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Trabectedin · 1 trial · 1 indication
The primary efficacy endpoint of the trial is the progression-free survival rate after 6 months (PFSR6), assessed by applying RECIST 1.1.
The primary safety endpoint is to assess the feasibility of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas as determined by the safety and tolerability of the combination treatment.
| Arm | Type | Description |
|---|---|---|
| Group A - L-sarcoma | EXPERIMENTAL | Patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen will receive drug treatment with trabectedin (1 cycle mono-therapy) followed by trabectedin/nivolumab combination (up to 15 additional cycles); 16 cycles in total |
| Group B - non-L-sarcoma | EXPERIMENTAL | Patients with unresectable or metastatic soft tissue sarcoma other than liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen (GIST excluded) will receive drug treatment with trabectedin (1 cycle mono-therapy) followed by trabectedin/nivolumab combination (up to 15 additional cycles); 16 cycles in total |
| Name | Type | Description |
|---|---|---|
| Trabectedin | DRUG | Cycle 1 to 16 1.5mg/m² IV over 24 hours, q3w |
| Nivolumab | DRUG | Cycle 2 to 16 240 mg IV over 30 minutes, q3w |
Inclusion Criteria: Group A: 1 Patients must have histologically confirmed liposarcoma or leiomyosarcoma Group B: 1. Patients must have histologically confirmed soft tissue sarcoma (STS) other than liposarcoma or leiomyosarcoma (GIST excluded) Both Groups (A and B): 2. ≥ 1 prior systemic the...
Trabectedin is an investigational small molecule being studied for the treatment of Metastatic Adult Soft Tissue Sarcoma. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in combination with nivolumab in patients with this condition.
Trabectedin is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Metastatic Adult Soft Tissue Sarcoma.
Trabectedin is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial evaluating the drug has been completed, with results expected to inform further development.
Trabectedin has been studied in one completed Phase 2 clinical trial, identified as NCT03590210. This trial evaluated combined treatment with nivolumab and trabectedin in 92 patients with metastatic or inoperable soft tissue sarcomas in Germany.
Trabectedin is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here. The drug is being studied for its potential role in treating Metastatic Adult Soft Tissue Sarcoma.