Study on BMS-986205 and Nivolumab for Endometrial Cancer or Carcinosarcoma That Hasn't Responded to Treatment

Inclusion Criteria

• Have recurrent or persistent endometrial cancer or carcinosarcoma, confirmed by medical tests.
• Have at least one tumor that can be measured by scans or exams.
• Be a female aged 18 or older with a life expectancy of at least 12 weeks.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have recovered from any recent surgery, radiation, or chemotherapy side effects to a mild level.
• Have had one prior platinum-based chemotherapy treatment for endometrial cancer or carcinosarcoma.
• Have adequate blood cell counts and organ function based on recent lab tests.
• Not be pregnant and agree to use effective birth control during the study and for five months after.
• Provide a tissue sample from a previous biopsy or undergo a new biopsy if needed.
• Be willing to follow the study protocol, including treatments and follow-up visits.
• Agree to participate in a related genomic profiling study.
• Sign an informed consent form allowing the release of personal information.

Exclusion Criteria

• Be involved in planning or conducting the study.
• Have a known deficiency in MMR or MSI-H.
• Have participated in another clinical study with an investigational product in the last four weeks.
• Have previously received treatment with IDO, PD-1, PD-L1 inhibitors, or anti-CTLA4.
• Have another primary cancer unless treated and inactive for at least three years.
• Have received any cancer treatment within 21 days before the study starts.
• Have had major surgery within the last four weeks.
• Have a heart condition with a QTc interval of 470 ms or more.
• Be using immunosuppressive medication within 28 days before starting the study, except for certain low-dose steroids.
• Have had severe immune-related side effects from previous treatments.
• Have an autoimmune disease or inflammatory bowel disease.
• Have a history of primary immunodeficiency or lung disease requiring steroids.
• Have had an organ transplant.
• Have a known allergy to nivolumab.
• Have uncontrolled illnesses or infections.
• Have a history of tuberculosis.
• Have brain metastases requiring treatment.
• Have uncontrolled seizures.
• Have received a live vaccine within 30 days before the study.
• Be pregnant or breastfeeding, or not willing to use birth control.
• Have conditions affecting the absorption of oral medication.
• Have refractory ascites needing frequent drainage.
• Have a history of methemoglobinemia or related conditions.
• Have G6PD deficiency or high blood methemoglobin levels.
• Have a history of reaction to methylene blue or serotonin syndrome.