What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors like Nivolumab (a PD-1 inhibitor) include fatigue, rash, pruritus, diarrhea, and pneumonitis. Severe adverse events can include immune-related reactions such as colitis, hepatitis, endocrinopathies, and pneumonitis. When combined with other therapies, such as chemotherapy, the incidence of severe side effects like anemia, nausea, and generalized edema can increase. Management of these side effects often involves dose adjustments, supportive care, and sometimes immunosuppressive treatments.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for cancer treatment, particularly those targeting PD-1 and PD-L1 pathways. Nivolumab, a PD-1 inhibitor, is approved for various cancers, including metastatic non-small cell lung cancer (NSCLC) and advanced melanoma. Pembrolizumab, another PD-1 inhibitor, is approved for similar indications and more, including as adjuvant therapy for melanoma. Additionally, the combination of Nivolumab and Ipilimumab, a CTLA-4 inhibitor, has been approved for advanced melanoma, showing improved outcomes compared to monotherapy. These approvals highlight the effectiveness of targeting immune checkpoints in cancer therapy.

What other types of research exist?

Promising novel alternatives to BMS-986288 and Nivolumab for cancer treatment in 2024 include LY3321367 (TIM-3 inhibition) alone or in combination with LY300054 (anti-PD-L1 antibody), and combination therapies such as ipilimumab (CTLA-4 inhibition) with nivolumab. Additionally, pembrolizumab (PD-1 inhibition) combined with chemotherapy or other agents like VEGF pathway blockers, and emerging therapies like dostarlimab for dMMR tumors, are also promising options.

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Immunotherapy

BMS-986288 + 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

Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy

Eastern Cooperative Oncology Group Performance Status of 0 or 1

Must not have

Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Active, known or suspected autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, BMS-986288, alone and with Nivolumab, to see if they are safe and tolerable for patients with advanced solid tumors. The goal is to help the immune system fight cancer more effectively.

Who is the study for?

This trial is for adults with certain advanced solid tumors that have grown or returned after standard treatment. Participants must be fairly active and healthy otherwise (good performance status), and have at least one tumor that can be biopsied.

What is being tested?

The study is testing BMS-986288, an investigational immunotherapy, alone and in combination with Nivolumab to see if they are safe and effective for treating advanced cancers.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapies such as fatigue, skin reactions, inflammation of organs like the lungs or intestines, flu-like symptoms, and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread, can't be removed by surgery, and has a tumor that can be biopsied.

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I am fully active or can carry out light work.

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My cancer returned or worsened after 1 standard treatment.

Exclusion Criteria

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

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My cancer has not spread to my brain as the only site.

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I have an autoimmune disease.

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I have a cancer that needs immediate treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2C: BMS-986288 in combination with Nivolumab and RegorafenibExperimental Treatment3 Interventions

Group II: Arm B: BMS-986288 in combination with NivolumabExperimental Treatment2 Interventions

Group III: Arm A: BMS-986288 MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986288

2019

Completed Phase 2

~220

Nivolumab

2014

Completed Phase 3

~5220

Regorafenib

2014

Completed Phase 2

~1630

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

Immune checkpoint inhibitors, such as Nivolumab, work by targeting proteins that regulate the immune system's response to cancer cells. Nivolumab inhibits the PD-1 protein, which normally suppresses T-cell activity. By blocking PD-1, Nivolumab enables T-cells to better recognize and attack cancer cells. This mechanism is important for cancer patients as it can lead to more effective and long-lasting responses, improving survival rates and quality of life compared to traditional treatments.

Toward precision medicine in inflammatory breast cancer.Understanding Immune Checkpoint Inhibitors for Effective Patient Care.