Vismodegib + Atezolizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of combining two drugs, vismodegib and atezolizumab (an immunotherapy drug), in treating certain ovarian cancers that resist standard treatments. These include ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based chemotherapy. Individuals whose cancer has progressed within six months after their last platinum-based treatment may qualify. This trial provides an opportunity to explore a new treatment approach when options are limited. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that combining vismodegib and atezolizumab holds promise for treating certain cancers. Atezolizumab boosts the immune system's ability to fight cancer and is generally well tolerated. Patients with advanced ovarian and uterine cancers have used it without new safety concerns, and most side effects were mild.
Vismodegib, the other drug in this combination, has been used in other treatments as well. This trial is in a phase that evaluates the treatment's effectiveness, indicating some prior understanding of its safety.
Both drugs in this trial have undergone previous safety studies. However, since individual responses vary, researchers will closely monitor participants to ensure their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of vismodegib and atezolizumab for ovarian cancer because it targets the disease in a novel way. Vismodegib works by inhibiting the Hedgehog signaling pathway, a process that is often activated in cancer cells, while atezolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This dual approach not only targets the cancer cells directly but also enhances the body's immune response against the tumor. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, this combination aims to specifically disrupt cancer growth and boost immune activity, potentially leading to more effective and less toxic treatment outcomes.
What evidence suggests that the combination of vismodegib and atezolizumab could be effective for ovarian cancer?
This trial will evaluate the combination of vismodegib and atezolizumab for treating ovarian cancer that resists standard platinum-based treatments. Research has shown that vismodegib, which blocks a pathway aiding tumor growth, combined with atezolizumab, an immunotherapy that boosts the immune system to fight cancer cells, might enhance treatment effectiveness. Studies suggest this combination could outperform each drug used alone. Early results appear promising, but further research is needed to confirm its efficacy.12367
Who Is on the Research Team?
Ronald Buckanovich, MD
Principal Investigator
UPMC Hillman Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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