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BMS-986484 + Nivolumab for Solid Tumors
San Antonio, TX
Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1
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 not have
Active, known, or suspected autoimmune disease
History of or with active interstitial lung disease or pulmonary fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to evaluate how safe and well-tolerated BMS-986484 is when given alone or in combination with nivolumab to patients with advanced solid tumors like lung cancer, colore
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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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced and cannot be removed by surgery.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an autoimmune disease.
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I have or had lung scarring or interstitial lung disease.
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I do not have any serious uncontrolled medical conditions.
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I had a blood clot not caused by a catheter in the last 6 months.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3880
Find a Location
Closest Location:Local Institution - 0013· San Antonio, TX
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,724 Previous Clinical Trials
4,128,343 Total Patients Enrolled