What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) include chemotherapies like docetaxel and targeted therapies such as cetuximab and pembrolizumab. These treatments can cause a range of side effects. Docetaxel is associated with neutropenia, febrile neutropenia, and peripheral neuropathy. Cetuximab can lead to severe skin reactions, hypomagnesemia, and infusion-related reactions. Pembrolizumab, an immune checkpoint inhibitor, may cause immune-related adverse events including colitis, pneumonitis, and endocrinopathies. Combination therapies, such as those involving nivolumab, can also result in compounded side effects from each agent, including fatigue, rash, and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for Squamous Cell Carcinoma (SCC) include immunotherapies and chemotherapies. Notably, nivolumab, an immune checkpoint inhibitor, has been approved for various cancers, including SCC, often in combination with other agents. Docetaxel, a chemotherapy drug, is also approved for SCC and is used in combination with other treatments. Cemiplimab, another immune checkpoint inhibitor, has shown efficacy in locally advanced cutaneous SCC. These treatments are similar to those being studied in the BMS-986340 trial, which explores the use of novel therapeutic agents in combination with nivolumab or docetaxel for advanced solid tumors.

What other types of research exist?

Promising novel alternatives to BMS-986340 for Squamous Cell Carcinoma patients include: 1) EMD 1201081, a TLR9 agonist, in combination with cetuximab, which has shown antitumor activity in recurrent/metastatic SCC of the head and neck. 2) BMS-690514, an oral tyrosine kinase inhibitor targeting EGFR, HER-2, HER-4, and VEGFRs, which has demonstrated antitumor activity in advanced solid tumors. These agents represent potential options for SCC treatment in 2024.

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Other

BMS-986340 + Nivolumab/Docetaxel for Cancer

Phase 1 & 2

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

Eastern Cooperative Oncology Group Performance Status of 0 or 1

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.

Must not have

Prior organ or tissue allograft

Active, known, or suspected autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, BMS-986340, alone and with other cancer treatments (nivolumab and docetaxel) in patients with advanced solid tumors. The goal is to find out if it is safe and effective in treating these cancers.

Who is the study for?

This trial is for adults with advanced solid tumors who've tried, can't tolerate, or have no other treatment options. They must have measurable disease and provide tumor biopsies for analysis. Not eligible if they had recent major surgery, are pregnant/breastfeeding, have certain lung diseases or autoimmune conditions, untreated brain metastases, or need steroids/immunosuppressants.

What is being tested?

The study tests BMS-986340 alone and combined with Nivolumab (BMS-936558-01) or Docetaxel in patients with various advanced cancers to find safe doses and see how well they work. It's the first time BMS-986340 is being given to humans in this setting.

What are the potential side effects?

Potential side effects may include typical reactions from cancer therapies such as fatigue, nausea, allergic responses to the drugs administered during infusion sessions; organ-specific inflammation; blood cell count changes; 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 a tumor that can be measured and biopsied, not just with a fine needle or from bone.

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My cancer has worsened 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 have received an organ or tissue transplant from another person.

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I have an autoimmune disease.

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I have or had lung scarring or interstitial lung disease.

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My cancer originated in my brain or spinal cord.

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I have serious heart problems that are not under control.

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I have not had major surgery in the last 4 weeks.

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I am not pregnant or breastfeeding.

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I have brain metastases that have not been treated.

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My cancer has spread to the lining of my brain and spinal cord.

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I haven't taken steroids or immunosuppressants in the last 14 to 30 days.

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

5Treatment groups

Experimental Treatment

Group I: Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental Treatment2 Interventions

Group II: Part 2A: BMS-986340 Dose ExpansionExperimental Treatment1 Intervention

Group III: Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimental Treatment2 Interventions

Group IV: Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental Treatment2 Interventions

Group V: Part 1A: BMS-986340 Dose EscalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

0 / 13Eligibility 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 Squamous Cell Carcinoma (SCC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as those inhibiting the epidermal growth factor receptor (EGFR), work by blocking specific molecules involved in tumor growth and progression. Immunotherapies, like nivolumab, enhance the body's immune response against cancer cells by inhibiting checkpoints that suppress immune activity. Chemotherapy agents, such as docetaxel, disrupt cell division and induce apoptosis in rapidly dividing cancer cells. These mechanisms are crucial for SCC patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and providing options when resistance to one type of treatment develops.

Identification and validation of novel prognostic markers in Renal Cell Carcinoma.Emerging biological treatments for uterine cervical carcinoma.Novel agents in the treatment of lung cancer: Fourth Cambridge Conference.