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New drug combo shows promise for Tough-to-Treat head and neck cancer

NCT ID NCT04313504

Disease control Sponsor: Trisha Wise-Draper 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, niraparib and dostarlimab, in 10 people with head and neck cancer that had come back or spread. The goal was to see if the combination could shrink tumors or slow the cancer. Participants had to be able to swallow pills and have no other curative options. The study is complete, and results help guide future research.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Nov 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options. * ECOG performance status ≤2 * Patients must be able to swallow pills Exclusion Criteria: * Nasopharyngeal and salivary gland tumors * Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia * Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab. * Patients with uncontrolled intercurrent illness. * Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

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

Head and neck cancer

Contacts and locations

Locations

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

More trials for these conditions

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