MedDataX Logo

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

NCT ID: NCT03994601

Last Updated: 2026-01-20

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2024-08-31

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 determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Related Clinical Trials

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

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

NCT03369223

Advanced Cancer
COMPLETED PHASE1/PHASE2

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

NCT03956680

Advanced Solid Cancers
COMPLETED PHASE1

An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT03661632

Advanced Cancer
COMPLETED PHASE1

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

NCT04943900

Advanced Solid Tumors
COMPLETED PHASE1

A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

NCT06697197

Advanced Solid Tumors
RECRUITING 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 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

PARALLEL

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.

Arm A: BMS-986288 Monotherapy

Group Type EXPERIMENTAL

BMS-986288

Intervention Type DRUG

Specified dose on specified days

Arm B: BMS-986288 in combination with Nivolumab

Group Type EXPERIMENTAL

BMS-986288

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Group Type EXPERIMENTAL

BMS-986288

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Regorafenib

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-986288

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Regorafenib

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

Eligibility Criteria

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

Inclusion Criteria

* Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion Criteria

* Active, known or suspected autoimmune disease
* Active malignancy requiring concurrent intervention
* Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
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.

Local Institution - 0075

Costa Mesa, California, United States

Site Status

Local Institution - 0050

Orange, California, United States

Site Status

Local Institution - 0005

Aurora, Colorado, United States

Site Status

Local Institution - 0002

Baltimore, Maryland, United States

Site Status

Local Institution - 0004

St Louis, Missouri, United States

Site Status

Local Institution - 0001

Hackensack, New Jersey, United States

Site Status

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0074

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0014

Córdoba, Córdoba Province, Argentina

Site Status

Local Institution - 0013

Río Cuarto, Córdoba Province, Argentina

Site Status

Local Institution - 0008

ABB, Distrito Federal, Argentina

Site Status

Local Institution - 0012

CABA, Distrito Federal, Argentina

Site Status

Local Institution - 0017

Buenos Aires, , Argentina

Site Status

Local Institution - 0016

Buenos Aires, , Argentina

Site Status

Local Institution - 0006

Toronto, Ontario, Canada

Site Status

Local Institution - 0042

Montreal, Quebec, Canada

Site Status

Local Institution - 0046

Montreal, Quebec, Canada

Site Status

Local Institution - 0010

Viña del Mar, Región de Valparaíso, Chile

Site Status

Local Institution - 0036

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0019

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0035

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0009

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0034

Bordeaux, Gironde, France

Site Status

Local Institution - 0022

Saint-Herblain, Loire-Atlantique, France

Site Status

Local Institution - 0018

Bron, , France

Site Status

Local Institution - 0026

Marseille, , France

Site Status

Local Institution - 0015

Paris, , France

Site Status

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, , France

Site Status

Local Institution - 0040

Milan, Lombardy, Italy

Site Status

Local Institution - 0038

Padua, Veneto, Italy

Site Status

Local Institution - 0028

Ancona, , Italy

Site Status

Local Institution - 0033

Catanzaro, , Italy

Site Status

Local Institution - 0031

Milan, , Italy

Site Status

Local Institution - 0039

Roma, , Italy

Site Status

Local Institution - 0056

Barcelona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0054

Barcelona, Catalunya [Cataluña], Spain

Site Status

Local Institution - 0023

Madrid, , Spain

Site Status

Local Institution - 0024

Majadahonda, , Spain

Site Status

Local Institution - 0055

Seville, , Spain

Site Status

Local Institution - 0025

Valencia, , Spain

Site Status

Countries

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

United States Argentina Canada Chile France Italy 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.bmsclinicaltrials.com/us/en/home

BMS Clinical Trial Patient Recruiting

Other Identifiers

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

2021-004284-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA043-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
NCT05888831 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
NCT05298592 COMPLETED PHASE1
Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
NCT02966548 COMPLETED PHASE1
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
NCT03110107 TERMINATED PHASE1/PHASE2
A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
NCT02913313 COMPLETED PHASE1/PHASE2
Study of BMS-986158 in Subjects With Select Advanced Cancers
NCT02419417 COMPLETED PHASE1/PHASE2
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
NCT03400332 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
NCT05625412 COMPLETED PHASE1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer
NCT03351231 TERMINATED PHASE1/PHASE2
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
NCT06764771 ACTIVE_NOT_RECRUITING PHASE1
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
NCT04895709 RECRUITING PHASE1/PHASE2
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
NCT06618287 RECRUITING PHASE1/PHASE2
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
NCT04349267 COMPLETED PHASE1/PHASE2
Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy
NCT05065866 COMPLETED PHASE1
Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors
NCT01653470 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
NCT07223047 RECRUITING PHASE1/PHASE2
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
NCT06997029 RECRUITING PHASE1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
NCT03363776 TERMINATED PHASE1/PHASE2
BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers
NCT04021043 COMPLETED PHASE1/PHASE2
COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.
NCT04570839 COMPLETED PHASE1/PHASE2
A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
NCT03203876 COMPLETED PHASE1
Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer
NCT02453620 ACTIVE_NOT_RECRUITING PHASE1
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
NCT06589596 RECRUITING PHASE1
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
NCT03650894 ACTIVE_NOT_RECRUITING PHASE2
An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors
NCT03745807 COMPLETED PHASE1