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Experimental drug combo aims to fight returning head and neck tumors

NCT ID NCT03803774

Disease control Sponsor: National Cancer Institute (NCI) 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This early-phase trial tests a drug called birinapant together with a second course of targeted radiation for people whose head and neck cancer has come back in the same area. The drug works by blocking a protein that helps cancer cells survive. The main goals are to find the safest dose and to see what side effects occur. Only 13 people took part, so results are very preliminary.

What this could mean

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

Active substance
Birinapant (a drug that blocks a protein cancer cells need to survive)
What this could lead to
If it works, this could point toward a new treatment option for people whose head and neck cancer has come back after prior radiation.
What could go wrong
This is a very early (Phase 1) trial with only 13 people, so it is mainly about safety and dosing. The combination may cause serious side effects, and it is too soon to know if it will actually control the cancer.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * Patients must have histologically or cytologically confirmed locally recurrent HNSCC, including nasopharyngeal or sinonasal cancer for whom re-irradiation for local control is considered standard of care * Patients with human papillomavirus (HPV)-negative or HPV-positive head and neck cancer are eligible * Patients who have had prior treatment with immune therapies are eligible * Patients must have received curative-intent platinum- and/or cetuximab-based chemoradiotherapy or radiotherapy alone * Patients must have completed their last treatment dose with chemotherapy or immunotherapy at least 4 weeks (6 weeks for nitrosoureas or mitomycin C) before enrolling on study * Patients must have completed their last treatment dose with radiotherapy at least 6 months before enrolling on study * Patients who have had major surgery must be fully recovered and require a recovery period of at least 4 weeks prior to enrolling on study * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Hemoglobin \>= 9 g/dL (transfusion permitted) * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin within 1.5 x the upper limit of normal (ULN) institutional limits * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal * Serum creatinine =\< 1.5 x upper limit of normal (ULN), OR: Creatinine clearance \>= 50 mL/min according to Cockcroft Gault formula or other institutional methods * Patients must have a corrected QT interval by Fridericia (QTcF) =\< 480 msec * International normalized ratio (INR) =\< 1.5 and no clinically significant bleeding event within the past six months * Ability to understand and the willingness to sign a written informed consent document * Patients must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * The effects of birinapant on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) beginning at study entry and for the duration of study participation. Male study participants should use an additional barrier method of contraception for 30 days following the last dose of birinapant. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Eligibility for curative-intent surgery, unless the patient is considered a poor surgical candidate related to resectability, functional outcome, or prefers non-surgical therapy * More than 2 lines of palliative systemic therapy (platinum-, taxane- or cetuximab-based chemotherapy or immunotherapy) * Patients who are receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to birinapant * 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 birinapant may have 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 birinapant, breastfeeding should be discontinued prior to enrollment. A negative pregnancy test is required for women of childbearing potential. Women who are postmenopausal (age-related amenorrhea \>= 12 consecutive months, or who had undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing. If necessary, to confirm postmenopausal status, a follicle stimulating hormone (FSH) level may be included at screening * Human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with birinapant * Patients requiring the use of anti-tumor necrosis factor (anti TNF) therapies, such as infliximab, or patients who have received treatment with anti-TNF therapies within 5 half-lives of the drug (48 days for infliximab, 55 days for golimumab, 70 days for certolizumab and adalimumab, and 16 days for etanercept) * Patients with previous exposure to birinapant

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma nasopharyngeal squamous cell carcinoma non-keratinizing sinonasal squamous cell carcinoma

As listed by the trial registrant

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

Locally recurrent head and neck squamous cell carcinoma Nasopharyngeal squamous cell carcinoma Sinonasal squamous cell carcinoma

Contacts and locations

Locations

  • HaysMed

    Hays, Kansas, 67601, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607, United States

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Salina Regional Health Center

    Salina, Kansas, 67401, United States

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116, United States

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • Wake Forest Baptist Health - Wilkes Medical Center

    Wilkesboro, North Carolina, 28659, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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