NCT06771674Completed
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 662 (actual)
- First submitted
- 8 Jan 2025
- Start date
- 5 Jun 2024
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Hookipa Biotech GmbH
- Diseases
- Head and neck cancer
- NCT number
- NCT06771674
What you commit to
- Study type: Observational
- Participants enrolled: 662
- From 5 Jun 2024 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Central nervous system involvement or other concurrent malignancy at the time of 1L initiation.
Other
- Participation in a controlled clinical trial for 1L R/M OPSCC.
Who the study is looking for
- Confirmed diagnosis of HPV+ R/M OPSCC (base and posterior one-third of tongue, the tonsils, soft palate, and lateral pharyngeal walls).
- Initiated and treated with pembrolizumab monotherapy, or nivolumab (monotherapy or in combination with chemotherapy) as 1L therapy for HPV+ R/M OPSCC on or after 05 June 2024 (may have had curative intent treatment including surgery, chemotherapy, and/or radiotherapy for non-metastatic/non-recurrent disease).
- Have access to baseline assessment scan within 30 days prior to initiating 1L therapy for HPV+ R/M OPSCC and response assessment confirmed by objective measurements within 26 weeks of initiation of 1L therapy.
- Must have been followed for 6 months or more since initiation of 1L therapy for R/M OPSCC.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardinal Health Coordinator of this site? Confirm its status | Dublin | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.