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PD-L1 Inhibitor

Pembrolizumab + Valemetostat for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Vassiliki Saloura, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must have disease amenable for biopsies and be willing to undergo these biopsies

Participants must have a diagnosis of specific types of cancer including locoregionally recurrent or metastatic squamous cell carcinoma of the head and neck, sinonasal carcinomas, and squamous non-small cell lung cancer

Must not have

History of autoimmune disease, prior malignancy, or uncontrolled infections

Pregnancy or uncontrolled intercurrent illness or situations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment start until 30 days after last dose of study agents.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 2 drugs to treat HPV-negative head and neck cancer. It includes physical exams, blood tests, imaging scans, and a biopsy. Treatment consists of pembrolizumab and valemetostat.

Who is the study for?

Adults with HPV-negative head and neck squamous cell carcinoma, sinonasal cancer, or squamous non-small cell lung cancer. They must have good organ function, be able to undergo biopsies, not be pregnant or breastfeeding, agree to use contraception, and sign a consent form. Excluded are those with autoimmune diseases, prior malignancies within a certain period, uncontrolled infections or illnesses.

What is being tested?

The PANTHERAS trial is testing the safety and effectiveness of combining pembrolizumab (an IV drug) with valemetostat (a daily oral tablet). Participants will receive treatments in cycles of 21 days for up to two years while their health is closely monitored through exams and tests.

What are the potential side effects?

Potential side effects include immune system reactions that can affect organs like the lungs or intestines; infusion-related reactions from pembrolizumab; fatigue; liver issues due to valemetostat; as well as possible blood disorders. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I am willing and able to have biopsies for my condition.

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I have been diagnosed with a specific type of cancer in the head, neck, or lungs.

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I meet the age and health condition requirements.

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I have a measurable disease and do not have HIV or hepatitis B/C.

Exclusion Criteria

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

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I have a history of autoimmune disease, cancer, or ongoing infections.

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I am not pregnant and do not have any uncontrolled illnesses.

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I am currently taking certain medications.

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I am on high-dose immunosuppressive therapy.

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I have been treated with EZH2 inhibitors before.

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I have a specific heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study start-30 days after last dose of study agents

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study start-30 days after last dose of study agents

This trial's timeline: 3 weeks for screening, Varies for treatment, and study start-30 days after last dose of study agents for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase II: Disease control rate (DCR)

Phase Ib: Recommended phase II dose (RP2D) of valemetostat in combination with pembrolizumab

Phase Ib: Safety of valemetostat in combination with pembrolizumab

Secondary study objectives

6-month progression free survival (PFS) rate in participants treated with valemetostat and pembrolizumab compared to historical controls treated with pembrolizumab alone

Clinical benefit rate (CBR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone

Objective response rate (ORR) in participants treated with valemetostat and pembrolizumab compared to historical controls with pembrolizumab alone

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