What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, and myelosuppression. Targeted therapies like cetuximab may lead to skin rashes, diarrhea, and infusion reactions. Immunotherapies such as nivolumab can result in immune-related adverse events, including pneumonitis, colitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific treatment and patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly focusing on immunotherapies and targeted therapies. Pembrolizumab, an anti-PD-1 antibody, has been approved for various solid tumors, including melanoma and non-small cell lung cancer, due to its ability to enhance the immune response against cancer cells. Similarly, nivolumab, another anti-PD-1 antibody, has been approved for melanoma, renal cell carcinoma, and other cancers. Targeted therapies like cetuximab, an EGFR inhibitor, have been approved for head and neck cancers and colorectal cancer. These treatments, which modulate the immune system or target specific molecular pathways, are similar in approach to investigational drugs like BMS-986315.

What other types of research exist?

Promising alternatives to BMS-986315 for solid tumor patients include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 antibody used in various solid tumors, 2) Nivolumab (Opdivo) - another anti-PD-1 antibody with broad applications in solid tumors, 3) Atezolizumab (Tecentriq) - an anti-PD-L1 antibody used in multiple solid tumors, 4) Cabozantinib (Cabometyx) - a tyrosine kinase inhibitor effective in medullary thyroid cancer and other solid tumors, and 5) Infigratinib (Truseltiq) - an FGFR-selective tyrosine kinase inhibitor for cholangiocarcinoma. These therapies have shown promising results in clinical trials and are viable options for treatment in 2024.

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Monoclonal Antibodies

BMS-986315 + Immunotherapy for Advanced 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

Eastern cooperative oncology group performance status of 0 or 1

Participants must have histologic confirmation of advanced squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1

Must not have

History of or with active interstitial lung disease or pulmonary fibrosis

Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug called BMS-986315 alone and with other cancer treatments, nivolumab and cetuximab, in patients with advanced solid tumors. These patients have cancers that are hard to treat with standard methods. The treatments work by either helping the immune system fight the cancer or stopping the cancer cells from growing. Cetuximab has been used in various cancer treatments.

Who is the study for?

This trial is for adults with advanced solid tumors, specifically head and neck, lung, or kidney cancer. They should be relatively healthy (good performance status) and women must use birth control. Participants should have tried standard treatments including PD-(L)1 inhibitors but can't join if they have autoimmune diseases, previous anti-NKG2A study participation, need steroids/immunosuppressants regularly, drug allergies, lung disease/fibrosis or serious heart issues.

What is being tested?

The study tests BMS-986315 alone and combined with either nivolumab or cetuximab in patients with advanced solid tumors. It aims to see how well these treatments work on their own or together against different types of cancer by measuring the changes in tumor size using established criteria.

What are the potential side effects?

Potential side effects include immune-related reactions due to nivolumab that could affect organs like the lungs or intestines; skin reactions from cetuximab; plus common drug side effects such as fatigue, nausea and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I have advanced cancer in the head, neck, lung, or kidney with measurable disease.

Exclusion Criteria

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

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I have or had lung scarring or interstitial lung disease.

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I am on steroids or other drugs that affect my immune system.

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I have serious heart problems that are not under control.

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

3Treatment groups

Experimental Treatment

Group I: BMS-986315 + nivolumabExperimental Treatment2 Interventions

Group II: BMS-986315 + cetuximabExperimental Treatment2 Interventions

Group III: BMS-986315Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~4960

cetuximab

2000

Completed Phase 3

~7290

0 / 5Eligibility 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 treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as monoclonal antibodies and small molecule inhibitors, specifically target cancer cell proteins or pathways, minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors like nivolumab, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment with manageable side effects, and it informs the development of new therapies like BMS-986315, which may offer more precise and effective treatment options.

Quantifying Risk Pathway Crosstalk Mediated by miRNA to Screen Precision drugs for Breast Cancer Patients.

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Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,678 Previous Clinical Trials

4,125,337 Total Patients Enrolled

Media Library

BMS-986315 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04349267 — Phase 1 & 2

Solid Tumors Research Study Groups: BMS-986315 + nivolumab, BMS-986315 + cetuximab, BMS-986315

Solid Tumors Clinical Trial 2023: BMS-986315 Highlights & Side Effects. Trial Name: NCT04349267 — Phase 1 & 2

BMS-986315 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349267 — Phase 1 & 2

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