What side effects are associated with this type of intervention?

Checkpoint inhibitors, such as Nivolumab, are associated with immune-related adverse events including gastrointestinal toxicity (e.g., diarrhea, colitis), skin reactions (e.g., rash, pruritus), and endocrine disorders (e.g., thyroid dysfunction). Combination therapies, such as Nivolumab plus Ipilimumab, tend to have higher rates of severe adverse events, including gastrointestinal toxicity and the need for treatment discontinuation. Chemotherapy, often used in combination with checkpoint inhibitors, can cause side effects like nausea, fatigue, and increased risk of infection. Management of these side effects typically involves dose adjustments, supportive care, and close monitoring.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has received FDA approval for treating several cancers, including metastatic melanoma, non-small cell lung cancer (NSCLC), and advanced gastric cancer. Pembrolizumab, another PD-1 inhibitor, is similarly approved for these indications. Combination therapies, such as Nivolumab with Ipilimumab (a CTLA-4 inhibitor), have also been approved for advanced melanoma, demonstrating the FDA's endorsement of immune checkpoint inhibitors in cancer therapy.

What other types of research exist?

Promising alternatives to BMS-986218 and Nivolumab for cancer patients include Atezolizumab (a PD-L1 inhibitor effective in metastatic triple-negative breast cancer), Pembrolizumab (another PD-1 inhibitor with broad applications across various cancers), and combination therapies such as Nivolumab plus Ipilimumab (CTLA-4 inhibitor) which have shown improved outcomes in advanced melanoma and non-small cell lung cancer. Additionally, emerging therapies like Relatlimab (LAG-3 inhibitor) combined with Nivolumab are also showing promise in clinical trials.

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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)

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

No Placebo-Only Group

Summary

This trial is testing whether a new drug, BMS-986218, alone or with Nivolumab, is safe for patients with advanced solid tumors. These drugs help the immune system fight cancer. Nivolumab is a treatment that has been used for various cancers, including melanoma, lung cancer, and renal cell carcinoma.

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).

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain cancer or cancer that has only spread to my brain.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median Duration of Response (mDOR)

Objective Response Rate (ORR)

Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary study objectives

ORR

PFSR by RECIST v1.1

mDOR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

BMS-986218

2022

Completed Phase 2

~10

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3070

0 / 6Eligibility criteria met

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.