Study on PDT Induction Therapy for Head and Neck Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07214987

Provider View

This clinical trial is testing the safety and tolerability of a new treatment combination using toripalimab with cisplatin and docetaxel for patients with locally advanced head and neck cancer that is CPS-positive.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if a combination of toripalimab, cisplatin, and docetaxel (PDT) is safe and can be tolerated by patients with locally advanced head and neck cancer. Toripalimab is an antibody that helps the immune system attack cancer cells more effectively. This study will involve 26 participants who will receive the treatment for up to three cycles, unless their cancer progresses, they experience severe side effects, or they choose to leave the study. Participants will be monitored for two years. Toripalimab is not yet approved by the FDA for this specific type of cancer, but it is approved for other head and neck cancers. The study is supported by Coherus Biosciences, Inc., which provides the drug and funding for the research.

Description

This study is a Phase II trial to test the safety and effectiveness of a treatment combination called PDT, which includes toripalimab, cisplatin, and docetaxel. The study will start with 12 participants, and if at least 2 of them do not experience severe side effects, more participants will be enrolled until the study reaches 26 participants. Each participant will receive the treatment for three cycles or until their cancer worsens, they have unacceptable side effects, or they decide to stop participating. Participants will be followed for two years to monitor their health and the treatment's effects. Toripalimab is an antibody that helps the immune system target cancer cells, while cisplatin and docetaxel are chemotherapy drugs that kill cancer cells. This combination is being tested to see if it can be a new treatment option for head and neck cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a new diagnosis of squamous cell carcinoma in specific areas of the head and neck.
  • Cancer must be at stage III or non-metastatic stage IV, or stage II or III for HPV-associated oropharynx cancer.
  • Must be suitable for induction therapy due to tumor size, progression rate, symptoms, or potential benefits before local treatment.
  • CPS score of 1% or higher.
  • Age 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of more than 12 weeks.
  • Must have adequate blood and organ function based on specific medical tests.
  • Can have other cancers if they do not interfere with this study.
  • Must agree to use effective birth control during the study and for a specified time after.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Diagnosis of EBV-associated nasopharynx cancer.
  • Strong suspicion or confirmation of skin squamous cell carcinoma.
  • Cancer type other than squamous cell carcinoma.
  • Cancer that has spread below the collarbone.
  • Previous radiation to the head or neck, except for certain skin cancers.
  • Existing nerve damage of grade 2 or higher.
  • Currently receiving other experimental treatments for this condition.
  • Allergic reactions to similar drugs as those in the study.
  • Autoimmune condition requiring recent steroid treatment, except for long-term replacement therapy.
  • Another cancer needing treatment in the past 6 months.
  • Taking medications that affect certain liver enzymes.
  • Pregnant or breastfeeding women due to potential risks to the baby.

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