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Part 1A: BMS-986484 Dose Escalation for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

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).

Who is the study for?
This trial is for people with advanced solid tumors, including lung, colorectal, pancreatic, stomach/esophageal, and head/neck cancers. Participants must have a tumor that hasn't responded to standard treatments or has come back.
What is being tested?
The study tests BMS-986484 alone and combined with Nivolumab in patients with certain types of cancer. It aims to find out how safe these drugs are and how well they work together.
What are the potential side effects?
Possible side effects include immune-related reactions affecting the lungs, liver, intestines, hormone glands; skin rash; infusion-related reactions; fatigue; and potential worsening of pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs leading to death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
+2 more
Secondary outcome measures
Area under the concentration-time curve (AUC)
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2B: BMS-986484 + Nivolumab Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2A: BMS-986484 Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1B: BMS-986484 + Nivolumab Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1A: BMS-986484 Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,666 Previous Clinical Trials
4,132,993 Total Patients Enrolled
~89 spots leftby Oct 2027
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