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Monoclonal Antibody
BMS-986218 + Nivolumab for Cancer
Phase 1 & 2
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
Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial will test the safety of a new drug, BMS-986218, given alone and in combination with another drug, Nivolumab, to treat advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried at least two standard treatments without success. It's open to those with specific cancers like melanoma, lung cancer, and colorectal cancer that haven't spread to the brain. Participants should be fairly active and healthy otherwise (with a performance status of 0 or 1).Check my eligibility
What is being tested?
Researchers are testing BMS-986218 alone and alongside Nivolumab to see if they're safe for treating advanced solid tumors. The study will explore different combinations of these drugs in participants who have already undergone other treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with immunotherapies such as fatigue, skin reactions, inflammation in various organs, flu-like symptoms, and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened or not responded well to at least 2 standard treatments.
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I have advanced skin cancer and have tried standard treatments, including immunotherapy.
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My colorectal cancer is not highly variable genetically and I've had standard treatments.
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My cancer is advanced and cannot be removed by surgery.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 discontinuation
Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria
Incidence of Adverse Events (AEs)
+5 moreSecondary outcome measures
Incidence of anti-drug antibody (ADA)
Maximum observed plasma concentration (Cmax)
ORR
+4 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)Experimental Treatment2 Interventions
Group II: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)Experimental Treatment2 Interventions
Group III: Part 2B: Monotherapy (BMS-986218)Experimental Treatment1 Intervention
Group IV: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)Experimental Treatment2 Interventions
Group V: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)Experimental Treatment2 Interventions
Group VI: Part 1A: Monotherapy (BMS-986218)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
BMS-986218
2022
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,320 Total Patients Enrolled
Bristol Myers SquibbStudy DirectorBristol-Myers Squibb
31 Previous Clinical Trials
32,022 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened or not responded well to at least 2 standard treatments.I do not have brain cancer or cancer that has only spread to my brain.It's been over 4 weeks since my last cancer treatment.I have advanced skin cancer and have tried standard treatments, including immunotherapy.I have NSCLC and have completed standard treatments, including immunotherapy.My colorectal cancer is not highly variable genetically and I've had standard treatments.My cancer is advanced and cannot be removed by surgery.I am fully active or can carry out light work.I have had previous cancer treatments like chemotherapy or immunotherapy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)
- Group 2: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)
- Group 3: Part 2B: Monotherapy (BMS-986218)
- Group 4: Part 1A: Monotherapy (BMS-986218)
- Group 5: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
- Group 6: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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