Nivolumab +/− Ipilimumab for Endometrial Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.
Will I have to stop taking my current medications?
The trial requires that any prior therapy directed at the tumor, including chemotherapy, targeted agents, biologic agents, immunologic agents, and investigational agents, must be stopped at least 4 weeks before joining the study. Hormonal therapy must be stopped at least 3 weeks before joining. If you are on chronic steroid therapy, you may need to adjust your dose to 10mg or less of prednisone or equivalent.
What data supports the effectiveness of the drug Nivolumab +/− Ipilimumab for Endometrial Cancer?
What safety information is available for the combination of Nivolumab and Ipilimumab?
The combination of Nivolumab and Ipilimumab can cause immune-related side effects in about half of the patients, such as diarrhea, liver inflammation, and lung issues. These side effects can be serious but are often reversible with proper management, including the use of steroids. Close monitoring by healthcare professionals is important to manage these side effects effectively.678910
How is the drug combination of Nivolumab and Ipilimumab unique for treating endometrial cancer?
Research Team
Haider Mahdi, MD
Principal Investigator
NRG Oncology
Eligibility Criteria
This trial is for adults over 18 with recurrent endometrial cancer that has a deficient mismatch repair system. Eligible participants may have had prior treatments but must be in good health with stable vital signs and organ function. Those with certain autoimmune diseases, severe allergies to the drugs being tested, or who are pregnant are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab and ipilimumab or nivolumab alone, with cycles repeating every 3 weeks for up to 8 cycles, then every 4 weeks thereafter
Maintenance Therapy
Patients achieving complete response receive nivolumab for an additional 12 months
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
NRG Oncology
Collaborator