Phase 2 Ovarian Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Women aged 18 or older who have been diagnosed with a specific type of ovarian cancer called high-grade non-mucinous epithelial ovarian cancer, confirmed by laboratory tissue analysis.
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 120 days after the last dose of study medication.
• People who have given written consent to participate in the trial.
• People who are considered generally well enough to carry out daily activities with little to no limitation, as measured by a standard medical scale (called ECOG performance status 0 or 1), assessed within 7 days before the first dose.
• People who have already completed standard first-line treatment, meaning at least six cycles of platinum and taxane chemotherapy (with or without bevacizumab), including those who received chemotherapy before surgery, and who now show minimal remaining signs of disease — for example, normal CA-125 levels and no obvious disease on scans.
• People who show evidence of minimal remaining disease, defined as either a second-look surgery finding positive cancer tissue or cells within 3 months of finishing chemotherapy, OR a positive result on a specific blood test called the Signatera ctDNA assay within the same timeframe.
• People who had a second-look surgery and whose tissue or cell samples confirmed remaining ovarian cancer — including cases where cancer cells were found in fluid samples even if tissue biopsies were negative.
• People who are willing to allow the trial to use stored tissue samples from their primary surgery and, if performed, their second-look surgery.
• People whose blood test results show that their major organs (such as kidneys, liver, and bone marrow) are functioning at a minimum required level as specified by the trial.
• People who have recovered sufficiently from second-look surgery to begin the trial treatment no earlier than 28 days and no later than 7 weeks after that surgery.
• Women with a negative pregnancy blood test within 72 hours before the first dose, unless they have had surgery making pregnancy impossible or have been post-menopausal for more than one year.

Who may not be able to join:

• People who have previously received certain types of immunotherapy drugs that target specific immune system pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents).
• People who have received radiation therapy within 2 weeks before starting the trial, or who have not fully recovered from radiation side effects, or who have developed a lung condition from radiation.
• People who have received a live or live-attenuated vaccine (such as certain flu or shingles vaccines) within 30 days before the first dose.
• People who are currently participating in another clinical trial or have received another experimental treatment within 4 weeks before starting this trial.
• People who have a weakened immune system, or who are regularly taking steroid medications above a certain dose, or who have used immune-suppressing drugs within 7 days before the first dose.
• People who have another active or recently treated cancer within the past 3 years, with some exceptions for certain skin cancers or non-invasive cancers that have been successfully treated.
• People who have active cancer spread to the brain or the lining of the brain, unless the brain metastases were previously treated, have been stable for at least 4 weeks on imaging, and have not required steroids for at least 14 days.
• People who have an autoimmune disease that has required systemic medical treatment within the past 2 years (note: simple hormone or enzyme replacement therapy is not counted as systemic treatment).
• People who have a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People with a serious active infection that the treating doctor believes would make participation unsafe.
• People with uncontrolled HIV infection (those with a normal immune cell count and undetectable virus levels may still be considered eligible).
• People with active, uncured Hepatitis B or Hepatitis C infection.
• People with any other medical condition, therapy, or abnormal test result that the treating doctor believes could interfere with the study or would not be in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 120 days after the last dose.
• People who have received an organ or tissue transplant from another person.
• People with persistently high blood pressure (above 150 systolic or 90 diastolic) in the 30 days before starting treatment, unless it has been brought under control with appropriate medication.
• People whose ovarian cancer is of the mucinous or low-grade epithelial type.
• People whose cancer has a known harmful BRCA gene mutation (in either tumour or inherited genes), or whose tumour has tested positive for a condition called homologous recombination deficiency (HRD).
• People with a history of arterial blood clots (note: blood clots in the lungs' smaller vessels or a history of deep vein thrombosis with appropriate treatment may still be considered eligible — confirm with trial site).
• People with a history of abnormal connections between the gut or urinary tract and other structures (fistulae), non-healing wounds, or other conditions that the investigator believes would make the bevacizumab component of treatment too risky.
• People who are unable or unwilling to understand and follow the study instructions, or who have a history of not following medical instructions.
• People who are receiving or planning to receive any other cancer treatment at the same time, including chemotherapy, biological therapy, radiation, or live cancer vaccines.
• People with any other medical condition that the investigator believes would significantly increase the risks of participating in this trial.

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