Experimental drug combo for rare sarcoma shows promise, but trial halted early

NCT ID NCT05712694

Terminated Disease control Sponsor: Polaris Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding ADI-PEG 20 to standard chemotherapy (gemcitabine and docetaxel) could help people with advanced leiomyosarcoma, a rare soft tissue cancer. The study planned to enroll 218 participants whose cancer had progressed after prior treatment. Unfortunately, the trial was terminated early, so it is not yet known if the combination improves outcomes. The results may still provide clues for future research.

What this could mean

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

Active substance: ADI-PEG 20 (pegargiminase) plus gemcitabine and docetaxel
What this could lead to: If successful, this combination could offer a new treatment option for people with advanced leiomyosarcoma that has stopped responding to standard therapy.
What could go wrong: The trial was terminated early, so results are limited. It is unclear if ADI-PEG 20 adds benefit over chemotherapy alone, and side effects from the drug combination may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma sarcoma soft tissue sarcoma

As listed by the trial registrant

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

SOFT TISSUE SARCOMA

Contacts and locations

Locations

Chang Gung Medical Foundation Kaohsiung

Kaohsiung City, Niaosong District, 83301, Taiwan
Duke Cancer Institute

Durham, North Carolina, 27710, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Mass General Brigham Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States
McGill University Health Centre (Quebec)

Montreal, Quebec, H4A 311, Canada
Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
NYU Langone Health

New York, New York, 10016, United States
National Taiwan University Hospital

Taipei, Taipei, 10002, Taiwan
Northwestern

Chicago, Illinois, 60611, United States
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210, United States
Stanford University Medical Centre

Palo Alto, California, 94304, United States
Taipei Veterans General Hospital

Taipei, Taipei, 11217, Taiwan
UCLA

Santa Monica, California, 90404, United States
UCSF

San Francisco, California, 94158, United States
UHN - Princess Margaret Cancer Center (Ontario)

Toronto, Ontario, M5G 2M9, Canada
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
UPenn (Abramson Cancer Center, Pennsylvania Hospital)

Philadelphia, Pennsylvania, 19106, United States
USC Norris comprehensive cancer center

Los Angeles, California, 90033, United States
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of Colorado Cancer Center/ CU Anschutz Medical Campus

Aurora, Colorado, 80045, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Miami/ Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

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