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Real-world data on keytruda and opdivo for HPV throat cancer could shape future trials

NCT ID NCT06771674

Knowledge-focused Sponsor: Hookipa Biotech GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at 662 patients with HPV-positive throat cancer that had spread or come back. Researchers wanted to see how patients were treated with pembrolizumab (Keytruda) or nivolumab (Opdivo), with or without chemotherapy, in real-world settings. The goal was to gather information on patient characteristics, treatment patterns, and outcomes to help design better clinical trials in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (Keytruda) and nivolumab (Opdivo), with or without chemotherapy
What this could lead to
If successful, this study could help design better future trials by comparing real-world outcomes with clinical trial data.
What could go wrong
This is an observational study, not a test of a new treatment. It only looks back at existing data, so it cannot prove what works best.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

662 people

The number who actually took part.

Started

Jun 2024

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms human papillomavirus-related squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck squamous cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oropharyngeal squamous cell carcinoma

Contacts and locations

Locations

  • Cardinal Health

    Dublin, Ohio, 43017, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.