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

Part of paid clinical trials in Dublin, Ohio.

Sponsor
Hookipa Biotech GmbH
Study ID
NCT06771674
Status
Completed

Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Given as monotherapy.
  • Nivolumab — DRUG
    Given in combination with chemotherapy.
  • Nivolumab — DRUG
    Given without chemotherapy.
  • Pembrolizumab — DRUG
    Given in combination with chemotherapy.
  • Pembrolizumab — DRUG
    Given without chemotherapy.

Study Details

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.

Key Dates

Start date
Jun 5, 2024
Status verified
Sep 2025
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
662 participants (actual)

Arms

  • Arm: ECA 1
    A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
  • Arm: ECA 3
    A representative sample of real-world patients with HPV+ R/M OPSCC and high CPS (at least 20 or more) treated with 1L pembrolizumab monotherapy.
  • Arm: ECA 2
    A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
  • Arm: ECA 4
    A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.

Primary Outcome Measure

Patient demographics with ECA 1 [ Time Frame: Whole study period (05 June 2024 through 30 April 2025) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cardinal HealthDublinOhio43017-

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By research site
Cardinal Health· Dublin, OH

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