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A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
EU CTIS ID: 2023-503418-63-00
What this study is testing
To assess the antitumor activity of tislelizumab plus investigational agent(s)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects with histologically or cytologically confirmed recurrent or metastatic (R/M) HNSCC that is considered incurable by local therapies: a. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx; b. Subjects should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease is allowed.
- Subjects 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).
You likely can't join if
- Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma).
- Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucin domain containing-3 (TIM-3), LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- Any active malignancy ≤ 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast).
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases.
- A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United States
- Korea, Republic of
- Singapore
- United Kingdom
- Turkey
- Australia
- Taiwan
- China
- Georgia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; United States; Korea, Republic of; Singapore; United Kingdom; Turkey and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.