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Soft Tissue SarcomaPhase 3NCT05712694

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

A Phase 3 study testing ADI PEG20 in people with Soft Tissue Sarcoma, run by Polaris Group at 30 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
ADI PEG20
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
30 sitesin 3 countries
Study dates
29 Nov 2023to 25 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for study participation if he/she meets the following criteria:
  • Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.
  • Determination of LMS subtype: uterine or non-uterine.
  • Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
  • Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
  • Treatment > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
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  • Age >18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of < 1 at enrollment (Appendix B).
  • Leukocytes ≥ 3,000/mcL.
  • Absolute neutrophil count ≥ 1,500/mcL.
  • Platelets ≥ 100,000/mcL.
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease)
  • AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
  • Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
  • Serum uric acid ≤ 8 mg/dL (with or without medication control).
  • QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women.
  • Subjects and their partners must be asked to use appropriate contraception. They must agree to use 2 forms of contraception or agree to refrain from intercourse for the duration of the study and for 35 days after the last dose of ADI-PEG 20 or for at least 3 months (male subjects) or 6 months (female subjects) after treatment with gemcitabine, whichever is the longer duration.
  • Ability to understand and willingness to sign the informed consent form.
  • No concurrent investigational drug studies are allowed.

Who cannot join

  • A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
  • Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of current diagnosis.
  • Currently receiving chemotherapy, immunotherapy, interferon, radiation therapy or other investigational agents. Note: Chemotherapy agent washout period is 5 half-lives prior to randomization. Radiation washout period is 7 days prior to randomization.
  • Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
  • Prior pelvic radiation.
  • Known brain metastases. Such patients must be excluded from this 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.
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated compounds, or other agents used in this study.
  • 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.
  • History of seizure disorder not related to underlying cancer.
  • Grade 2 or higher neuropathy.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity. Because of the potential for pharmacokinetic interactions of antiretroviral therapy with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Currently receiving other immunosuppressive agents.
  • Subjects under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision

Trial locations and contacts

30 sites in 3 countries.

30 sites in 3 countries

United States25 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado Cancer Center/ CU Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Mass General Brigham Cancer Center

    Boston, Massachusetts, 02114

  • Northwestern

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • USC Norris comprehensive cancer center

    Los Angeles, California, 90033

  • University of Miami/ Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Medical College of Wisconsin/ Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • NYU Langone Health

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stanford University Medical Centre

    Palo Alto, California, 94304

  • UPenn (Abramson Cancer Center, Pennsylvania Hospital)

    Philadelphia, Pennsylvania, 19106

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UCSF

    San Francisco, California, 94158

  • UCLA

    Santa Monica, California, 90404

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Taiwan3 sites

  • Chang Gung Medical Foundation Kaohsiung

    Kaohsiung City, Niaosong District, 83301

  • National Taiwan University Hospital

    Taipei, Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217

Other trials in Taiwan

Canada2 sites

  • McGill University Health Centre (Quebec)

    Montreal, Quebec, H4A 311

  • UHN - Princess Margaret Cancer Center (Ontario)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Read the detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Being tested
ADI PEG20, Placebo
Keywords
Soft Tissue Sarcoma, Arginine, Arginine Deiminase, ADI-PEG 20, Pegargiminase, Leiomyosarcoma
Medical subject headings
Sarcoma, Leiomyosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADI PEG20Drug

    Also called Pegargiminase

    Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

  • PlaceboOther

    Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

Study groups in NCT05712694
Study groupRoleWhat they receive
ADIGemDocExperimentalADI-PEG 20: 36 mg/m2 on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 600 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 60 mg/m2 on day 8 of each 21-day cycle
Receives: Drug: ADI PEG20
PBOGemDocPlacebo comparatorPlacebo: matched PBO on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 900 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 75 mg/m2 on day 8 of each 21-day cycle
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary End Point of PFS

    The primary objective is to compare the primary endpoint of PFS in subjects treated with the arginine degrading enzyme ADI-PEG 20 plus Gem and Doc (ADIGemDoc) or PBO plus Gem and Doc (PBOGemDoc) in the 2nd or 3rd line setting using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review committee (BICR)

    Measured: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

Secondary outcomes (3)

  1. Secondary End Point of ORR (CR+PR)

    The secondary objectives are to compare ADIGemDoc versus PBOGemDoc with respect to:

    Objective response rate (ORR) (complete response [CR] + partial response [PR]) The secondary endpoint of ORR will be assessed by BICR using RECIST 1.1 and tested using a CMH test stratified by the stratification factors used during the randomization based on the ITT population.

    Measured: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

  2. Secondary End Point of Overall Survival (OS)

    The secondary objectives are to compare ADIGemDoc versus PBOGemDoc with respect to:

    OS

    The secondary endpoint of OS will be tested using a log-rank test stratified by the stratification factors used during the randomization based on the ITT population. A stratified Cox model will be used to estimate HR and 95% CI, and KM curves will be used to estimate OS median and 95% CI.

    Measured: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

  3. Secondary End Point of Safety and Tolerability

    All clinically significant abnormalities and deteriorations will be followed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE V5).

    Measured: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2023
  2. Study start29 Nov 2023
  3. Primary completion25 May 2026
  4. Study completion25 May 2026

Why it stopped: Lack of Efficacy, no safety concern.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05712694
Sponsor's protocol ID
POLARIS2022-001
Status last verified
Jun 2026
First submitted
13 Dec 2022
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADI PEG20 in people with Soft Tissue Sarcoma, run by Polaris Group at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Taiwan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Efficacy, no safety concern.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary End Point of PFS (time frame: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05712694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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