Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor: University of Chicago + Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Maximally Tolerated Dose (MTD) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
Time frame: end of DLT evaluation period (first 28 days of treatment)
Recommended Phase II Dose (RP2D) of Zanzalintinib in Combination with Pembrolizumab and Cetuximab
Time frame: End of enrollment
Secondary Endpoints
Progression-Free Survival (PFS)
Overall Survival (OS)
Safety of zanzalintinib in combination with pembrolizumab and cetuximab
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), which is considered incurable by local therapies. * Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible. * Age: Participants must be at least 18 years old. * ECOG Performance Status: Must be 0-1. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing. * Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R/M disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) fr…
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