- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2024-10-10
2027-10-14
2027-10-14
213
NCT06544655
Bristol-Myers Squibb
Bristol-Myers Squibb
INTERVENTIONAL
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
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).
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-08-05 | N/A | 2025-08-06 |
2024-08-05 | N/A | 2025-08-11 |
2024-08-09 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1A: BMS-986484 Dose Escalation | DRUG: BMS-986484
|
| EXPERIMENTAL: Part 1B: BMS-986484 + Nivolumab Dose Escalation | DRUG: BMS-986484
BIOLOGICAL: Nivolumab
|
| EXPERIMENTAL: Part 2A: BMS-986484 Dose Expansion | |
| EXPERIMENTAL: Part 2B: BMS-986484 + Nivolumab Dose Expansion | BIOLOGICAL: Nivolumab
|
| EXPERIMENTAL: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation | DRUG: BMS-986484
BIOLOGICAL: Nivolumab
DRUG: Oxaliplatin
DRUG: Capecitabine
DRUG: Fluorouracil
DRUG: Calcium folinate
|
| EXPERIMENTAL: Part 1 Co-Admin: BMS-986484 + Nivolumab | DRUG: BMS-986484
BIOLOGICAL: Nivolumab
|
| EXPERIMENTAL: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation | DRUG: BMS-986484
|
| EXPERIMENTAL: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion | DRUG: Oxaliplatin
DRUG: Capecitabine
DRUG: Fluorouracil
DRUG: Calcium folinate
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 2 years | |
| Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: BMS Study Connect Contact Center www.BMSStudyConnect.com Phone Number: 855-907-3286 Email: Clinical.Trials@bms.com |
Study Contact Backup Name: First line of the email MUST contain NCT # and Site #. Phone Number: Email: |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
