Gold Coast Private Hospital | Clinical Trials Centre
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About
This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Full description
This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience.
Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals.
The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.
Enrollment
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Inclusion criteria
Participants with histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies
Participants must have positive PD-L1 expression (Combined Positive Score [CPS] ≥ 1)
Have at least 1 measurable lesion as defined per RECIST v1.1
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Adequate hematologic and organ function as indicated by specific laboratory values within 7 days of first dose of study drug
Willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
Exclusion criteria
Note: Other inclusion and exclusion criteria may apply
Primary purpose
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Interventional model
Masking
160 participants in 4 patient groups
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Central trial contact
Study Director
Data sourced from clinicaltrials.gov
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