Study on Ficerafusp Alfa and Pembrolizumab Before Surgery for Treatable Head and Neck Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07465276

Provider View

This clinical trial is testing the safety and effectiveness of combining two drugs, ficerafusp alfa and pembrolizumab, before surgery in patients with treatable, high-risk squamous cell carcinoma of the head and neck that is PD-L1 positive.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if the combination of ficerafusp alfa and pembrolizumab, given before surgery, is safe and effective in controlling high-risk squamous cell carcinoma of the head and neck. Ficerafusp alfa is an experimental drug, while pembrolizumab is already approved for this type of cancer. Participants will undergo various procedures, including blood tests, scans, and biopsies, to monitor their health and the treatment's impact. About 32 people are expected to participate in this study, which is supported by Bicara Therapeutics.

Description

This study is open-label and non-randomized, meaning all participants will receive the same treatment without being randomly assigned to different groups. It is a phase 2 trial focusing on the safety and effectiveness of ficerafusp alfa combined with pembrolizumab before surgery in patients with high-risk, PD-L1 positive squamous cell carcinoma of the head and neck. While pembrolizumab is approved for this cancer, ficerafusp alfa is still experimental. Participants will be screened for eligibility and will have regular clinic visits, blood and urine tests, tumor biopsies, and imaging scans like CT, MRI, or PET scans. The study aims to see if this combination can help control the cancer before surgery. Bicara Therapeutics is providing the investigational drug ficerafusp alfa for this study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced squamous cell carcinoma of the head and neck, specifically from the oral cavity, oropharynx (if HPV-negative), larynx, or hypopharynx.
  • Cancer must be treatable with surgery at the start of the study.
  • Must have a specific stage of cancer as defined by medical guidelines.
  • Tumor must be PD-L1 positive with a CPS score of 1 or higher.
  • Must be willing to provide blood and tissue samples before treatment and during surgery.
  • Must be 18 years or older.
  • Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ and blood function based on specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
  • Men must agree to use effective contraception during the study and for a specified period after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have recurrent or metastatic head and neck cancer or very early-stage cancer.
  • Cannot have HPV-associated oropharyngeal cancer.
  • Cancer must be operable at the start of the study.
  • Cannot have a performance status of 2 or greater.
  • Cannot have had prior treatment with certain cancer therapies.
  • Cannot have a significant risk of bleeding during surgery.
  • Cannot have an active autoimmune disease requiring treatment in the past 2 years.
  • Cannot have an active infection requiring hospitalization or intravenous treatment recently.
  • Cannot have certain psychiatric or substance abuse disorders.
  • Cannot have active hepatitis B or C infections unless under control.
  • Cannot have a history of HIV.
  • Cannot have had an organ transplant requiring immunosuppression.
  • Cannot have another cancer diagnosis within the past 2 years, with some exceptions.
  • Cannot be on certain medications that suppress the immune system recently.
  • Cannot have received a live vaccine recently.
  • Cannot be pregnant or breastfeeding.
  • Must be willing to provide samples for research.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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