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Checkpoint Inhibitor
Tazemetostat + Pembrolizumab for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis: Phase 1 specific: recurrent or metastatic head and neck cancer, inclusive of cancers that originate in the head and neck, except central nervous system (CNS) cancers.
Serum creatinine <1.5x ULN or Creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of cycle 1 for all phase i participants (estimated to be 9 months)
Awards & highlights
Study Summary
This trial will test tazemetostat, in combination with pembrolizumab or nivolumab, in patients with recurrent or metastatic head and neck squamous-cell carcinoma who are resistant to pembrolizumab or nivolumab.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects of tazemetostat and pembrolizumab may include immune system reactions, fatigue, nausea, blood count changes, liver enzyme alterations, and issues related to fertility. Specific side effects will vary between individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recurrent or metastatic cancer that started in my head or neck, but not in my brain or spinal cord.
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My kidney function is within the required range.
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My disease cannot be cured with surgery or radiation, or I am not eligible for these treatments.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer is a recurring or spreading type in my head or neck area.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of cycle 1 for all phase i participants (estimated to be 9 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of cycle 1 for all phase i participants (estimated to be 9 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) assessed by iRECIST (Phase 2 only)
Recommended phase 2 dose of tazemetostat in combination with a fixed dose of pembrolizumab (Phase I only)
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall survival (OS)
+1 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Industry Sponsor
33 Previous Clinical Trials
2,841 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,696 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
11 Previous Clinical Trials
550 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high doses of steroids or had severe autoimmune issues with PD-1 treatments.My kidney function is within the required range.My cancer is PD-L1 positive based on specific tests.I have previously been treated with an EZH2 inhibitor.I have had an organ or stem cell transplant from a donor.My disease cannot be cured with surgery or radiation, or I am not eligible for these treatments.I had cancer before, but I finished treatment over a year ago and am now cancer-free.My cancer has worsened on pembrolizumab or nivolumab treatment in the past 6 months.My brain metastases are stable, not new or growing, and I've been on a steady dose of steroids.I agree to use effective birth control during and for 6 months after the study.My blood tests show my organs and bone marrow are working well.I have recurrent or metastatic cancer that started in my head or neck, but not in my brain or spinal cord.I haven't had radiation, chemotherapy, or targeted therapy in the last 14 days.I cannot take pills by mouth.I am allergic to medications similar to tazemetostat or pembrolizumab.I do not have any uncontrolled illnesses like infections or heart problems.My cancer is a recurring or spreading type in my head or neck area.I am 18 years old or older.My cancer can be measured by scans or x-rays.I am fully active and can carry on all my pre-disease activities without restriction.I have an autoimmune disease and have needed strong medication for it in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Tazemetostat + Pembrolizumab
- Group 2: Phase 2: Tazemetostat + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the approved indications for Pembrolizumab?
"Pembrolizumab is an immunotherapy medication that can be used to treat patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Are there extensive Pembrolizumab clinical trials being conducted globally?
"Pembrolizumab is being researched in 1018 clinical trials, with 124 of those studies in Phase 3. While some of the research for Pembrolizumab is happening in Houston, Texas, there are 37297 locations around the world where these trials are taking place."
Answered by AI
Are people still being accepted into this research project?
"This study, which is currently seeking patients, was first posted on clinicaltrials.gov on April 14th 2021. It was last updated on October 26th 2022."
Answered by AI
What are the goals of this experiment?
"The primary outcome that Epizyme, Inc. will measure over the course of this study is objective response rate (ORR) as assessed by iRECIST. Additionally, this trial will assess secondary outcomes including incidence of adverse events, progression-free survival (PFS), and overall survival (OS)."
Answered by AI
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