Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

Conditions

• Metastatic Adult Soft Tissue Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas

Key Dates

Start date

Jun 8, 2018

Status verified

Nov 2022

Primary completion

Feb 12, 2022

Completion

Feb 12, 2022

Study Design

Enrollment

92 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A - L-sarcoma
  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
• Experimental: Group B - non-L-sarcoma
  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

Primary Outcome Measure

progression free survival rate at 6 months - PFSR6 [ Time Frame: after 6 months of treatment ]