Clinical Trial 23376

• Overview

  Study Title:

  A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate he Efficacy And Safety of Petosemtamab Compared with Investigator's Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

  Objective:

  Primary * To compare antitumor activity in ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 as assessed by blinded independent central review (BICR) in patients with incurable metastatic / recurrent HNSCC patients progressed on after anti-PD-1 and platinum containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy * To compare OS in patients with incurable metastatic / recurrent HNSCC progressed on after anti-PD-1 and platinum-containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy Secondary * To evaluate antitumor activity in ORR per RECIST v1.1 as assessed by investigator review * To evaluate antitumor activity in DOR per RECIST v1.1 as assessed by BICR and investigator review * To evaluate antitumor activity in time to response (TTR) per RECIST v1.1 as assessed by BICR and investigator review * To evaluate antitumor activity in PFS per RECIST v1.1 as assessed by BICR and by investigator review * To evaluate antitumor activity in clinical benefit rate (CBR) per RECIST v1.1 as assessed by BICR and by investigator review * To evaluate safety and tolerability of petosemtamab monotherapy * To evaluate health-related quality of life (HRQL) using the European Organisation for Research and Treatment of Cancer (EORTC) validated Quality of Life of Cancer Patients Questionnaire (QLQ-C30) * To evaluate HRQL using the updated EORTC validated Quality of Life of Head and Neck Cancer Patients Questionnaire (QLQ-H&N43) * To characterize the pharmacokinetics (PK) of petosemtamab * To characterize the population PK of petosemtamab * To characterize the immunogenicity of petosemtamab

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  Cetuximab (); Erbitux (Cetuximab); Petosemtamab (); Taxotere (docetaxel); docetaxel (); methotrexate ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Signed ICF before initiation of any study procedures.
  • 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 0 or 1
  • Life expectancy ≥ 12 weeks, as per investigator
  • Adequate organ function (as per protocol)

• Exclusion Criteria

  Key Exclusion Criteria:
  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
  • Known leptomeningeal involvement
  • Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
  • Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
  • Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
  • History of hypersensitivity reaction to any of the excipients of treatment required for this study.
  • Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
  • History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
  • Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
  • Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
  • Patients with known infectious diseases (as per protocol)
  • Pregnant or breastfeeding patients
  • Patient has a primary tumor site of nasopharynx (any histology).

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