Phase 2 Study of Vismodegib and Atezolizumab for Women with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are evaluating a new treatment combination for women with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who have shown disease progression within six months after platinum-based chemotherapy. Despite advances like PARP inhibitors, treatment response rates remain low in this setting, leading to poor prognosis and limited options. This Phase II trial explores the combination of vismodegib and atezolizumab as a potential approach to improve outcomes for these patients. Participants will receive vismodegib at a fixed dose of 150 mg taken orally once daily, alongside atezolizumab given at 1200 mg intravenously every three weeks, starting on Day 1 of each 21-day cycle. The combination aims to inhibit the hedgehog signaling pathway and block PD-L1 to potentially affect tumor growth and immune response. The study includes treatment until disease progression or unacceptable toxicity, with ongoing monitoring for safety and effectiveness. During the trial, participants will undergo regular assessments including imaging to evaluate tumor response, laboratory tests to monitor organ function and blood counts, and safety evaluations to detect any side effects. The primary outcomes include measuring dose-limiting toxicities within the first two weeks and objective response rates up to 36 months. Secondary outcomes assess immune-related responses, overall survival, and progression-free survival over the same period. Participants are expected to remain in the study for up to three years, with close follow-up throughout.

Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer