Study on ASP-1929 Photoimmunotherapy with Pembrolizumab for Recurrent Head and Neck Cancer Without Distant Spread

Sponsor: Rakuten Medical, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06699212

Provider View

This clinical trial is testing a new treatment combining ASP-1929 photoimmunotherapy with pembrolizumab to see if it can better treat recurrent squamous cell cancer of the head and neck that hasn't spread to other parts of the body. The study will compare this combination to standard treatments to see if it improves patient survival.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new treatment combining ASP-1929 photoimmunotherapy (PIT) with pembrolizumab can effectively treat recurrent squamous cell cancer of the head and neck that hasn't spread to distant parts of the body. Researchers will compare this new combination to standard treatments, which may include pembrolizumab alone or with chemotherapy, to see if it improves overall survival. The study will also assess the safety of the new treatment combination.

Description

This is a phase 3 study conducted at multiple centers to evaluate the effectiveness and safety of ASP-1929 photoimmunotherapy (PIT) combined with pembrolizumab, compared to standard treatments for recurrent head and neck squamous cell carcinoma (HNSCC) that hasn't spread to distant areas.

Participants will be randomly assigned to one of three groups: ASP-1929 PIT at two different doses combined with pembrolizumab, or a standard treatment group where they may receive pembrolizumab alone or with chemotherapy, based on the doctor's choice.

The study will start with a 2:2:1 randomization, meaning participants have a chance of being placed in either of the ASP-1929 PIT groups or the standard treatment group. An interim analysis will be conducted to help decide the best dose of ASP-1929 PIT, with input from the FDA.

The study aims to determine if the new treatment combination can improve survival rates compared to standard treatments, while also monitoring for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the head and neck, excluding nasopharynx or cutaneous squamous cell carcinoma.
  • Suitable for first-line treatment with pembrolizumab, with or without chemotherapy, for recurrent head and neck cancer.
  • No history of cancer spreading to distant parts of the body.
  • Tumors must have at least one lesion that can be treated with PIT and measured by scans.
  • Must not have received anti-PD-1 or anti-PD-L1 treatments before.
  • Combined positive score (CPS) of 1 or higher from an FDA-approved test.
  • Have results for HPV status if the cancer is in the oropharynx.
  • ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Adequate blood, kidney, and liver function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after the last treatment. Men must agree to use effective contraception during the study and for 120 days after the last treatment.

Exclusion Criteria

  • Diagnosed or treated for another cancer within the last 2 years, except for certain low-risk cancers.
  • History of severe reactions to cetuximab infusions.
  • Previous organ transplant.
  • Known or active cancer spread to the brain or spinal cord.
  • Life expectancy of less than 3 months.
  • Active autoimmune disease requiring treatment in the past 2 years, except for replacement therapies.
  • Evidence of lung disease or active non-infectious lung inflammation.
  • Active infection requiring treatment.
  • Known infections like tuberculosis, hepatitis B or C, or HIV.
  • Recent severe tumor bleeding.
  • Uncontrolled health conditions that could interfere with the study.
  • Recent chemotherapy, targeted therapy, or radiation therapy without recovery from side effects.
  • Recent treatment with monoclonal antibodies or investigational drugs.
  • Previous treatment with ASP-1929.
  • Use of high-dose steroids or immunosuppressive therapy recently.
  • Recent live vaccine.
  • Need for procedures involving significant light exposure soon after ASP-1929 PIT treatment.
  • Recent major surgery or injury, or need for major surgery during the study.

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