Phase II Study of Cemiplimab and ISA101b for Patients with Recurrent or Metastatic HPV16 Positive Oropharyngeal Cancer

Sponsor: ISA Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04398524

Provider View

This clinical trial is testing a combination of two drugs, ISA101b and cemiplimab, to see if they can improve treatment outcomes for patients with recurrent or metastatic HPV16 positive oropharyngeal cancer who have not responded to previous anti-PD-1 therapy.

Patient Parameters

Program Overview

This study aims to find out if the combination of ISA101b and cemiplimab can improve the response rate in patients with recurrent or metastatic HPV16 positive oropharyngeal cancer (OPC) who have previously been treated with anti-PD-1 therapy but did not respond well. Participants will receive both drugs and be monitored for their response to the treatment.

Description

This clinical trial is designed to evaluate the effectiveness of combining two drugs, ISA101b and cemiplimab, in treating patients with recurrent or metastatic HPV16 positive oropharyngeal cancer (OPC). The study focuses on patients who have already tried anti-PD-1 therapy, such as pembrolizumab or nivolumab, but their cancer continued to progress. The goal is to see if this new combination can improve the overall response rate to treatment. Participants will receive the study drugs and undergo regular assessments to monitor their cancer's response.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older.
  • Must provide signed informed consent.
  • Willing to attend study visits and follow procedures.
  • Diagnosed with recurrent or metastatic HPV16 positive oropharyngeal cancer (OPC).
  • Must have confirmed HPV16 positivity before joining the study.
  • Previously treated with a minimum dose of pembrolizumab or nivolumab for recurrent/metastatic HPV16 positive OPC.
  • Last anti-PD-1 treatment must have been within 6 months before starting the study.
  • Must have at least one measurable tumor by CT or MRI.
  • Must be in good general health with a performance status of 0 or 1.

Exclusion Criteria

  • Recent major surgery within 4 weeks before starting the study.
  • Received additional cancer treatments after anti-PD-1 therapy, except for certain palliative treatments.
  • Stopped immune therapies due to severe side effects.
  • Significant autoimmune disease requiring treatment in the past 5 years, except for certain conditions like vitiligo or controlled thyroid issues.
  • Untreated or active brain tumors or spinal cord issues.
  • Recent brain infections or uncontrolled seizures.
  • History of lung disease or non-infectious lung inflammation in the past 5 years, except for radiation-related lung issues.

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