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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
  • - Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06544655
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part 1A: BMS-986484 Dose Escalation

Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation

Experimental: Part 2A: BMS-986484 Dose Expansion

Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion

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

Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab

Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation

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

Interventions

Drug: - BMS-986484

Specified dose on specified days

Biological: - Nivolumab

Specified dose on specified days

Drug: - Oxaliplatin

Specified dose on specified days

Drug: - Capecitabine

Specified dose on specified days

Drug: - Fluorouracil

Specified dose on specified days

Drug: - Calcium folinate

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona Cancer Center, Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

University of Arizona Cancer Center

Tucson 5318313, Arizona 5551752, 85719

Site Contact

Aaron Scott, Site 0003

[email protected]

520-626-2430

USC/Norris Comprehensive Cancer Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

USC/Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

Site Contact

Anthony El-Khoueiry, Site 0007

[email protected]

323-865-3967

START Midwest, Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

START Midwest

Grand Rapids 4994358, Michigan 5001836, 49546

Site Contact

Manish Sharma, Site 0011

[email protected]

616-600-3810

Sanford Cancer Center, Sioux Falls 5231851, South Dakota 5769223

Status

Recruiting

Address

Sanford Cancer Center

Sioux Falls 5231851, South Dakota 5769223, 57104

Site Contact

Steven Powell, Site 0004

[email protected]

605-328-8000

NEXT Oncology, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

NEXT Oncology

San Antonio 4726206, Texas 4736286, 78229

Site Contact

David Sommerhalder, Site 0013

[email protected]

210-580-9500

International Sites

St Vincent's Hospital, Darlinghurst 2169378, New South Wales 2155400, Australia

Status

Recruiting

Address

St Vincent's Hospital

Darlinghurst 2169378, New South Wales 2155400, 2010

Site Contact

Jia Liu, Site 0021

[email protected]

+61 02 9355 5600

Lyell McEwin Hospital, Elizabeth Vale 9973185, South Australia 2061327, Australia

Status

Recruiting

Address

Lyell McEwin Hospital

Elizabeth Vale 9973185, South Australia 2061327, 5112

Site Contact

Christopher Hocking, Site 0019

[email protected]

0871177265

Princess Margaret Cancer Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto 6167865, Ontario 6093943, M5G 2M9

Site Contact

Albiruni Abdul Razak, Site 0017

[email protected]

6479709845

Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

Centre Hospitalier de l'Université de Montréal

Montreal 6077243, Quebec 6115047, H2X 0A9

Site Contact

Rahima Jamal, Site 0016

[email protected]

51489080008444

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