Clinical trialNCT05669664Active, not recruitingPhase 2Interventional

Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers

SponsorNational Cancer Institute (NCI)Enrollment21Locally Advanced Salivary Gland CarcinomaMetastatic Salivary Gland CarcinomaRecurrent Salivary Gland CarcinomaUnresectable Salivary Gland Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) or that has come back after a period of responding to prior therapy (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body. Giving darolutamide in combination with leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow or shrink them.

clinicaltrials.gov ↗

Investigators

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

Alan L Ho
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

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

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

United States

Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 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
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Uchealth University of Colorado Hospital
Aurora, Colorado, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Uc Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Uchicago Medicine Northwest Indiana
Crown Point, Indiana, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center at Nyu Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Ut Md Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute/university of Utah
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 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.

Darolutamide →Leuprolide →

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: 20 Jul 2023
Primary completion: 30 Nov 2026
Completion: 30 Nov 2026
Last update posted: 31 Jul 2026
Registered enrollment: 21
Registry id: NCT05669664

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.