What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as anti-platelet therapy and anti-PD-1 immunotherapy, have distinct side effect profiles. Anti-platelet therapy, which inhibits platelet aggregation, can lead to increased bleeding risks, including epistaxis (nosebleeds) and gastrointestinal bleeding. Anti-PD-1 immunotherapy, which blocks the PD-1 pathway to enhance the immune response, is associated with immune-related adverse events such as skin toxicities (e.g., rash, pruritus), gastrointestinal issues (e.g., diarrhea, colitis), and endocrine disorders (e.g., thyroid dysfunction). Additionally, patients may experience fatigue, pneumonitis, and infusion-related reactions.

What prior FDA approvals exist?

Pembrolizumab, an anti-PD-1 immunotherapy, has been FDA-approved for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). It works by blocking the PD-1 pathway, thereby enhancing the immune response against cancer cells. Another similar drug, cetuximab, targets the epidermal growth factor receptor (EGFR) and has been used in combination with chemotherapy for HNSCC. While anti-platelet therapies are not specifically approved for head and neck cancers, their combination with immunotherapies like pembrolizumab is being explored in clinical trials to potentially improve treatment outcomes.

What other types of research exist?

Promising novel alternatives for head and neck cancer treatment in 2024 include: 1) Combination therapies involving other immune checkpoint inhibitors such as CTLA-4 inhibitors (e.g., ipilimumab) combined with PD-1/PD-L1 inhibitors. 2) Targeted therapies like EGFR inhibitors (e.g., cetuximab) in combination with chemotherapy. 3) Novel agents targeting tumor microenvironment and angiogenesis, such as bevacizumab. 4) Personalized cancer vaccines and adoptive T-cell therapies, which are tailored to the patient's specific tumor antigens. 5) Investigational drugs in clinical trials, including those targeting new molecular pathways and biomarkers specific to head and neck cancers.

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PD-1 Inhibitor

Pembrolizumab + Anti-platelet Therapy for Head and Neck Cancer

Phase 1

Recruiting

Led By John Kaczmar, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Subject has adequate renal function, defined as estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula

Subject has pathologic confirmation of recurrent or metastatic HNSCC, regardless of HPV status

Must not have

Subject is receiving anticoagulation. Subjects must have a washout period of 7 days from registration

Subjects requiring re-irradiation to head and neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

This trial is testing if combining two treatments works better than using one treatment alone for patients with head and neck cancer that has come back or spread. The combination aims to improve the immune system's ability to fight the cancer.

Who is the study for?

Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that expresses PD-L1 or has progressed after chemotherapy can join. They must have a life expectancy of at least 3 months, measurable disease, good performance status, and adequate organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.

What is being tested?

The trial is testing if combining Pembrolizumab (an immunotherapy drug) with anti-platelet drugs like acetylsalicylic acid and Clopidogrel improves immune response in patients compared to just using immunotherapy alone.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, bleeding due to anti-platelet therapy, fatigue from Pembrolizumab, as well as potential liver or kidney issues related to the body's reaction to these medications.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys work well enough, with a creatinine clearance over 30 mL/min.

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My cancer has returned or spread and it's confirmed by tests.

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My liver is functioning well, based on recent tests.

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I can take care of myself and am up and about more than half of my waking hours.

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My tumor is PD-L1 positive or my cancer worsened after platinum chemotherapy.

Exclusion Criteria

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

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I am on blood thinners but can stop them for 7 days.

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I need another round of radiation therapy to my head or neck.

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My head or neck cancer is affecting my carotid artery or its branches.

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I have a draining wound or fistula in my head or neck area.

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I have an aneurysm in my head or neck from surgery.

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I currently have a stomach or intestinal ulcer.

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I have a condition that causes excessive bleeding.

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I have a serious heart condition.

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I am not pregnant or nursing.

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I am not on any immunosuppressive treatments or cancer therapies within the last 14 days.

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I have a condition that causes me to bleed easily.

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I have received an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effect of Pembro + antiplatelet on major cellular parameters

Secondary study objectives

Effect of Pembro + antiplatelets on immunologic markers

Frequency of adverse events reported

Tumor response rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment3 Interventions

Group 2 will be treated with Regimen B, followed by Regimen A. Regimen B is pembrolizumab alone for 6 weeks. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks.

Group II: Group 1Experimental Treatment3 Interventions

Group 1 will be treated with Regimen A, followed by Regimen B. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks. Regimen B is pembrolizumab alone for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clopidogrel

2010

Completed Phase 4

~9160

acetylsalicylic acid

2016

Completed Phase 4

~2190

Pembrolizumab

2017

Completed Phase 2

~2070

0 / 17Eligibility 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 Head and Neck Cancers include anti-platelet therapy and anti-PD-1 immunotherapy. Anti-platelet therapy inhibits platelet aggregation, which can help prevent tumor cells from evading the immune system and spreading. Anti-PD-1 immunotherapy blocks the PD-1 pathway, enhancing the immune system's ability to recognize and destroy cancer cells. These treatments are significant for patients as they provide targeted strategies to boost the body's natural defenses, potentially improving treatment efficacy and reducing side effects compared to conventional therapies.

Immunotherapeutic Approaches to Head and Neck Cancer.