Treatment for advanced sarcoma using a combination of chemotherapy and immunotherapy
GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second/Third Line Therapy for Advanced Sarcoma
This study is testing a new treatment combining chemotherapy and immunotherapy to see if it helps people with advanced sarcoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sarcoma Oncology Research Center, LLC Academic / other |
| Drugs / interventions | nivolumab, doxorubicin, immunotherapy |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT04535713 on ClinicalTrials.gov |
What this trial studies
This open label phase 2 study investigates the effectiveness of metronomic doses of gemcitabine, doxorubicin, and docetaxel combined with nivolumab immunotherapy in patients with advanced sarcoma. A total of 260 patients will receive these treatments intravenously, with specific dosing schedules outlined for each drug. The treatment cycles will occur every three weeks, and patients may continue therapy for up to one year unless significant disease progression or unacceptable toxicity occurs. The study aims to assess the safety and efficacy of this combination therapy in managing advanced sarcoma.
Who should consider this trial
Good fit: Ideal candidates include patients with locally advanced, unresectable, or metastatic sarcoma who have previously been treated and have measurable disease.
Not a fit: Patients with early-stage sarcoma or those who are not able to tolerate the treatment regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced sarcoma.
How similar studies have performed: Other studies have shown promise with similar combinations of chemotherapy and immunotherapy in treating various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Santa Monica, California
- Sant P Chawla — Santa Monica, California, United States (Recruiting)
Study contacts
- Principal investigator: Sant P Chawla, MD — Sarcoma Oncology Research Center, LLC
- Study coordinator: Sant P Chawla, MD
- Email: santchawla@sarcomaoncology.com
- Phone: 3105529999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.