An observational study in Oropharyngeal Squamous Cell Carcinoma, sponsored by Hookipa Biotech GmbH. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Hookipa Biotech GmbH · Observational
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.
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.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 662 is above the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Hookipa Biotech GmbH is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Real-world patients with HPV+ R/M OPSCC who received 1L pembrolizumab monotherapy, or nivolumab with or without chemotherapy will be evaluated. The ECAs derived from this real-world study are matched to respective study populations from interventional clinical studies. Propensity score matching will be used to generate the ECAs. The baseline characteristics used for matching will encompass key demographic and clinical factors potentially associated with treatment outcomes and may include:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Drug: Pembrolizumab
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.
Drug: Pembrolizumab
A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Drug: Nivolumab · Drug: Pembrolizumab
A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Drug: Nivolumab · Drug: Pembrolizumab
Given as monotherapy.
Also known as: Keytruda
Given in combination with chemotherapy.
Also known as: Opdivo
Given without chemotherapy.
Also known as: Opdivo
Given in combination with chemotherapy.
Also known as: Keytruda
Given without chemotherapy.
Patient demographics with ECA 1
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 1
Clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 1
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 1
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA 2
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 2
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 2
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 2
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA3
Patient demographics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA3
Clinical characteristics among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA3
Treatment patterns among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA3
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC and with a CPS of at least 20 or more treated with 1L pembrolizumab monotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Patient demographics with ECA 4
Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Clinical characteristics with ECA 4
Describe the clinical characteristics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Treatment patterns with ECA 4
Treatment patterns among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
1L treatment outcomes with ECA 4
1L treatment outcomes among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with or without chemotherapy.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 1 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 1 real-world population with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy from this study.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 2 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 2 real-world population with HPV+ R/M OPSCC treated with pembrolizumab or nivolumab with chemotherapy from this study.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 3 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 3 real-world population with HPV+ R/M OPSCC and with CPS of at least 20 or more treated with pembrolizumab monotherapy from this study.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Real-world ECA 4 population versus a population from an interventional clinical study
Compare clinical outcomes of a matched patient population from an interventional clinical study with those of the representative ECA 4 real-world population with HPV+ R/M OPSCC treated with pembrolizumab or nivolumab with or without chemotherapy from this study.
Time frame: Whole study period (05 June 2024 through 30 April 2025)
Ran from Jun 2024 to primary completion in Feb 2025, 8 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hookipa Biotech GmbH