A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
2 other identifiers
interventional
213
3 countries
9
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 14, 2027
April 17, 2026
April 1, 2026
3 years
August 5, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of adverse events (AEs)
Up to approximately 2 years
Incidence of serious adverse events (SAEs)
Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to approximately 28 days
Incidence of AEs leading to discontinuation
Up to approximately 2 years
Incidence of AEs leading to death
Up to approximately 2 years
Secondary Outcomes (7)
Maximum observed concentration (Cmax)
Up to approximately 2 years
Time of maximum observed concentration (Tmax)
Up to approximately 2 years
Area under the concentration-time curve (AUC)
Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs)
Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Up to approximately 2 years
- +2 more secondary outcomes
Study Arms (8)
Part 1A: BMS-986484 Dose Escalation
EXPERIMENTALPart 1B: BMS-986484 + Nivolumab Dose Escalation
EXPERIMENTALPart 2A: BMS-986484 Dose Expansion
EXPERIMENTALPart 2B: BMS-986484 + Nivolumab Dose Expansion
EXPERIMENTALPart 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation
EXPERIMENTALPart 1 Co-Admin: BMS-986484 + Nivolumab
EXPERIMENTALPart 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation
EXPERIMENTALPart 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Local Institution - 0003
Tucson, Arizona, 85719, United States
Local Institution - 0007
Los Angeles, California, 90033, United States
Local Institution - 0011
Grand Rapids, Michigan, 49546, United States
Local Institution - 0004
Sioux Falls, South Dakota, 57104, United States
Local Institution - 0013
San Antonio, Texas, 78229, United States
Local Institution - 0021
Darlinghurst, New South Wales, 2010, Australia
Local Institution - 0019
Elizabeth Vale, South Australia, 5112, Australia
Local Institution - 0017
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0016
Montreal, Quebec, H2X 0A9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 9, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
October 14, 2027
Study Completion (Estimated)
October 14, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html