NCT06771674

Real-world Study of First Line Pembrolizumab- or Nivolumab-treated HPV-positive Recurrent/Metastatic Oropharyngeal Squamous Cell Carcinoma

Real-world Study of Patients With Human Papillomavirus-positive Recurrent/ Metastatic Oropharyngeal Squamous Cell Carcinoma Treated With First Line Pembrolizumab or Nivolumab With or Without Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 662 (actual)
• Sponsor: Hookipa Biotech GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pembrolizumab and nivolumab (with or without chemotherapy) are used to treat head and neck cancer. The middle part of the throat (oropharynx) is a common location for head and neck cancer. This cancer is known as oropharyngeal squamous cell carcinoma (OPSCC) and is most often caused by human papillomavirus (HPV) infection. This real-world evidence study carried out in the United States (US) will assess patient demographic and clinical characteristics, treatment patterns, and effectiveness of pembrolizumab and nivolumab (with or without chemotherapy) in patients with HPV positive (HPV+) OPSCC after their cancer spread (metastatic) and/or returned (recurrent). The collected real-world data can be compared with data derived from matched study populations in clinical studies that test new therapies in patients with HPV+ OPSCC. This will allow a more reliable evaluation of the clinical benefits and better-informed design of future clinical studies in this patient population.

Detailed description

This non-interventional study will be conducted as a single-phase, multicenter medical chart review of US patients with HPV+ recurrent and/or metastatic (R/M) OPSCC treated with first-line (1L) pembrolizumab or nivolumab (with or without chemotherapy). Participating physicians (Cardinal Health's Oncology Provider Extended Network) and clinical sites (Practice Research Network) will be asked to submit data on patient demographics, clinical characteristics, treatment patterns, and 1L treatment outcomes during a 10-week data collection period. The networks do not overlap, eliminating the chance of duplicate patient records. The completion of data collection defines the study completion date. The data collection period will be followed by a data validation period based on responses of the participating physicians and clinical sites to follow-up questions. The data obtained in this study will create external control arms (ECAs) comprised of patients with HPV+ R/M OPSCC initiating 1L therapy with pembrolizumab monotherapy, or nivolumab with or without chemotherapy. The use of these ECAs will allow for a more accurate estimation of the effectiveness of therapies currently assessed in interventional clinical studies versus pembrolizumab or nivolumab (with or without chemotherapy) as assessed in this observational study in a non-randomized setting. This information will serve to increase the reliability of the study data from interventional clinical studies investigating therapies in matching indications and patient populations and improve the accuracy of the clinical data to inform future clinical trials.

Conditions

• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Given as monotherapy.
DRUG	Nivolumab	Given in combination with chemotherapy.
DRUG	Nivolumab	Given without chemotherapy.
DRUG	Pembrolizumab	Given in combination with chemotherapy.
DRUG	Pembrolizumab	Given without chemotherapy.

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-01-13
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States