A phase 3 study to evaluate petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of head and neck cancer

INTERVENTION: Product Name: , Product Code:PRD5619269, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: PEMBROLIZUMAB, Product Code:SUB167136, Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR INJECTION, Other descriptive name: humanized monoclonal anti‐programmed cell death‐1 (PD‐1) antibody , Strength: CONDITION: First‐line treatment of recurrent or metastatic PD‐L1+ head and neck squamous cell carcinoma. ; MedDRA version: 22.0Level: LLTClassification code: 10082179Term: Squamous cell carcinoma of head and neck metastatic Class: 10029104 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective: To compare OS in the 1L setting of incurable metastatic/recurrent HNSCC patients eligible for pembrolizumab monotherapy with tumors expressing PDL1 (combined positive score [CPS]=1) without previous anti PD‐(L)1 and EGFR therapies, treated with petosemtamab in combination with pembrolizumab.; To compare ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 in the 1L setting of incurable metastatic/recurrent HNSCC patients eligible for pembrolizumab monotherapy with tumors expressing PDL1 (CPS=1) without previous anti PD‐(L)1 and EGFR therapies, treated with petosemtamab in combination with pembrolizumab. Primary end point(s): 1. Objective response rate (ORR), 2. Overall survival (OS) Secondary Objective: 1. To evaluate antitumor activity in PFS per RECIST v1.1, 2. To evaluate antitumor activity in DOR per RECIST v1.1, 3. To evaluate antitumor activity in clinical benefit rate (CBR) per RECIST v1.1, 4. To evaluate antitumor activity in percentage of patients with PFS per RECIST v1.1 SECONDARY OUTCOME: Secondary end point(s):1. PFS per RECIST v1.1 as assessed by investigator review Secondary end point(s):2. The Duration of Response (DoR) per RECIST v1.1 and by investigator review Secondary end point(s):3. The Clinical Benefit Rate (CBR) per RECIST v1.1 and by investigator review Secondary end point(s):4. The percentage of patients with PFS per RECIST v1.1 and by investigator review INCLUSION CRITERIA: 1. Signed ICF before initiation of any study specific procedures, 10. Left ventricular ejection fraction (LVEF) =50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, 11. Adequate organ function (as per protocol), 12. Known human immunodeficiency virus (HIV) status. HIV‐positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is = 300/µL, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy (HAART), 2. Age = 18 years at signing of ICF, 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. Patients with HNSCC primary tumor locations in oropharynx, oral cavity, hypopharynx, and laryn Xare eligible., 4. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD L1, CPS =1, as determined by an IHC test in a central laboratory, 5. HNSCC patients should not ha