At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Pathologically confirmed locally advanced unresectable or metastatic soft tissue sarcoma
- ✓Previously treated patients enrolled in both Phase 1 and Phase 2
- ✓Measurable disease by RECIST v1.1
- ✕Untreated CNS metastases (treated metastases allowed if stable ≥2 weeks and on stable/decreasing corticosteroids ≤10 mg daily prednisone)
- ✕Carcinomatous meningitis
- ✕Pregnant or breast-feeding
- ✕History of or known or suspected autoimmune disease (with limited exceptions)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SAINT: A Phase 1/2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)
In Brief
A Phase 2 clinical trial evaluating Trabectedin, Ipilimumab, and 1 other intervention for Advanced Soft Tissue Sarcoma and Metastatic Soft Tissue Sarcoma. Currently recruiting, targeting 250 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Trabectedinis an alkylating drug indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
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.
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.