A Phase 2, Randomized, Open-label, PlatformStudy Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants with Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Ishibashi Hideyasu0 个研究点目标入组 240 人开始时间: 2023年9月27日最近更新: 2024年4月1日

试验速览

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•Participants provide signed informed consentmust and are >-18 years of age at the time of signing the ICF.
•-Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies (the eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.).
•-Has measurable (target) disease based on RECIST 1.1.
•-Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•-Provides a tumor tissue sample obtained Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC.
•-Has tumor PD-L1 expression as determined by the DAKO 22C3 assay.
•-If the primary tumor site is oropharyngeal carcinoma, the participant must have HPV results using a p16 histology assay.
•-Has adequate organ function.
•-If of childbearing potential, female participants must be willing to use adequate contraception.

•-Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other immune checkpoint pathways.
•-Participants with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
•-Has had major surgery within 4 weeks of the first dose of study intervention.
•-Have active tumor bleeding or a high risk of bleeding.
•-Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC.
•-Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic CNS metastases.
•-Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years.
•-Has symptomatic ascites or pleural effusion.
•-History or evidence of cardiovascular risk.

发起方

Ishibashi Hideyasu