Phase 3 Study Comparing Petosemtamab and Pembrolizumab with Pembrolizumab Alone for First-line Treatment of Head and Neck Cancer

Sponsor: Merus N.V.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06525220

Provider View

This clinical trial is testing whether adding the drug petosemtamab to pembrolizumab is more effective than using pembrolizumab alone for treating head and neck cancer that has returned or spread and is positive for PD-L1.

Patient Parameters

Program Overview

The study aims to find out if combining petosemtamab with pembrolizumab works better than pembrolizumab alone in treating head and neck cancer that has come back or spread. This is for patients whose cancer cells have a marker called PD-L1. Participants should not have had previous treatments for cancer that has spread, but treatments for earlier stages are allowed if they were completed at least 6 months ago. Patients who have had certain other cancer treatments are not eligible.

Description

This Phase 3 study is designed to compare the effectiveness and safety of a combination of two drugs, petosemtamab and pembrolizumab, against pembrolizumab alone in treating head and neck cancer that has returned or spread. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants should not have received any previous systemic therapy for cancer that has spread, but previous treatments for locally advanced cancer are allowed if they were completed at least 6 months ago. Patients who have had treatments targeting PD-(L)1 or EGFR are not eligible, except for those who had cetuximab with radiation and their cancer returned more than a year later.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form before starting any study procedures.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of head and neck cancer that has spread or returned and cannot be treated with surgery.
  • Cancer must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
  • Must be eligible to receive pembrolizumab as a first treatment, with tumors showing PD-L1 expression.
  • Must not have had previous systemic therapy for cancer that has spread.
  • Must provide a new tumor sample or have an existing sample available.
  • Must have measurable disease as determined by scans.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of at least 12 weeks.
  • Must have a heart function of at least 50% or higher.
  • Must have adequate organ function as defined by the study protocol.

Exclusion Criteria

  • Have untreated or symptomatic brain metastases or need treatment for brain symptoms within 21 days of starting the study.
  • Have cancer spread to the membranes around the brain and spinal cord.
  • Have had any cancer treatment within 4 weeks of starting the study.
  • Have had major surgery or radiation within 3 weeks of starting the study.
  • Have significant side effects from previous cancer treatments, except for hair loss.
  • Have allergies to the study drugs.
  • Have serious heart conditions or recent heart attack.
  • Have had other cancers, except for certain low-risk cancers, within the past 3 years.
  • Have difficulty breathing at rest or need continuous oxygen therapy.
  • Have serious illnesses or medical conditions, including uncontrolled infections or significant lung, metabolic, or psychiatric disorders.
  • Have known infectious diseases as per the study protocol.
  • Are pregnant or breastfeeding.
  • Have an immune deficiency or are on immunosuppressive therapy within 7 days of starting the study.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have a primary tumor in the nasopharynx or sinonasal area.

Other criteria may apply as defined by the study protocol.

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