Testing the Immunotherapy Drug, Nivolumab With or Without the Immunotherapy Drug, Ipilimumab for Recurrent dMMR Endometrial Cancer
https://www.facingourrisk.org/research-clinical-trials/study/362/testing-an-immunotherapy-drug-nivolumab-with-or-without-the-immunotherapy-drug-ipilimumab-for-recurrent-dmmr-endometrial-cancer
Clinicaltrials.gov identifier:
NCT05112601 (https://clinicaltrials.gov/show/NCT05112601)
Treatment
Phase 2 treatment trial enrolling adult women with recurrent endometrial cancer whose tumors have a deficient mismatch repair system (dMMR).
Study Contact Information:
Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below.
About The Study
This clinical trial is studying two different immunotherapy approaches for people with endometrial cancer that has come back after treatment (recurrent). It focuses on tumors that have a deficiency in the mismatch repair system (dMMR) — a change in the tumor cells that leads to many DNA errors and may make the cancer more responsive to immunotherapy.
Researchers want to see whether giving nivolumab together with ipilimumab works better to shrink tumors and delay the cancer’s return than giving nivolumab by itself. Both nivolumab and ipilimumab are immunotherapy drugs called monoclonal antibodies that help the immune system recognize and attack cancer cells.
What the Study Involves
If a person joins this study, they will be randomly placed into one of two groups:
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Group 1: Receive nivolumab combined with ipilimumab.
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Group 2: Receive nivolumab alone.
Treatment is given through intravenous (IV) infusions at scheduled intervals. Some participants may also have tissue and blood samples collected, as well as imaging studies like CT or MRI, to monitor the cancer.
Participants will continue treatment until the cancer progresses, side effects become unacceptable, or they complete the planned treatment. After treatment, participants are followed regularly to check their health and monitor cancer outcomes.
This Study is Open To:
This study is open to:
- Adult women (age 18 and older)
- People with recurrent endometrial cancer whose tumors have deficient mismatch repair (dMMR) confirmed by testing
- People may have received previous treatments, including:
- one or two prior chemotherapy treatments.
- prior immunotherapy (anti-PD-1 or anti-PD-L1) was given in combination with chemotherapy or radiation, the cancer initially responded fully, and it returned at least 12 months after the last immunotherapy dose.
- prior radiation therapy for endometrial cancer, as long as radiation ended at least 4 weeks before joining the study.
- prior hormonal therapy for endometrial cancer, as long as the hormonal treatment was stopped at least 3 weeks before joining the study.
This Study is Not Open To:
This study is not open to:
- People who do not have recurrent endometrial cancer
- People whose tumors do not have deficient mismatch repair
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.