Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer
A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer
Sponsor: University of Michigan Rogel Cancer Center + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Major pathologic response rate
Time frame: Up to 36 months
Secondary Endpoints
Neoadjuvant ivonescimab related toxicities
Overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Pathologic complete response rate
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age * PD-L1 combined positive score (CPS) \>= 1 * Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice * Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue * Eastern Cooperative Oncology Group (ECOG) 0-1 * Absolute neutrophil count \> 1500 cells/uL * Platelet count \>= 100,000/uL * Hemoglobin \>= 9.0 g/dL (without transfusion within 14 days prior to cycle 1, day 1) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 3 x ULN for participants with Gilbert's disease * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional ULN * Creatinine =\< 1.5 x institutional ULN OR estimated glomerular filtration rate (eGFR) value \>= 30/mL using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation OR measured (OR calculated) creatinine clearance \>= 50 mL/min u…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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