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

NCT06771674 | Completed

• 1 other identifier: H-RWE-001
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oropharyngeal squamous cell carcinoma; throat; head and neck cancer; squamous cell cancer; OPSCC; HNSCC; human papillomavirus; HPV; immunotherapy; real-world study; PD-L1 therapy; checkpoint inhibitor; pembrolizumab; nivolumab

Outcome Measures

Primary Outcomes (16)

• Patient demographics with ECA 1

  Patient demographics among real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Whole study period (05 June 2024 through 30 April 2025)

Secondary Outcomes (4)

• Real-world ECA 1 population versus a population from an interventional clinical study

  Whole study period (05 June 2024 through 30 April 2025)

• Real-world ECA 2 population versus a population from an interventional clinical study

  Whole study period (05 June 2024 through 30 April 2025)

• Real-world ECA 3 population versus a population from an interventional clinical study

  Whole study period (05 June 2024 through 30 April 2025)

• Real-world ECA 4 population versus a population from an interventional clinical study

  Whole study period (05 June 2024 through 30 April 2025)

Study Arms (4)

ECA 1

A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab monotherapy.

Drug: Pembrolizumab

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.

Drug: Pembrolizumab

ECA 2

A representative sample of real-world patients with HPV+ R/M OPSCC treated with 1L pembrolizumab or nivolumab with chemotherapy.

Drug: Nivolumab; Drug: Pembrolizumab

ECA 4

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

Interventions

Pembrolizumab DRUG

Given as monotherapy.

Also known as: Keytruda

ECA 1; ECA 3

Nivolumab DRUG

Given in combination with chemotherapy.

Also known as: Opdivo

ECA 2; ECA 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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: * Type of disease (only recurrent/metastatic including any recurrent) * Smoking history * Sex at birth * Race/Ethnicity * Hemoglobin

You may qualify if:

• 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.

You may not qualify if:

• Participation in a controlled clinical trial for 1L R/M OPSCC.
• Central nervous system involvement or other concurrent malignancy at the time of 1L initiation.

Sponsors & Collaborators

• Hookipa Biotech GmbH: lead
• Cardinal Health: collaborator

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Neoplasms, Squamous Cell

Interventions

pembrolizumab; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: June 5, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)