Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A person must sign a consent form agreeing to take part in the study
• The treating doctor must judge that the person is able to follow the study procedures
• A person must have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed through laboratory testing of tissue or cells
• The cancer must have grown or spread during or after treatment with platinum-based chemotherapy, within 6 months of finishing that treatment
• The cancer must be measurable or able to be assessed on scans, according to standard research criteria (confirm with trial site)
• For up to 12 participants, a stored tumour tissue sample must be available for research purposes
• A person must have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning they are fully active or restricted only in physically demanding activity)
• A person must be expected to live for at least 3 months
• Blood test results taken within 14 days before starting treatment must show the blood and organs are working well enough — including white blood cells, platelets, red blood cells, liver enzymes, kidney function, and protein levels all being within acceptable ranges (confirm specific values with trial site)
• A person must test negative for HIV at screening, or if HIV-positive, must be stable on HIV treatment with a healthy immune cell count and undetectable virus levels
• A person must test negative for hepatitis B at screening
• Women who could become pregnant must agree to use highly effective contraception (with a failure rate of less than 1% per year) during treatment and for 5 months after the last dose of atezolizumab and 24 months after the last dose of vismodegib, or remain completely abstinent during that time
• Women who could become pregnant must also agree not to donate eggs during the above period

Who may not be able to join:

• People who are unable or unwilling to swallow capsules
• People who are unable or unwilling to follow the study procedures
• People who have had cancer spread to the membranes surrounding the brain or spinal cord
• People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained once a month or more often (though people with a permanent drainage tube already in place may still be considered)
• People with uncontrolled or symptomatic high calcium levels in the blood
• People with a current or past autoimmune disease or immune deficiency (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions), with some exceptions — for example, people with thyroid conditions managed by hormone replacement, well-controlled type 1 diabetes on insulin, or mild skin conditions affecting less than 10% of the body that are well controlled with low-strength creams may still be considered (confirm with trial site)
• People with a history of certain lung conditions, including pulmonary fibrosis, drug-related lung inflammation, or organising pneumonia, or who show signs of active lung inflammation on a chest scan at screening
• People with active tuberculosis
• People who have had a significant heart or cardiovascular event (such as a heart attack or stroke) within the 3 months before starting treatment, or who have an unstable heart rhythm or unstable chest pain
• People who have had major surgery (other than for diagnosis) within 4 weeks before starting treatment, or who are expected to need major surgery during the study
• People who have had another cancer within the past 5 years, with some exceptions for cancers that carry very low risk of spreading or causing death (confirm with trial site)
• People who have had a serious infection, including a hospitalisation for infection, within 4 weeks before starting treatment
• People who have taken antibiotic treatment (not preventive antibiotics) within 2 weeks before starting treatment
• People who have previously had a bone marrow or organ transplant from another person
• People who have any other serious illness, abnormal test results, or medical condition that could make the study drugs unsafe or affect the study results
• People who have received a live vaccine within 4 weeks before starting treatment, or who are expected to need one during atezolizumab treatment or within 5 months of the last atezolizumab dose
• People currently taking antiviral medication for hepatitis B
• People who have taken another experimental treatment within 28 days before starting treatment
• People who have taken immune-stimulating medications (such as interferon or interleukin-2) within 4 weeks, or 5 half-lives of the drug — whichever is longer — before starting treatment
• People who have taken immune-suppressing medications (such as steroids or certain other drugs) within 2 weeks before starting treatment, or who are expected to need them during the study, with some exceptions for low-dose or short-course use (confirm with trial site)
• People who have had a severe allergic reaction to certain types of laboratory-made antibody-based medicines
• People with a known allergy to the ingredients in atezolizumab or to products made using Chinese hamster ovary cells
• People with a known allergy to the ingredients in vismodegib
• People who are pregnant or breastfeeding, or who plan to become pregnant during treatment or within 5 months of the last atezolizumab dose or 24 months of the last vismodegib dose
• Women who could become pregnant must have a negative blood pregnancy test within 14 days before starting treatment
• Participants must agree not to donate blood or blood products during the study and for 24 months after stopping vismodegib

Important: Always verify eligibility with the trial site directly before applying.