Study on Tislelizumab with Other Investigational Drugs for Head and Neck Cancer

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05909904

Provider View

This clinical trial is testing the effectiveness and safety of the drug tislelizumab, alone and in combination with other investigational drugs, for treating head and neck squamous cell carcinoma that has returned or spread.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug tislelizumab, used alone or with other investigational drugs, can improve treatment outcomes for people with head and neck squamous cell carcinoma that has come back or spread. Researchers want to find out how many participants show no signs of cancer or have improvements in their cancer symptoms after treatment, and what side effects they might experience. Tislelizumab works by helping the immune system's T-cells better attack cancer cells. The study will include about 160 participants who will be randomly assigned to different treatment groups. The treatments will be given through a vein at regular intervals and will continue until they are no longer effective, cause too many side effects, or the participant decides to stop.

Description

This study is exploring whether the drug tislelizumab, alone or combined with other investigational drugs, can help treat head and neck squamous cell carcinoma. The main goals are to see how many participants have no evidence of cancer or show improvement in cancer symptoms after treatment, and to identify any side effects they might experience.

Tislelizumab helps the immune system's T-cells find and attack cancer cells by blocking a specific pathway. It may be used with other therapies to potentially improve treatment outcomes for cancer patients. The study will involve about 160 participants who will be randomly assigned to different treatment groups. Tislelizumab and other investigational drugs will be given as an infusion through a vein at scheduled times.

The study will take place at multiple locations worldwide. Participants will continue treatment until it is no longer beneficial, causes too many side effects, or they choose to stop.

Eligibility Criteria

Inclusion Criteria

  • Have head and neck squamous cell carcinoma that cannot be cured with local treatments.
    • The cancer must be located in the oropharynx, oral cavity, hypopharynx, or larynx.
    • No previous systemic therapy for recurrent or metastatic cancer, except if given as part of treatment for advanced disease.
  • Must have a positive PD-L1 expression score of 1 or higher.
  • Have at least one measurable tumor.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate blood and organ function based on lab tests within 7 days before starting the study drug.
  • Agree to use effective birth control during the study and for at least 120 days after the last dose.

Exclusion Criteria

  • Have cancer of the nasopharynx, unknown primary, skin, or salivary gland, or non-squamous cell types.
  • Have had previous treatment with certain immune-targeting drugs.
  • Have another active cancer within 2 years before joining the study, except for specific low-risk cancers.
  • Have a history of lung diseases like interstitial lung disease or uncontrolled lung conditions.
  • Have had severe allergic reactions to monoclonal antibodies or severe immune-related side effects from previous immunotherapy.

Note: Other criteria may apply.

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