Study on the Safety and Effectiveness of Dostarlimab and LB-100 for Treating Ovarian Clear Cell Carcinoma

Inclusion Criteria

• Able to provide signed consent to participate in the study.
• Aged between 18 and 75 years.
• Willing and able to follow the study protocol, including attending scheduled visits and undergoing treatment.
• Diagnosed with recurrent clear cell ovarian, peritoneal, or fallopian tube cancer.
• Have received at least one prior treatment for recurrent disease or have platinum-resistant or refractory disease.
• Have test results showing no specific genetic mutations (PPP2R1A mutations).
• Have measurable disease based on specific criteria, with at least one tumor that can be accurately measured.
• Have a performance status indicating they are fully active or have some restrictions but can still perform light work.
• Expected to live at least 12 more weeks.
• Have normal organ and bone marrow function based on specific blood test results.
• For women of childbearing potential, must have a negative pregnancy test and agree to use effective contraception during the study.
• Women considered post-menopausal if they meet specific criteria related to age and menstrual history.

Exclusion Criteria

• Participating in another clinical study with an investigational product in the last 28 days.
• Previous treatment with certain immune therapies (anti-CTLA-4 or anti-PDL-1/PD-1 antibodies).
• Have tumors with specific genetic characteristics (mismatch repair deficient or microsatellite instability-high).
• Receiving treatment in another clinical study, unless it is observational.
• Recently received anticancer therapy within 21 days before starting the study treatment.
• Have unresolved side effects from previous cancer treatments, except for certain conditions like hair loss.
• Receiving other cancer treatments concurrently.
• Had major surgery within 28 days before starting the study treatment.
• History of organ transplantation.
• Have active or recent autoimmune or inflammatory disorders, with some exceptions.
• Have uncontrolled illnesses or infections that could interfere with the study.
• Have active infections like tuberculosis, hepatitis B or C, or HIV, unless under control.
• History of another primary cancer, with some exceptions.
• Have untreated brain metastases or spinal cord compression.
• Have a heart condition affecting the QT interval.
• Using immunosuppressive medication recently, with some exceptions.
• Received a live vaccine recently.
• Pregnant or breastfeeding women, or women not using effective birth control.
• Known allergy to study drugs.
• Have unresolved bowel obstruction.
• Judged by the investigator as unsuitable for the study.