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New combo therapy offers hope for head and neck cancer patients who Can't take standard chemo

NCT ID NCT04858269

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 14, 2026 · Updated 6 times

Summary

This phase 2 trial tests a weekly combination of two chemotherapy drugs (carboplatin and paclitaxel) plus the immunotherapy pembrolizumab in 31 patients with metastatic head and neck cancer who cannot receive the standard drug 5-fluorouracil. The goal is to see if this regimen shrinks tumors more effectively than pembrolizumab alone. Researchers are also tracking overall survival and side effects.

What this could mean

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

Active substance
Pembrolizumab, Carboplatin, Paclitaxel
What this could lead to
If successful, this weekly regimen could offer a more tolerable and effective first-line treatment option for patients with metastatic head/neck cancer who cannot use standard 5FU chemotherapy.
What could go wrong
This is a small phase 2 study with only 31 participants, so results may not apply broadly. The combination may cause side effects like low blood counts or immune-related reactions, and it may not improve survival compared to existing treatments.

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

31 people

The number who actually took part.

Started

May 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

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: * Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis. * Histologic or cytologic confirmation of malignancy by pathology report. * Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other). * 18 years old or greater. * ECOG performance status of 0-2. * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed. * Untreated, symptomatic central nervous system (CNS) metastases. * Active autoimmune disease requiring systemic immunosuppression. * History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for \>1 week). * History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatin or paclitaxel. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because paclitaxel and carboplatin are Class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Wake Forest Baptist Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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