Study on ONC-392 and Pembrolizumab for Treating Platinum-Resistant Ovarian Cancer

Inclusion Criteria

• Women aged 18 or older who agree to participate and provide written consent.
• Diagnosed with high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Have had previous surgery, including removal of the uterus and ovaries.
• Cancer must be resistant to platinum-based chemotherapy:
  • If only one line of therapy was received, cancer must have progressed 3 to 6 months after the last platinum dose.
  • If two or more lines of platinum therapy were received, cancer must have progressed within 6 months after the last platinum dose.
• Must have received at least one prior anti-cancer treatment, with or without bevacizumab or a PARP inhibitor, and be suitable for single-agent therapy as the next treatment.
• Must have at least one measurable tumor that can be tracked using scans.
• Must be in good overall health with an ECOG score of 0 or 1.
• Must have completed previous cancer treatments within specified timeframes before starting the study.
• Must have a life expectancy of at least 12 weeks and be well enough to receive experimental therapy.
• Must have adequate organ function as determined by specific blood tests.

Exclusion Criteria

• Have certain types of ovarian cancer, such as carcinosarcoma or clear cell carcinoma.
• Have cancer that did not respond to first-line platinum chemotherapy or progressed within 3 months of the last dose.
• Have a high risk of disease progression, such as needing fluid drainage from the abdomen within 14 days before treatment.
• Have active brain metastases unless treated and stable without steroids for at least 7 days before treatment.
• Are on high-dose steroid therapy for autoimmune conditions.
• Have another active cancer requiring treatment within the past 24 months.
• Have a history of serious heart or blood vessel problems within 12 months before treatment.
• Have an active infection requiring IV antibiotics or hospitalization within 14 days before treatment.
• Have not recovered from side effects of previous cancer treatments.
• Have lung disease or inflammation that required steroid treatment.
• Have active inflammatory bowel disease or intestinal blockage.
• Have any condition or mental health issue that could interfere with the study.
• Are participating in other clinical trials or have received similar therapies before.
• Have received a live vaccine within 30 days before starting the study.
• Have had an organ or stem cell transplant.