A Phase II Study of Dostarlimab Immunotherapy in People with Mismatch Repair-Deficient Endometrial Who Wish to Preserve Fertility
https://www.facingourrisk.org/research-clinical-trials/study/434 /a-phase-ii-study-of-dostarlimab-immunotherapy-in-people-with-mismatch-repair-deficient-endometrial-who-wish-to-preserve-fertility
Clinicaltrials.gov identifier:
NCT04165772 (https://clinicaltrials.gov/show/NCT04165772)
Treatment
Phase 2 treatment study for people with MSI-H or dMMR early-stage endometrial cancer.
About the Study
Researchers are testing the safety and effectiveness of the immunotherapy dostarlimab (Jemperli) as a non-surgical treatment option for patients with early-stage dMMR or MSI-H endometrial cancer and a strong desire for fertility preservation. Standard treatment for early-stage endometrial cancer usually includes surgery to remove the uterus (hysterectomy). This means that people who hope to become pregnant in the future generally cannot preserve their fertility through standard surgical treatment.
Dostarlimab is currently used to treat advanced dMMR or MSI-H endometrial cancers. This study is evaluating whether dostarlimab can eliminate tumors in people with early-stage dMMR or MSI-H endometrial cancer. These tumors have changes that make it difficult for cells to repair mistakes in their DNA. They may also be more likely to respond to immunotherapy.
Doctors will evaluate participants' response to dostarlimab; people whose tumors respond completely can be followed with close surveillance and no surgery.
What the Study Involves
All participants will receive the study drug, dostarlimab.
- Dostarlimab will be given as an intravenous injection (injection in the vein) every 3 weeks for 6 months. .
- Doctors will monitor the cancer during treatment using imaging and other tests.
- At the end of the 6-month treatment period:
- People whose cancer has completely responded may be able to continue with close monitoring instead of having surgery.
- People who still have evidence of cancer may undergo a hysterectomy as standard treatment.
After treatment, participants will continue to be followed to monitor their health and the status of their cancer.
This Study is Open To:
You may be eligible to participate if you:
- Have been diagnosed with stage 1 or stage 2 endometrial cancer.
- Have had tumor testing that shows your cancer is MSI-H or dMMR.
This Study is Not Open To:
You would not be eligible if:
- You have received chemotherapy or immunotherapy for your endometrial cancer.
- If you have received progestin-only therapy, you must stop it at least 1-week before starting treatment.
- Participants may use combination estrogen/progesterone contraceptives while on study
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.