Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants with PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Recurrent/Metastatic Head and Neck Carcinoma
- Registration Number
- JPRN-jRCT2031230371
- Lead Sponsor
- Ishibashi Hideyasu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method