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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 below

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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

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

Ipilimumab

2014

Completed Phase 3

~2670

Nivolumab

2014

Completed Phase 3

~4750

BMS-986218

2022

Completed Phase 2

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,124 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities for this research endeavor still available?

"Affirmative, clinicaltrials.gov provides evidence that this medical research is presently recruiting participants. Initially posted on May 4th 2017 and last edited March 7th 2022, the team behind the trial aims to admit 390 patients across 13 different sites."

Answered by AI

How many individuals have been accepted into this clinical trial thus far?

"To be a part of this medical trial, 390 eligible candidates must take part. These people can enlist their participation at John Theurer Cancer Center in Hackensack or Dana-Farber Institute located in Boston."

Answered by AI

What illnesses is BMS-986218 typically administered to alleviate?

"BMS-986218 can be used to treat patietns with a history of anti-angiogenic therapy, malignant tumours, and unresectable melanoma."

Answered by AI

Is this research endeavor accessible in more than one geographic region within Canada?

"Patients for this medical trial are being recruited from 13 different sites. These locations range from Hackensack, Boston and Edmonton to a myriad of other cities. To streamline the process, it is recommended that one selects the nearest clinical centre when deciding on participation in order to limit travel requirements."

Answered by AI

Could you please provide a summary of the previous experiments conducted with BMS-986218?

"In 2009, BMS-986218 was initially examined at Texas Children's Hospital. Since then, 365 clinical trials have been executed while 765 continue to be conducted across the U.S., many in Hackensack, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

2017. "First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03110107.

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