Vismodegib + Atezolizumab for Ovarian Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic immunosuppressive medications and systemic immunostimulatory agents must be stopped before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Vismodegib and Atezolizumab for ovarian cancer?
Is the combination of Vismodegib and Atezolizumab safe for humans?
Vismodegib has been approved for use in basal cell carcinoma and is generally considered safe, but it can cause side effects like muscle spasms, hair loss, and nausea. It is also known to cause birth defects, so it should not be used during pregnancy. Atezolizumab, used in other cancers, has its own safety profile, but specific safety data for the combination with Vismodegib in ovarian cancer is not provided.678910
How is the drug combination of Vismodegib and Atezolizumab unique for treating ovarian cancer?
The combination of Vismodegib and Atezolizumab is unique because it targets both the Hedgehog signaling pathway (through Vismodegib) and the immune checkpoint pathway (through Atezolizumab), potentially offering a novel approach to enhance the body's immune response against ovarian cancer, which has limited treatment options beyond traditional chemotherapy.123411
What is the purpose of this trial?
This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.
Research Team
Ronald Buckanovich, MD
Principal Investigator
UPMC Hillman Cancer Center
Eligibility Criteria
This trial is for adults with ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants need good organ function and blood work within normal ranges, no severe infections or heart issues recently, not on certain medications, and must agree to contraception if applicable. They should have a life expectancy of at least 3 months and an ECOG Performance Status of 0-1.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of vismodegib and atezolizumab. Vismodegib is administered at a fixed dose of 150 mg PO daily, and Atezolizumab is administered at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of objective response rate, progression-free survival, and overall survival.
Treatment Details
Interventions
- Atezolizumab
- Vismodegib
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
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Who Is Running the Clinical Trial?
Ronald Buckanovich
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD