Recruiting
Phase 2

Metronomic Gemcitabine, Doxorubicin, Docetaxel, Nivolumab

Sponsor:

Sarcoma Oncology Research Center, LLC

Code:

NCT04535713

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Doxorubicin

Docetaxel

Nivolumab

Study Details

Brief summary:

This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.

Conditions

Sarcoma

Study ID

NCT04535713

Start date

Sep 30, 2020

Status verified date

Jul, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma
  • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Previously treated patient with measurable disease by RECIST v1.1
  • ECOG performance status ≤ 2
  • Life expectancy of at least 3 months
  • Acceptable cardiac function with LV ejection fraction of > 50%
  • Acceptable liver function: Bilirubin < 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos < 2.5 x ULN (< 5 x ULN if liver metastases present)
  • Acceptable renal function: Creatinine < 1.5 times ULN and creatinine clearance > 60 ml/min using the Crockroft-Gault formula
  • Acceptable hematologic status: ANC >1000 cells/μL; Platelet count >100,000/μL; Hemoglobin > 9.0 g/dL
  • INR and PT < 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants
  • All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.

Exclusion Criteria:

  • History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Currently receiving treatment with another investigational device or drug study, or <14 days since ending treatment with another investigational device or drug study(s).
  • Subject has known sensitivity to gemcitabine, doxorubicin, docetaxel or nivolumab.
  • Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.
  • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.
  • Sexually active subjects and their partners unwilling to use male or female latex condom

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single arm

A total of 260 patients will receive gemcitabine 600 mg/m2 (maximum dose: 1000 mg) on D1 and D8, doxorubicin 18 mg/m2 on D1 and D8 (maximum dose: 32 mg), docetaxel 25 mg/m2 on D1 and D8 (maximum dose: 42 mg), on Days 1 and 8. After the first cycle, nivolumab 240 mg IV will be added on Day 1 of each cycle (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.

Interventions

Gemcitabine

600 mg/m2 (Maximum Dose: 1000 mg) i.v. on Day 1 and Day 8 of Cycle 1+

Doxorubicin

18 mg/m2 (Maximum Dose: 32 mg) i.v. on Day 1 and Day 8 of Cycle 1+

Docetaxel

25 mg/m2 (Maximum Dose: 42 mg) i.v. on Day 1 and Day 8 of Cycle 1+

Nivolumab

240 mg i.v. on Day 1 beginnning Cycle 2+

Primary outcome measure

  • Progression free survival [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sant P Chawla, MD

3105529999santchawla@sarcomaoncology.com

Victoria Chua-Alcala

3105529999vchua@sarcomaoncology.com

Locations

Sant P Chawla

Recruiting

Santa Monica, California, United States, 90403

Contacts

Sant P Chawla, MD

310-552-9999santchawla@sarcomaoncology.com

Victoria Chua-Alcala, MD

3105529999vchua@sarcomaoncology.com

More Information

Sponsor

Sarcoma Oncology Research Center, LLC

Last update posted

Jul 5, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sarcoma Oncology Research Center, LLC on 2024-07-05.