Study on the Safety and Effectiveness of Danvatirsen and Pembrolizumab in Head and Neck Cancer

Sponsor: Flamingo Therapeutics NV

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05814666

Provider View

This clinical trial is testing a combination of two drugs, danvatirsen and pembrolizumab, to see if they are safe and effective in treating patients with head and neck cancer that has returned or spread. Some patients will receive both drugs, while others will receive pembrolizumab alone.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well danvatirsen works with pembrolizumab compared to pembrolizumab alone in treating head and neck cancer that has come back or spread. The study will involve two groups: two-thirds of the participants will receive both danvatirsen and pembrolizumab, and one-third will receive only pembrolizumab. The treatment will be given in cycles of 21 days, and patients will be monitored for up to 24 months or until they need to stop treatment for other reasons.

Description

This study is being conducted at multiple centers and is open to patients who meet certain criteria. After agreeing to participate, patients will undergo screening to ensure they are eligible. They will need to provide a sample of their tumor, either from a previous biopsy or a new one if possible. Eligible patients will be randomly assigned to receive either the combination of danvatirsen and pembrolizumab or pembrolizumab alone.

Treatment will be given in 21-day cycles, and patients will continue until they meet a reason to stop or reach 24 months of treatment. Those on the combination therapy may continue with danvatirsen alone after 24 months. Tumor assessments will be done every 6 weeks to monitor progress.

After stopping treatment, patients will have a follow-up visit to check for any side effects and will be monitored for survival every 12 weeks until the study ends or they withdraw consent.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Aged 18 years or older.
  • Have head and neck cancer that has returned or spread and cannot be cured with local treatment.
  • Have a measurable tumor.
  • Tumor must show PD-L1 expression.
  • Provide a tumor sample for testing.
  • Be in good general health with an ECOG score of 0 or 1.
  • Have adequate organ function and oxygen levels.
  • Women must not be pregnant or breastfeeding and must use birth control.
  • Men must be sterile or use birth control.
  • Have a life expectancy of at least 3 months.
  • Have recovered from previous treatments.

Exclusion Criteria

  • Have had previous treatment for metastatic head and neck cancer.
  • Have cancer that can be treated with local therapy.
  • Have a primary tumor in the nasopharynx.
  • Have had previous treatment with similar drugs.
  • Have had recent radiation therapy.
  • Have an autoimmune disease requiring treatment.
  • Have an immune deficiency or are on high-dose steroids.
  • Have had an organ transplant.
  • Have significant heart disease.
  • Have had a live vaccine recently.
  • Have an active infection needing treatment.
  • Have a history of lung inflammation.
  • Have other active cancers.
  • Have active HIV, hepatitis B, or hepatitis C infections.
  • Have untreated brain metastases.
  • Are participating in another clinical trial.
  • Are allergic to the study drugs.

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