A Phase II Study of Dostarlimab Immunotherapy in People with Mismatch Repair-Deficient Endometrial Who Wish to Preserve Fertility
Treatment
Phase 2 treatment study for people with MSI-H or dMMR early-stage endometrial cancer.
Clinicaltrials.gov identifier:NCT04165772
About the Study
Researchers are testing the safety and effectiveness of the dostarlimab (Jemperli) as a non-surgical treatment option for patients with dMMR or endometrial cancer and a strong desire for fertility preservation. Standard treatment for 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 or endometrial cancers. This study is evaluating whether dostarlimab can eliminate tumors in people with dMMR or endometrial cancer. These tumors have changes that make it difficult for cells to repair mistakes in their . They may also be more likely to respond to .
Doctors will evaluate participants' response to dostarlimab; people whose tumors respond completely can be followed with close surveillance and no surgery.
This Study is Open To:
You may be eligible to participate if you:
- Have been diagnosed with 1 or 2 .
- Have had tumor testing that shows your cancer is or .
This Study is NOT Open To:
You would not be eligible if:
- You have received chemotherapy or for your .
- 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
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.
Locations:
Connecticut
City: Hartford RECRUITING
Facility: Hartford Healthcare (Data Collection)
Contact Info:
860-972-4700
Florida
City: Miami RECRUITING
Facility: Baptist Alliance MCI (Data Collection Only)
Contact Info:
786-373-3436
New Jersey
City: Basking Ridge RECRUITING
Facility: Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Contact Info:
646-888-4189
Andrea Cercek, MD
City: Middletown RECRUITING
Facility: Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Contact Info:
646-888-4189
City: Montvale RECRUITING
Facility: Memorial Sloan Kettering Bergen - Limited Protocol Activities
Contact Info:
646-888-4189
New York
City: Commack RECRUITING
Facility: Memorial Sloan Kettering Commack - Limited Protocol Activities
Contact Info:
646-888-4189
Andera Cercek, MD
City: Harrison RECRUITING
Facility: Memorial Sloan Kettering Westchester - Limited Protocol Activities
Contact Info:
646-888-4189
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
646-888-4189
646-888-4181
Andrea Cercek, MD
City: Uniondale RECRUITING
Facility: Memorial Sloan Kettering Nassau - Limited Protocol Activities
Contact Info:
646-888-4189
Pennsylvania
City: Allentown RECRUITING
Facility: Lehigh Valley Health Network (Data Collection Only)
Contact Info:
610-402-7880
Treatment
Phase 2 treatment study for people with MSI-H or dMMR early-stage endometrial cancer.
Clinicaltrials.gov identifier:NCT04165772