RecruitingPhase 1Phase 2NCT03138161

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

SAINT: A Phase 1/2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)

Sponsor

Sarcoma Oncology Research Center, LLC

Enrollment

250 participants

Start Date

Apr 13, 2017

Study Type

INTERVENTIONAL

Conditions

Metastatic Soft Tissue Sarcoma Advanced Soft Tissue Sarcoma

Summary

This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments — trabectedin (a chemotherapy drug), ipilimumab, and nivolumab (both immune checkpoint drugs) — for patients with advanced soft tissue sarcoma (a cancer of the body's connective tissues like muscle, fat, or tendons) that has already been treated. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with locally advanced or metastatic soft tissue sarcoma (confirmed by biopsy) - You have already received at least one prior treatment for your sarcoma - You are well enough to carry out daily activities **You may NOT be eligible if...** - You have not previously received any treatment for your sarcoma - Your cancer is a type of sarcoma excluded by the study - Your general health is too poor for this treatment combination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrabectedin

Trabectedinis an alkylating drug indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

DRUGIpilimumab

Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for (1) treatment of unresectable or metastatic melanoma, and (2) adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

DRUGNivolumab

A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-medicated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity.