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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions

RP2D of valemetostat in combination with pembrolizumab

Group II: Arm 1Experimental Treatment2 Interventions

Pembrolizumab + de-escalating doses of valemetostat

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,106 Total Patients Enrolled

Vassiliki Saloura, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Pembrolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05879484 — Phase 1 & 2

Lung Cancer Research Study Groups: Arm 1, Arm 2

Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05879484 — Phase 1 & 2

Pembrolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05879484 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this clinical investigation?

"The primary outcome of this clinical trial, which will be assessed over a period from study commencement to progression or two-years following treatment initiation, is the safety profile of valemetostat in combination with pembrolizumab. Secondary outcomes encompass overall survival (OS) relative to historical controls treated solely with pembrolizumab every nine weeks before progression and six weeks after; 6-month progression free survival (PFS) rate against said control group measured at the conclusion of six months' observation; and PFS amongst participants receiving both drugs compared to those only taking pembrolizumab monitored until 2 years post-"

Answered by AI

Does this research include elderly individuals in its participant pool?

"The trial specifications mention that participants have to be between 18 and 120 years old. Meanwhile, 132 trials are available for patients below 18 while 4345 studies exist for individuals over 65."

Answered by AI

Does this research currently offer enrollment opportunities?

"According to the clinicaltrials.gov database, this trial is not actively seeking subjects at present; it was originally posted on June 5th 2023 and last updated on May 30th 2023. Although recruitment has temporarily halted for this study, there are currently 4378 other studies open for volunteers."

Answered by AI

Who is eligible to enroll in this clinical research study?

"Eligibility for this medical trial is determined by the presence of head and neck squamous cell carcinoma, as well as a patient's age which must be between 18-120 years old. Currently, 40 participants are being sought after."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS

2024. "Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05879484.