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NOT YET RECRUITING
NCT07824986
PHASE3

A Phase 3 Trial in Advanced Epithelioid Mesothelioma

Sponsor: Vivace Therapeutics, Inc

View on ClinicalTrials.gov

Summary

This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.

Official title: A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2026-12-01

Completion Date

2031-01-01

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DRUG

VT3989

• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle

DRUG

gemcitabine

• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

DRUG

Vinorelbine

• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice