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Trabectedin

Phase 2

Metastatic Adult Soft Tissue Sarcoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 8, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03590210Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue SarcomasPHASE2 COMPLETED 92 — — Jun 8, 2018Feb 12, 2022Nov 8, 20229 Germany
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Study Endpoints
Primary Endpoints
progression free survival rate at 6 months - PFSR6
after 6 months of treatment

The primary efficacy endpoint of the trial is the progression-free survival rate after 6 months (PFSR6), assessed by applying RECIST 1.1.

safety, as measured by: - Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths - Incidence of clinical laboratory test abnormalities
through study completion, an average of 24 months

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.

Secondary Endpoints
overall response rate (ORR)
through study completion, an average of 24 months
overall survival (OS)
through study completion, an average of 24 months
progression-free survival (PFS)
through study completion, an average of 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A - L-sarcomaEXPERIMENTALPatients 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-sarcomaEXPERIMENTALPatients 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
Interventions
NameTypeDescription
TrabectedinDRUGCycle 1 to 16 1.5mg/m² IV over 24 hours, q3w
NivolumabDRUGCycle 2 to 16 240 mg IV over 30 minutes, q3w
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:Germany
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