← Back to Search

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)
Must not have
Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

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 below
Select...
My cancer has worsened or not responded well to at least 2 standard treatments.
Select...
I have advanced skin cancer and have tried standard treatments, including immunotherapy.
Select...
My colorectal cancer is not highly variable genetically and I've had standard treatments.
Select...
My cancer is advanced and cannot be removed by surgery.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have brain cancer or cancer that has only spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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 discontinuation
Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria
Incidence of Adverse Events (AEs)
+5 more
Secondary outcome measures
Incidence of anti-drug antibody (ADA)
Maximum observed plasma concentration (Cmax)
ORR
+4 more

Trial 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
~4740
Ipilimumab
2014
Completed Phase 3
~2610
BMS-986218
2022
Completed Phase 2
~10

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common cancer treatments, particularly immune checkpoint inhibitors like Nivolumab, work by targeting proteins such as PD-1 that regulate the immune system's ability to attack cancer cells. By inhibiting these proteins, these treatments enhance the immune system's response against cancer cells. This mechanism is significant for cancer patients as it leverages their own immune system to combat the disease, potentially improving outcomes and reducing side effects compared to traditional therapies like chemotherapy.
Toward precision medicine in inflammatory breast cancer.Immunotherapeutic Targets and Therapy for Renal Cell Carcinoma.Understanding Immune Checkpoint Inhibitors for Effective Patient Care.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,237 Total Patients Enrolled
Bristol Myers SquibbStudy DirectorBristol-Myers Squibb
31 Previous Clinical Trials
32,022 Total Patients Enrolled

Media Library

BMS-986218 (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03110107 — Phase 1 & 2
BMS-986218 (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03110107 — Phase 1 & 2
Cancer Research Study Groups: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab), Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab), Part 2B: Monotherapy (BMS-986218), Part 1A: Monotherapy (BMS-986218), Part 2A: Monotherapy (BMS-986218 OR Ipilimumab), Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
Cancer Clinical Trial 2023: BMS-986218 Highlights & Side Effects. Trial Name: NCT03110107 — Phase 1 & 2
~63 spots leftby Jul 2025