Actively Recruiting
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
513 weeks
Total Duration
On this page
Sponsors
R
Ronald Buckanovich
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 comply with the study protocol
- Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Disease progression during or within 6 months after platinum-based chemotherapy
- Measurable or evaluable disease per RECIST v1.1
- Availability of tumor specimen for biomarker research (for 12 patients)
- ECOG Performance Status of 0-1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function based on specified lab tests within 14 days prior to treatment
- Negative HIV test or stable on anti-retroviral therapy with CD4 count > 200 and undetectable viral load
- Negative hepatitis B surface antigen test
- For women of childbearing potential, agreement to abstain from heterosexual intercourse or use effective contraception during treatment and specified periods after
- Willingness to refrain from egg donation during treatment and specified post-treatment periods
You will not qualify if you...
- Inability or unwillingness to swallow capsules or comply with study procedures
- History of leptomeningeal disease
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage (monthly or more)
- Active or symptomatic hypercalcemia
- Active or history of autoimmune disease or immune deficiency, except certain controlled conditions
- History of specific lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease within 3 months prior to treatment
- Major surgery within 4 weeks prior to treatment or planned during the study
- History of other malignancy within 5 years except certain low-risk cancers
- Severe infection within 4 weeks prior to treatment
- Recent therapeutic antibiotics use within 2 weeks prior to treatment
- Prior allogeneic stem cell or solid organ transplant
- Any condition that contraindicates investigational drug use or increases risk
- Recent live attenuated vaccine use or planned use during or shortly after treatment
- Current antiviral therapy for hepatitis B
- Recent investigational therapy use within 28 days prior to treatment
- Recent systemic immunostimulatory or immunosuppressive therapy within specified time frames
- History of severe allergic reactions to antibodies or formulation components
- Known allergies to study drug components
- Agreement not to donate blood during and after treatment
- Pregnancy, breastfeeding, or intention to become pregnant during treatment and specified post-treatment periods
- Women of childbearing potential must have a negative pregnancy test within 14 days prior to treatment initiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
K
Kelsey Mitch, BSN
CONTACT
L
Lucia Borasso, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here