Drug intelligence / Profile preview

ipilimumab + nivolumab + trabectedin

Development stage
Phase 2
Lead developer
Cancer Institute Medical Group
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

ipilimumab + nivolumab + trabectedin is an investigational combination therapy being evaluated for the treatment of advanced or metastatic soft tissue sarcoma (STS). This regimen, studied in the SAINT clinical trial (NCT03138161) led by the Sarcoma Oncology Research Center, LLC, combines two immune checkpoint inhibitors—ipilimumab (a monoclonal antibody targeting CTLA-4) and nivolumab (a monoclonal antibody targeting PD-1)—with trabectedin, a DNA-binding cytotoxic agent. Trabectedin is hypothesized to enhance the efficacy of the dual checkpoint blockade by inducing immunogenic cell death and modulating the tumor microenvironment, specifically by depleting immunosuppressive tumor-associated macrophages. In the Phase 2 portion of the SAINT trial, this triplet combination demonstrated significant clinical activity in previously untreated patients, showing a best response rate of 25.3% and a disease control rate of 87.3%.

Other names
SAINT regimenipilimumab + nivolumab + trabectedin
02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)DNAPDCD1 (Programmed cell death protein 1 receptor)

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