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

NCT06771674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 662

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Cardinal Health

    collaborator INDUSTRY

  • Hookipa Biotech GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771674 on ClinicalTrials.gov