"QUAD SHOT" Radiotherapy with Pembrolizumab for Patients with Recurrent Head and Neck Cancer

Sponsor: University of Oklahoma

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04373642

Provider View

This clinical trial is testing the safety and effects of combining "QUAD SHOT" radiotherapy with the drug pembrolizumab for patients with head and neck cancer that has returned.

Patient Parameters

Program Overview

The study aims to find out if combining a special type of radiotherapy called "QUAD SHOT" with the drug pembrolizumab is safe and effective for patients whose head and neck cancer has come back. The treatment involves receiving pembrolizumab every three weeks and radiotherapy every four weeks, repeated over three cycles. Patients will also complete a survey, and the study may last up to two years.

Description

In this study, patients will receive a combination of pembrolizumab infusions and "QUAD SHOT" radiotherapy. Pembrolizumab will be given once every three weeks, and the radiotherapy will be administered every four weeks. This schedule is called a cycle, and each cycle lasts 28 days. Patients will undergo up to three cycles of this combination treatment, followed by pembrolizumab alone until the cancer progresses or side effects become too severe. Participants will also complete a survey during the study. The total duration of the study can be up to two years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide written informed consent before any study procedures.
  • Must have a confirmed diagnosis of squamous cell carcinoma in the head and neck area.
  • Cancer must have returned or spread and cannot be treated with surgery or other curative treatments.
  • At least six months must have passed since any previous radiotherapy.
  • Must have a measurable tumor.
  • Must provide smoking history.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential and their male partners must agree to use effective contraception during the study and for 90 days after the last treatment.
  • Male participants must agree to use contraception.

Exclusion Criteria

  • Have a different type of salivary gland cancer.
  • Have had another primary cancer, except for certain treated cancers with no active disease for at least five years.
  • Have had radiotherapy to the study cancer area within the last six months.
  • Cannot safely receive more radiotherapy due to previous treatments.
  • Have known conditions that make radiotherapy unsafe.
  • Have inadequate kidney function or cannot receive IV contrast.
  • Have previously received PD-1 or PD-L1 inhibitors.
  • Are using immunosuppressive medication, except for certain low-dose steroids.
  • Have unresolved side effects from previous cancer treatments.
  • Have had severe immune-related side effects from previous treatments.
  • Have active autoimmune disease within the past two years, except for certain conditions.
  • Have lung disease or active pneumonitis.
  • Have a history of immune system deficiency.
  • Have had an organ transplant.
  • Have uncontrolled illnesses or infections.
  • Have severe heart or lung conditions.
  • Are pregnant or breastfeeding, or not using effective birth control if of reproductive potential.

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