin
Specified dose on specified days
Other Name: Platinum chemotherapy

Drug: Paclitaxel
Specified dose on specified days
Other Name: Taxane chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 119 Weeks ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 119 Weeks ]
  3. Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [ Time Frame: Up to 119 Weeks ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 119 Weeks ]
  5. Incidence of AEs leading to death [ Time Frame: Up to 119 Weeks ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 119 Weeks ]
  2. Time of maximum observed concentration (Tmax) [ Time Frame: Up to 119 Weeks ]
  3. Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) [ Time Frame: Up to 119 Weeks ]
  4. Incidence of Anti-drug Antibodies (ADAs) to BMS-986442 [ Time Frame: Up to 119 Weeks ]
  5. Objective Response Rate (ORR) [ Time Frame: At 6 months and 12 months ]
  6. Duration of Response (DOR) [ Time Frame: At 6 months and 12 months ]
  7. Disease Control Rate (DCR) [ Time Frame: At 6 months and 12 months ]
  8. Progression-free Survival Rate (PFSR) [ Time Frame: At 6 months and 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543629


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05543629    
Other Study ID Numbers: CA115-001
2022-501676-26 ( EudraCT Number )
U1111-1283-1243 ( Registry Identifier: WHO )
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986442
Nivolumab
Chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Docetaxel
 Carboplatin
Nivolumab
Taxane
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors