Tazemetostat + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDouglas Adkins, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.

Research Team

Douglas Adkins, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Adults with recurrent or metastatic head and neck squamous cell carcinoma resistant to treatments like pembrolizumab or nivolumab. Participants must have measurable disease, be in good physical condition (ECOG ≤ 1), have normal organ function, and not be pregnant. They should agree to use contraception during the trial.

Inclusion Criteria

My kidney function is within the required range.

My cancer is PD-L1 positive based on specific tests.

Total bilirubin ≤ 1.5 x IULN

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Exclusion Criteria

I haven't taken high doses of steroids or had severe autoimmune issues with PD-1 treatments.

Investigational therapy within 21 days of treatment start.

I have previously been treated with an EZH2 inhibitor.

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Treatment Details

Interventions

Pembrolizumab (Checkpoint Inhibitor)
Tazemetostat (Epigenetic inhibitor)

Trial OverviewThe study is testing tazemetostat combined with pembrolizumab in two phases: Phase 1 determines the safest dose, while Phase 2 checks how well this combination works for patients whose tumors continued to grow despite previous treatment with PD-1 inhibitors.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase I: Tazemetostat + PembrolizumabExperimental Treatment2 Interventions

* Cycle 1 over 5 weeks (35 days). Subsequent cycles over 3 weeks (21 days). * Tazemetostat tablet twice per day Days 1-35 of Cycle 1, then Days 1-21 of subsequent cycles. Dose of tazemetostat will depend on dose level assigned * Pembrolizumab 200mg intravenous Day 15 of Cycle 1, then Day 1 of subsequent cycles.

Group II: Phase 2: Tazemetostat + PembrolizumabExperimental Treatment2 Interventions

* Cycle 1 over 5 weeks (35 days). Subsequent cycles over 3 weeks (21 days). * Tazemetostat tablet twice per day Days 1-35 of Cycle 1, then Days 1-21 of subsequent cycles. Dose of tazemetostat will depend of recommended phase 2 determined in Phase I portion of study. * Pembrolizumab 200mg intravenous Day 15 of Cycle 1, then Day 1 of subsequent cycles.