What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments for solid tumors, such as those involving nivolumab and ipilimumab, include fatigue, rash, diarrhea, and pruritus. More severe adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These side effects result from the immune system's activation and can vary in severity, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several immunotherapy agents for the treatment of solid tumors, focusing on immune checkpoint inhibitors. Nivolumab (Opdivo) and pembrolizumab (Keytruda) are PD-1 inhibitors approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. Ipilimumab (Yervoy), a CTLA-4 inhibitor, is also approved for melanoma and is often used in combination with nivolumab. These agents work by enhancing the body's immune response against cancer cells and have shown significant efficacy in treating advanced solid tumors.

What other types of research exist?

Promising novel alternatives to BMS-986408 for solid tumors include: 1) Pembrolizumab (Keytruda) - widely used in various cancers including melanoma, NSCLC, and others. 2) Nivolumab (Opdivo) - effective in melanoma, renal cell carcinoma, and NSCLC. 3) Atezolizumab (Tecentriq) - used in NSCLC and urothelial carcinoma. 4) Relatlimab combined with Nivolumab - showing promise in advanced melanoma. 5) Cabozantinib combined with Atezolizumab - effective in renal cell carcinoma. These agents have demonstrated significant efficacy and safety profiles in recent clinical trials.

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Other

BMS-986408 + Immunotherapy 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 with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)

Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Must not have

Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment

Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug called BMS-986408 alone and with two other drugs, nivolumab and ipilimumab, to find the safest dose and understand how it works in the body. It likely targets cancer patients who need new treatment options.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who haven't responded to or can't receive standard treatments. Melanoma patients must know their BRAF and NRAS mutation status. People taking steroids or other immune-suppressing drugs recently, those with certain gastrointestinal conditions, or untreated brain metastases cannot join.

What is being tested?

The study is testing the safety of a new drug called BMS-986408 alone and in combination with Nivolumab, as well as together with both Nivolumab and Ipilimumab. It aims to find the highest dose patients can take without serious side effects (MTD) and the best dose for future studies (RP2D).

What are the potential side effects?

Possible side effects include reactions related to the immune system since Nivolumab and Ipilimumab are immunotherapies that may cause inflammation in various organs. The specific side effects of BMS-986408 are being studied but could also involve similar immune-related issues.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma has been tested for BRAF and NRAS mutations.

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My cancer is advanced, cannot be surgically removed, and can be measured for treatment response.

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My cancer has grown or spread on scans after my last treatment.

Exclusion Criteria

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

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I haven't taken steroids or immunosuppressants in the last 30 days.

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I have had recent stomach or intestine problems or surgery that could affect how I absorb medication.

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I have brain metastases that have not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 3: BMS-986408 in combination with nivolumab and chemotherapyExperimental Treatment3 Interventions

Group II: Part 3: BMS-986408 in combination with nivolumabExperimental Treatment2 Interventions

Group III: Part 2: BMS-986408 in combination with rabeprazoleExperimental Treatment2 Interventions

Group IV: Part 2: BMS-986408 in combination with nivolumab and ipilimumabExperimental Treatment3 Interventions

Group V: Part 2: BMS-986408 in combination with nivolumab and chemotherapyExperimental Treatment3 Interventions

Group VI: Part 2: BMS-986408 in combination with nivolumabExperimental Treatment2 Interventions

Group VII: Part 1: BMS-986408 MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140

Rabeprazole

2017

Completed Phase 4

~4220

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

The most common treatments for solid tumors, particularly immunotherapy agents like BMS-986408, nivolumab, and ipilimumab, work by enhancing the body's immune response against cancer cells. These treatments are known as immune checkpoint inhibitors. They function by blocking proteins such as PD-1, PD-L1, and CTLA-4, which normally act as brakes on the immune system. By inhibiting these proteins, the treatments release the brakes, allowing T-cells to attack and destroy cancer cells more effectively. This mechanism is crucial for patients with solid tumors as it leverages the body's natural defenses to target and eliminate cancer, potentially leading to better outcomes and prolonged survival.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,678 Previous Clinical Trials

4,125,243 Total Patients Enrolled

Media Library

BMS-986408 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05407675 — Phase 1 & 2

Solid Tumors Research Study Groups: Part 2: BMS-986408 in combination with rabeprazole, Part 3: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and chemotherapy, Part 3: BMS-986408 in combination with nivolumab and chemotherapy, Part 1: BMS-986408 Monotherapy, Part 2: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and ipilimumab

Solid Tumors Clinical Trial 2023: BMS-986408 Highlights & Side Effects. Trial Name: NCT05407675 — Phase 1 & 2

BMS-986408 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05407675 — Phase 1 & 2

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