What side effects are associated with this type of intervention?

Pembrolizumab, a PD-1 inhibitor used in treating Oral Squamous Cell Carcinoma, commonly causes side effects such as fatigue, pruritus, pyrexia, and decreased appetite. Severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Setanaxib, a NOX1/4 inhibitor, may have oxidative stress-related side effects, though its profile is less well-documented. Combining these treatments may result in a unique side effect profile that requires careful monitoring.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), including Oral Squamous Cell Carcinoma (OSCC), particularly in patients with PD-L1 positive tumors. Other similar treatments include cetuximab, an EGFR inhibitor, and nivolumab, another PD-1 inhibitor, both of which have been approved for use in HNSCC. These approvals underscore the importance of immune checkpoint inhibitors and targeted therapies in managing OSCC.

What other types of research exist?

Promising novel alternatives for Oral Squamous Cell Carcinoma patients in 2024 include: 1) Budigalimab, a novel anti-PD-1 monoclonal antibody, which has shown efficacy in HNSCC. 2) Nivolumab, another PD-1 inhibitor, which has demonstrated effectiveness in various studies. 3) Atezolizumab, a PD-L1 inhibitor, which has been used in combination with chemotherapy for HNSCC. 4) Tislelizumab, a PD-1 inhibitor, which has shown promising results in clinical trials for HNSCC. These alternatives offer different mechanisms of action and potential benefits for patients.

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Monoclonal Antibodies

Setanaxib + Pembrolizumab for Head and Neck Cancer

Phase 2

Waitlist Available

Research Sponsored by Genkyotex Suisse SA

Eligibility Criteria Checklist

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

Must have

Measurable disease, in accordance with RECIST v1.1, and with tumour accessible and of sufficient volume for pre-treatment and on-treatment biopsy

Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or metastatic with or without nodal involvement, and with or without metastatic spread, and is not eligible for surgical resection

Must not have

Known active central nervous system metastases and/or carcinomatous meningitis

Serious chronic gastrointestinal conditions associated with diarrhoea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 26 months

Summary

This trial tests setanaxib and pembrolizumab in patients with head and neck cancer that has returned or spread. Setanaxib may stop cancer growth, and pembrolizumab helps the immune system fight cancer. Pembrolizumab is now used for various cancers including head and neck cancer.

Who is the study for?

Adults with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are candidates for first-line pembrolizumab treatment. They must have adequate organ function, known HPV status, measurable disease per RECIST v1.1, a life expectancy over 6 months, and an ECOG performance status of 0 or 1. Women must use effective contraception and have a negative pregnancy test; men should also agree to use contraception.

What is being tested?

The trial is testing the effectiveness of Setanaxib combined with Pembrolizumab versus a placebo with Pembrolizumab in shrinking tumors according to RECIST v1.1 criteria in patients with SCCHN. Participants will be randomly assigned to either receive Setanaxib or a placebo alongside standard Pembrolizumab therapy.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues like diarrhea, changes in blood tests reflecting liver and kidney function, potential impact on bone marrow leading to lower blood cell counts which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured and biopsied according to specific guidelines.

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My cancer has returned or spread and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have cancer that has spread to my brain or spinal cord.

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I have a long-term stomach or bowel condition that causes diarrhea.

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I have had serious blood disorders needing treatment.

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My heart condition is stable.

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I have been treated with pembrolizumab before.

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I have HIV or hepatitis B/C.

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I have never taken setanaxib or been in a setanaxib study before.

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I am currently on medication for an infection.

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I can provide informed consent and follow the study's requirements.

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I am legally unable to make my own decisions.

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I have recovered from side effects of previous treatments, except for hair loss.

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I haven't taken strong medication that affects liver enzymes in the last 21 days.

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I have an autoimmune disease that needed treatment in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Percentage Change in Tumour Size

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DoR)

Number of Participants with Adverse Events (AEs)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Setanaxib 800 mg and Pembrolizumab 200 mgExperimental Treatment2 Interventions

Participants will be administered Setanaxib 800 mg twice daily. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Group II: Placebo and Pembrolizumab 200 mgActive Control2 Interventions

Participants will be administered placebo throughout the 24 month treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Setanaxib

2022

Completed Phase 2

~140

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 16Eligibility 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 Oral Squamous Cell Carcinoma (OSCC) include targeted therapies and immunotherapies. Setanaxib, a NOX1/4 inhibitor, reduces oxidative stress and inflammation, which are key factors in cancer progression. Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway that tumors use to evade immune surveillance. These mechanisms are important for OSCC patients as they offer a dual approach: targeting the tumor microenvironment and boosting the immune response, potentially leading to more effective treatment outcomes.

Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.Targeted Therapy in Head and Neck Cancer: An Update on Current Clinical Developments in Epidermal Growth Factor Receptor-Targeted Therapy and Immunotherapies.Molecular genetics of head and neck cancer (Review).