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:

• People aged 18 or older
• People who have been diagnosed with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by a pathology report, and whose cancer is of a specific type (high grade serous, endometrioid, or clear cell, or a mixed tumour where at least half is made up of these types)
• People whose cancer has come back at any point after platinum-based chemotherapy — whether that was within 30 days, between 31 and 180 days, or more than 181 days after the last dose
• People who have had any number of previous treatments or maintenance therapies for ovarian cancer
• People who have measurable disease on scans (per standard imaging criteria) and/or a raised CA-125 blood marker that meets standard criteria for evaluable disease
• People who are generally well enough to carry out light activity and care for themselves (rated 0 or 1 on a standard medical fitness scale)
• People whose recent blood test results (taken within 15 days before joining) meet the required levels for red blood cells, white blood cells, platelets, lymphocytes, and monocytes
• People whose recent blood test results (taken within 15 days before joining) show that their liver and kidney function are within the required ranges
• People of childbearing potential who have a negative pregnancy test taken within 7 days before joining
• People who are willing to sign a consent form agreeing to take part
• People who are willing to provide blood and tissue samples for research purposes, including stored tissue from a previous biopsy or surgery
• People who are willing to return to Mayo Clinic for follow-up visits during the active monitoring period
• People who are willing to receive a tetanus vaccination if they have not had one in the past 12 months
• People who are willing to have a temporary central line (a type of tube placed into a large vein) for a blood collection procedure called apheresis, if needed

Who may not be able to join:

• People who are pregnant, breastfeeding, or who are able to have children or father a child and are unwilling to use adequate contraception during the trial
• People who have previously been treated for ovarian cancer with a specific type of immunotherapy drug known as an anti-PD-1 or anti-PD-L1 monoclonal antibody
• People who have received intravenous anti-cancer treatment within 3 weeks before joining, or oral anti-cancer treatment within 1 week before joining
• People who are experiencing moderate or severe symptoms from their ovarian cancer, have tumours larger than 5 cm, or whose disease is likely to cause significant symptoms within the next 8 weeks (confirm with trial site)
• People with serious ongoing health conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with assessing the treatment
• People with uncontrolled HIV infection, or people with HIV who have a history of certain HIV-related conditions (Kaposi's sarcoma or multicentric Castleman disease); people with well-controlled HIV on stable treatment may still be considered (confirm with trial site)
• People with uncontrolled serious infections currently requiring treatment, a history of immune-related lung inflammation that required steroids, or an active autoimmune disease that required systemic treatment (other than simple hormone replacement) within the past 2 years
• People with certain active or uncontrolled hepatitis B or hepatitis C infections, unless specific treatment conditions have been met (confirm with trial site)
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements
• People who have another active cancer that required or is likely to require treatment, with some exceptions such as certain skin cancers, papillary thyroid cancer not needing treatment, or carcinoma-in-situ
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for serious heart rhythm problems
• People who have taken immune-suppressing medications above a low-dose threshold within 7 days before joining, or who are expected to need such medications during the trial (some exceptions apply — confirm with trial site)
• People who have had an allogeneic stem cell transplant (a transplant using donor stem cells)

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