What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly immune modulators and targeted therapies, include fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies like masitinib may also cause asthenia, nausea, edema, and diarrhea. While these side effects are often manageable, they can sometimes be severe.

What prior FDA approvals exist?

The FDA has approved several immune modulators and targeted therapies for the treatment of solid tumors. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various cancers, including melanoma and renal cell carcinoma. Ipilimumab, a CTLA-4 inhibitor, is approved for melanoma. Bevacizumab, an anti-VEGF antibody, is used in combination with chemotherapy for certain cancers, including mesothelioma. These approvals highlight the efficacy of immune checkpoint inhibitors and targeted therapies in managing advanced solid tumors.

What other types of research exist?

Promising novel alternatives to BMS-986360 for solid tumor patients include: <ol> <li>Nivolumab: An immune checkpoint inhibitor that has shown efficacy in various solid tumors, including in combination with other therapies.</li> <li></li> </ol> Pembrolizumab: Another immune checkpoint inhibitor with demonstrated activity in multiple solid tumors. 3. Regorafenib: A multitargeted kinase inhibitor with some activity in advanced solid tumors. 4. Cabozantinib: A tyrosine kinase inhibitor targeting VEGFR and other kinases, showing limited activity in advanced solid tumors. 5. Lenvatinib: Often used in combination with other agents like etoposide and ifosfamide, showing some efficacy in advanced solid tumors.

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Monoclonal Antibodies

BMS-986360 + Chemotherapy/Nivolumab for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986360, alone or with other treatments, in patients with advanced cancers to see if it is safe and can help fight the disease.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including lung cancer and breast cancer, who have tried standard treatments without success. They must be in good physical condition (ECOG 0 or 1) and have a tumor that can be biopsied. People with primary brain tumors or only brain metastases, recent steroid use, other active cancers within the last two years, or specific genetic mutations treatable by targeted therapy are excluded.

What is being tested?

The study tests BMS-986360 alone and combined with chemotherapy drugs like Docetaxel and Capecitabine or the immunotherapy drug Nivolumab in patients with advanced solid tumors. It aims to find out how safe these treatments are and how well they're tolerated when given together.

What are the potential side effects?

Possible side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; immune-related issues from Nivolumab like skin rash or inflammation of organs; plus any unknown risks from the new drug BMS-986360.

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

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: BMS-986360 + NivolumabExperimental Treatment2 Interventions

Group II: BMS-986360 + DocetaxelExperimental Treatment2 Interventions

Group III: BMS-986360 + CapecitabineExperimental Treatment2 Interventions

Group IV: BMS-986360Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Docetaxel

1995

Completed Phase 4

~6550

Nivolumab

2015

Completed Phase 3

~4010

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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 include immune modulators and targeted cancer therapies. Immune modulators, such as nivolumab, enhance the body's immune response by blocking proteins like PD-1 or PD-L1, which tumors use to evade immune detection. Targeted cancer therapies focus on specific molecules involved in tumor growth and progression, such as tyrosine kinases. These treatments are important for solid tumor patients as they provide more precise and often less toxic alternatives to traditional chemotherapy, potentially leading to better outcomes and improved quality of life.