Clinical trialNCT03803774Active, not recruitingPhase 1Interventional

Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

SponsorNational Cancer Institute (NCI)Enrollment13Locally Recurrent Head and Neck Squamous Cell CarcinomaNasopharyngeal Squamous Cell CarcinomaSinonasal Squamous Cell Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Vassiliki Saloura
National Cancer Institute LAO
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

33 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Los Angeles General Medical Center
Los Angeles, California, United States
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Um Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Um Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Um Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Moffitt Cancer Center - Mckinley Campus
Tampa, Florida, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
Haysmed
Hays, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
the University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
University of Kentucky/markey Cancer Center
Lexington, Kentucky, United States
Nci - Center for Cancer Research
Bethesda, Maryland, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee'S Summit
Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Nyu Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at Nyu Langone
New York, New York, United States
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Huntsman Cancer Institute/university of Utah
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Birinapant

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 25 Sept 2019
Primary completion: 15 Nov 2023
Completion: 9 Jul 2027
Last update posted: 3 Aug 2026
Registered enrollment: 13
Registry id: NCT03803774

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.