MedDataX Logo

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

NCT ID: NCT05543629

Last Updated: 2025-03-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2024-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

NCT06094296

NSCLC
TERMINATED PHASE2

An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

NCT03417037

Lung Cancer Non-Small Cell Lung Cancer
WITHDRAWN PHASE3

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

NCT01673867

Non-Squamous Cell Non-small Cell Lung Cancer
COMPLETED PHASE3

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

NCT01642004

Squamous Cell Non-small Cell Lung Cancer
COMPLETED PHASE3

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

NCT02754141

Malignant Solid Tumor
COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: BMS-986442 + Nivolumab

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part B1: BMS-986442 + Nivolumab

Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part B2: BMS-986442 + Nivolumab

Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part C: BMS-986442 + Nivolumab + Docetaxel

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Docetaxel

Intervention Type DRUG

Specified dose on specified days

Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Pemexetred

Intervention Type DRUG

Specified dose on specified days

Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel

Group Type EXPERIMENTAL

BMS-986442

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986442

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Docetaxel

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Pemexetred

Specified dose on specified days

Intervention Type DRUG

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Opdivo BMS-936558 Taxane / Toxotere chemotherapy Platinum chemotherapy Folate analog metabolic inhibitor Taxane chemotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Site Status

Local Institution - 0096

Costa Mesa, California, United States

Site Status

Local Institution - 0075

Orange, California, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Local Institution - 0027

Orlando, Florida, United States

Site Status

Local Institution - 0029

Fort Wayne, Indiana, United States

Site Status

Local Institution - 0022

New Orleans, Louisiana, United States

Site Status

Local Institution - 0005

Grand Rapids, Michigan, United States

Site Status

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status

Local Institution - 0003

Hackensack, New Jersey, United States

Site Status

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Site Status

Local Institution - 0019

Cincinnati, Ohio, United States

Site Status

Local Institution - 0046

Allentown, Pennsylvania, United States

Site Status

Local Institution - 0016

Houston, Texas, United States

Site Status

Local Institution - 0018

Darlinghurst, New South Wales, Australia

Site Status

Local Institution - 0001

Westmead, New South Wales, Australia

Site Status

Local Institution - 0086

Southport, Queensland, Australia

Site Status

Local Institution - 0002

Clayton, Victoria, Australia

Site Status

Local Institution - 0084

Murdoch, Western Australia, Australia

Site Status

Local Institution - 0065

Milan, Milano, Italy

Site Status

Local Institution - 0064

Candiolo, Torino, Italy

Site Status

Local Institution - 0077

Siena, Tuscany, Italy

Site Status

Local Institution - 0062

Napoli, , Italy

Site Status

Local Institution - 0067

Warsaw, Masovian Voivodeship, Poland

Site Status

Local Institution - 0073

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Local Institution - 0069

Bydgoszcz, , Poland

Site Status

Local Institution - 0080

Barcelona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0083

Madrid, Madrid, Comunidad de, Spain

Site Status

Local Institution - 0079

Madrid, Madrid, Comunidad de, Spain

Site Status

Local Institution - 0082

Málaga, , Spain

Site Status

Local Institution - 0087

Seville, , Spain

Site Status

Local Institution - 0081

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Italy Poland Spain

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

http://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-501676-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1283-1243

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA115-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BMS-986012 in Relapsed/Refractory SCLC
NCT02247349 COMPLETED PHASE1/PHASE2
S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
NCT00946712 TERMINATED PHASE3
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
NCT01721759 COMPLETED PHASE2
Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)
NCT01454102 COMPLETED PHASE1
A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
NCT03353675 COMPLETED PHASE2
Trial of BMS-986012 in Combination With Platinum and Etoposide
NCT02815592 COMPLETED PHASE1
A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
NCT06646276 RECRUITING PHASE3
A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene
NCT05469178 TERMINATED PHASE1/PHASE2
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
NCT04702880 ACTIVE_NOT_RECRUITING PHASE2
A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
NCT05005273 COMPLETED PHASE2
A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
NCT04151563 WITHDRAWN PHASE1/PHASE2
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
NCT01024062 COMPLETED PHASE2
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
NCT06561386 RECRUITING PHASE3
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer
NCT07325136 NOT_YET_RECRUITING PHASE1/PHASE2
Nivolumab in Combination With Chemotherapy, or Nivolumab in Combination With Ipilimumab, in Advanced EGFR-Mutant or ALK-Rearranged NSCLC
NCT03256136 COMPLETED PHASE2
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
NCT00461110 TERMINATED PHASE1
A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer
NCT02967133 TERMINATED PHASE2
A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC
NCT04325698 TERMINATED PHASE3
A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
NCT06946797 RECRUITING PHASE2
Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
NCT00006229 COMPLETED PHASE2/PHASE3
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
NCT05500092 RECRUITING PHASE2
Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
NCT00850577 TERMINATED PHASE2
An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
NCT02409368 COMPLETED PHASE2
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT04466917 WITHDRAWN PHASE3
A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
NCT07063745 RECRUITING PHASE2/PHASE3