Study on Pepinemab and Pembrolizumab for Recurrent or Metastatic Head and Neck Cancer

Sponsor: Vaccinex Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04815720

Provider View

This clinical trial is testing a new combination of drugs, pepinemab and pembrolizumab, to see if they are safe and effective as a first treatment for patients with head and neck cancer that has come back or spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to find out if the combination of pepinemab and pembrolizumab is safe and can be tolerated by patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It will also determine the best dose for future studies. The trial includes two phases: a safety phase to test the combination's safety and a dose expansion phase to see how well it works in shrinking tumors.

Description

This study is exploring the safety and effectiveness of combining two drugs, pepinemab and pembrolizumab, as a first treatment for patients with head and neck cancer that has returned or spread. The trial is divided into two parts:

  1. Safety Run-in Phase: This part will test the safety and tolerability of the drug combination in a small group of patients to find the best dose for the next phase. Patients will receive pepinemab through an IV at different doses and pembrolizumab at a fixed dose every three weeks.

  2. Dose Expansion Phase: This part will involve more patients to see how well the drug combination works in shrinking tumors. The study will measure how long patients live without the cancer getting worse and how long the treatment's effects last.

Patients will have regular check-ups and scans to monitor their cancer and overall health. The study will also look at how the drugs interact with the body and any changes in cancer markers.

Participants will be followed for up to two years after treatment to track their survival and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to provide written consent to participate.
  • Must have confirmed head and neck squamous cell carcinoma (HNSCC) in specific areas like the oropharynx or larynx.
  • Must have a specific test (PD-L1) done within 6 months of joining the study.
  • Must have measurable cancer that can be tracked by scans.
  • Cancer must be advanced, recurrent, or metastatic and not treatable by local therapies.
  • Must have a good performance status (ECOG 0 or 1).
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate blood cell counts and organ function.
  • HIV-positive patients must have controlled infection and be on stable antiretroviral therapy.
  • Must have tissue samples available for testing.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception.

Exclusion Criteria

  • Cancer of the nasopharynx.
  • Previous systemic treatment for recurrent or metastatic HNSCC, unless completed over 6 months ago.
  • Recent investigational therapy or radiation therapy.
  • Primary immunodeficiency or need for immunosuppressive therapy.
  • Active autoimmune conditions requiring treatment in the past 2 years.
  • Active brain metastases unless treated and stable.
  • Recent radiotherapy or other cancers within the past 2 years, except certain skin or cervical cancers.
  • History of organ transplants or severe lung conditions.
  • Active infections or pregnancy.
  • Previous treatment with similar drugs.
  • History of certain viral infections unless controlled.
  • Recent live vaccines or substance abuse.
  • Medical conditions that outweigh potential benefits of the trial.
  • Inability to comply with study requirements.

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