Actively Recruiting
Phase II Trial of Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Led by Ronald Buckanovich · Updated on 2025-11-26
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Ronald Buckanovich
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of vismodegib and atezolizumab in patients with platinum resistant ovarian, fallopian tube, or primary peritoneal cancer. This study focuses on patients whose disease progressed within six months after platinum-based chemotherapy, a group with limited treatment options and poor prognosis. The trial aims to explore new therapeutic candidates due to low response rates to existing single-agent therapies and the high mortality associated with advanced disease stages. Participants will receive a fixed daily dose of 150 mg vismodegib orally and 1200 mg of atezolizumab intravenously every three weeks in 21-day cycles. The combination targets the hedgehog signaling pathway and immune checkpoint PD-L1 to potentially improve treatment outcomes. The study includes a phase II clinical trial setting, with treatment and monitoring extending up to 36 months. During the trial, participants will undergo safety assessments focused on dose limiting toxicities and measurements of tumor response using standardized criteria over up to three years. Researchers will monitor overall survival and progression-free survival, along with immune-related response rates. Patients will provide tumor samples for biomarker research and complete laboratory tests to confirm eligibility and monitor health status throughout the study.
CONDITIONS
Brief Title
Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Ability to follow the study protocol as judged by the investigator
- Confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Disease progressed during or within 6 months after platinum-based chemotherapy
- Measurable or evaluable disease according to RECIST v1.1
- Availability of tumor tissue for biomarker research for some patients
- ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function within 14 days before treatment
- Negative HIV test or stable HIV on treatment with CD4 > 200 and undetectable viral load
- Negative hepatitis B surface antigen test
- For women who can become pregnant: agreement to abstain or use effective contraception during and after treatment for specified periods
You will not qualify if you...
- Unable or unwilling to swallow capsules or comply with study procedures
- History of leptomeningeal disease
- Uncontrolled pleural, pericardial effusion or ascites requiring frequent drainage
- Uncontrolled or symptomatic high calcium levels in the blood
- Active or history of autoimmune diseases or immune deficiencies, with some exceptions
- Lung diseases like idiopathic pulmonary fibrosis or active pneumonitis
- Active tuberculosis
- Significant heart disease within 3 months or unstable heart conditions
- Major surgery within 4 weeks before treatment or planned surgery during study
- Other recent cancers except low-risk types
- Severe infections or recent antibiotic treatments
- Previous stem cell or organ transplant
- Conditions that increase risk or affect study results
- Recent live vaccines
- Current antiviral therapy for hepatitis B
- Recent investigational or immunostimulatory treatments
- Recent systemic immunosuppressive medications with exceptions
- Severe allergic reactions to antibodies or study drug components
- Pregnancy or breastfeeding or intention to become pregnant during and after study
- Agreement not to donate blood during study and for 24 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive a combination of vismodegib daily and atezolizumab every 3 weeks as part of their cancer treatment.
Visits every 3 weeks for atezolizumab administration with additional monitoring as needed
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
K
Kelsey Mitch, BSN
L
Lucia Borasso, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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