A phase 3 study to evaluate petosemtamab vs. investigator's choice in previously treated metastatic / recurrent head and neck cancer.

INTERVENTION: Product Name: Methotrexate 25 mg/ml solution for injection, Product Code:PRD1888173, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: Erbitu X5 mg/mL solution for infusion, Product Code:PRD327539, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: Docetaxel EVER Valinject 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Product Code:PRD6727517, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: , Product Code:PRD5619269, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: CONDITION: patients with incurable, metastatic/recurrent 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 antitumor activity in ORR in patients with incurable metastatic / recurrent HNSCC patients treated with petosemtamab monotherapy vs investigator’s choice monotherapy; ; To compare OS in patients treated with petosemtamab monotherapy vs investigator’s choice monotherapy Primary end point(s): Objective response rate (ORR) as assessed by BICR., Overall survival (OS) Secondary Objective: To evaluate antitumor activity in ORR by investigator, To evaluate antitumor activity in DOR by investigator, To evaluate antitumor activity in time to response (TTR) as assessed by BICR and investigator review, To evaluate antitumor activity in PFS as assessed by BICR and by investigator review, To evaluate antitumor activity in clinical benefit rate (CBR) as assessed by BICR and by investigator review, To evaluate safety and tolerability of petosemtamab monotherapy SECONDARY OUTCOME: Secondary end point(s):Assess number of patients experiencing serious TEAEs Secondary end point(s):Assess number of patients experiencing treatment‐emergent adverse events (TEAEs) Secondary end point(s):CBR per RECIST v1.1 as assessed by BICR and by investigator review Secondary end point(s):DOR per RECIST v1.1 as assessed by BICR and by investigator review Secondary end point(s):Number of patients who discontinued study treatment due to TEAEs Secondary end point(s):Number of patients who had dose modifications due to TEAEs Secondary end point(s):ORR per RECIST v1.1 as assessed by investigator review Secondary end point(s):PFS per RECIST v1.1 as assessed by BICR and by investigator review Secondary end point(s):TTR per RECIST v1.1 as assessed by BICR and by investigator review INCLUSION CRITERIA: Willing and able to provide signed informed consent prior to initiation of any study procedures. Patients unable to provide their consent will not be eligible to participate in the study., Life expectancy = 12 weeks, as per investigator, Adequate organ function (as per protocol), Age = 18 years at signing of ICF, Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent., HNSCC patients progressed on or after anti‐PD‐1 therapy and platinum‐containing therapy., The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx., Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer., A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material, Measurable disease as defined by RECIST v1.1 by radiologic methods, ECOG PS of