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

Sponsor: University of California, San Diego

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03993353

Provider View

This clinical trial is testing a combination of two drugs, tadalafil and pembrolizumab, to see if they are safe and effective in treating advanced head and neck cancer that has returned or spread.

Patient Parameters

Program Overview

The study aims to find out if using tadalafil together with pembrolizumab can safely and effectively treat advanced head and neck cancer. Researchers believe that combining these two drugs might work better than using pembrolizumab alone because they target different pathways that help the immune system fight cancer.

Description

This trial is exploring a new treatment approach for head and neck cancer that has come back or spread to other parts of the body. The treatment combines two drugs: tadalafil, which is usually used to treat erectile dysfunction, and pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells. In animal studies, this combination has shown promise in being more effective than using either drug alone. The trial will test if this combination can be safely given to patients and if it can improve treatment outcomes compared to using pembrolizumab by itself.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have recurrent or metastatic squamous cell carcinoma of the head and neck.
  • Have measurable cancer that can be tracked.
  • Have a life expectancy of more than 12 weeks.
  • Have normal organ and bone marrow function.

Exclusion Criteria

  • Have previously been treated with PD-1 or PD-L1 inhibitors for recurrent or metastatic cancer.
  • Have uncontrolled cancer that has spread to the brain (stable brain metastases are allowed).
  • Have an active autoimmune disease.
  • Have received chemotherapy within 28 days or monoclonal antibodies within 8 weeks before starting the study treatment.
  • Have used tadalafil or similar drugs daily for a month or more within 3 months before joining the trial.
  • Are currently using other long-acting PDE5 inhibitors.
  • Have a known severe allergy to tadalafil or its ingredients.
  • Are currently taking nitrates or certain other medications that interact with tadalafil.
  • Have a history of low blood pressure, vision or hearing loss related to tadalafil or similar drugs.
  • Have hereditary eye disorders like retinitis pigmentosa.
  • Have had a stroke in the past 6 months.
  • Have had a heart attack in the past 3 months or have uncontrolled heart conditions.
  • Have certain heart obstructions or angina requiring specific treatments.
  • Are pregnant or breastfeeding (a negative pregnancy test is required for women who can become pregnant).
  • Have a history of organ transplantation.
  • Have a known history of HIV or active hepatitis B or C infections.

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