MedDataX Logo

A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

NCT ID: NCT06544655

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2027-10-14

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 assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Related Clinical Trials

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

Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours

NCT05043714

Metastatic Cancer Epithelial Tumor
COMPLETED PHASE1

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

NCT02872116

Gastric Cancer Gastroesophageal Junction Cancer Esophageal Adenocarcinoma
COMPLETED PHASE3

A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

NCT02935634

Advanced Gastric Cancer
COMPLETED PHASE2

Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

NCT06846346

Metastatic Esophageal Adenocarcinoma Advanced Esophageal Adenocarcinoma Metastatic Gastric Adenocarcinoma +1 more
RECRUITING PHASE2

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)

NCT02494583

Gastric Adenocarcinoma
COMPLETED PHASE3

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

Study Design

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

Allocation Method

NON_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 1A: BMS-986484 Dose Escalation

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Part 1B: BMS-986484 + Nivolumab Dose Escalation

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A: BMS-986484 Dose Expansion

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Part 2B: BMS-986484 + Nivolumab Dose Expansion

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Capecitabine

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Calcium folinate

Intervention Type DRUG

Specified dose on specified days

Part 1 Co-Admin: BMS-986484 + Nivolumab

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion

Group Type EXPERIMENTAL

BMS-986484

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

Capecitabine

Intervention Type DRUG

Specified dose on specified days

Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Calcium folinate

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-986484

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Oxaliplatin

Specified dose on specified days

Intervention Type DRUG

Capecitabine

Specified dose on specified days

Intervention Type DRUG

Fluorouracil

Specified dose on specified days

Intervention Type DRUG

Calcium folinate

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

Eligibility Criteria

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

Inclusion Criteria

* Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
* Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
* Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Exclusion Criteria

* History of or with active interstitial lung disease or pulmonary fibrosis.
* Active, known, or suspected autoimmune disease.
* Serious uncontrolled medical disorders.
* New onset, non-catheter-associated venous thromboembolism within the past 6 months.
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.

University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

START Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status RECRUITING

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Local Institution - 0023

Chuo-ku, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Local Institution - 0022

Kashiwa, , Japan

Site Status NOT_YET_RECRUITING

Countries

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

United States Australia Canada Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

[email protected]
855-907-3286

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aaron Scott, Site 0003

Role: primary

520-626-2430

Anthony El-Khoueiry, Site 0007

Role: primary

323-865-3967

Manish Sharma, Site 0011

Role: primary

616-600-3810

Steven Powell, Site 0004

Role: primary

605-328-8000

David Sommerhalder, Site 0013

Role: primary

210-580-9500

Jia Liu, Site 0021

Role: primary

+61 02 9355 5600

Christopher Hocking, Site 0019

Role: primary

0871177265

Albiruni Abdul Razak, Site 0017

Role: primary

6479709845

Rahima Jamal, Site 0016

Role: primary

51489080008444

Site 0023

Role: primary

Site 0022

Role: primary

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/clinical-trials/NCT06544655.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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

EU 2024-513696-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA233-0000

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
NCT03776487 ACTIVE_NOT_RECRUITING PHASE2
Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma
NCT06093425 NOT_YET_RECRUITING PHASE3
Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)
NCT04021108 ACTIVE_NOT_RECRUITING PHASE2
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
NCT06256328 ACTIVE_NOT_RECRUITING PHASE2
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
NCT06551142 RECRUITING PHASE1
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer
NCT05165264 ACTIVE_NOT_RECRUITING
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
NCT00548548 COMPLETED PHASE3
A Single-arm, Single-center Phase II Clinical Study on the Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Combined With Fruquintinib Capsules in the Second-line Treatment of Patients With Advanced Gastric Cancer
NCT06706895 NOT_YET_RECRUITING PHASE2
A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
NCT06415669 RECRUITING PHASE2
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
NCT05111626 ACTIVE_NOT_RECRUITING PHASE3
Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma
NCT06440811 COMPLETED
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06341335 RECRUITING PHASE3
A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer
NCT06776770 RECRUITING PHASE1/PHASE2
Efficacy and Safety of Anlotinib Hydrochloride Combined With Nivolumab in the Treatment of Gastric and Esophageal Cancer
NCT04503967 UNKNOWN PHASE2
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
NCT06203600 RECRUITING PHASE2/PHASE3
Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC
NCT06684158 NOT_YET_RECRUITING PHASE2
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
NCT06349967 NOT_YET_RECRUITING PHASE2
A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer
NCT05334719 ACTIVE_NOT_RECRUITING
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
NCT07070466 NOT_YET_RECRUITING PHASE2
Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma
NCT03995017 UNKNOWN PHASE1/PHASE2
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
NCT03704077 WITHDRAWN PHASE2
Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma
NCT05268510 COMPLETED PHASE2
A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer.
NCT06339216 NOT_YET_RECRUITING PHASE2
Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors
NCT04079712 ACTIVE_NOT_RECRUITING PHASE2
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
NCT02864381 COMPLETED PHASE2