Nivolumab + Ipilimumab for Uterine Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well nivolumab alone or in combination with ipilimumab works in treating patients with uterine cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Research Team
Suzanne George
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
This trial is for patients with advanced uterine leiomyosarcoma, a type of cancer that has spread and is typically incurable. Participants must have had at least one prior chemotherapy treatment, be in good physical condition (ECOG 0 or 1), and not be pregnant or breastfeeding. They should not have active brain metastases, severe allergies to monoclonal antibodies, HIV/AIDS, hepatitis B/C infection, uncontrolled illnesses, or a history of certain autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab alone or in combination with ipilimumab. Cohort A receives nivolumab every 2 weeks for up to 46 doses. Cohort B receives nivolumab and ipilimumab every 21 days for up to 4 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor