NCT04774419 · Memorial Sloan Kettering Cancer Center
Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
What this study is about
This study will test whether the combination of radiation and Dostarlimab is an effective treatment for women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery.
View original scientific description
This study will test whether the combination of radiation and Dostarlimab is an effective treatment for women with MMR-D/MSI-H endometrial cancer who have recently undergone surgery.
Interventions
RADIATION
Intensity modulated radiation therapy (IMRT)
To the pelvic nodes and vaginal cuff (total dose of 45-50.4Gy at 1.8 Gy per fraction) for 5-6 weeks.
DRUG
Dostarlimab
IV Dostarlimab every 3 weeks for 4 cycles followed by 1 dose of 1000mg (C5). Patients will receive a maximum of 5 cycles of Dostarlimab.
RADIATION
Hypofractionated IMRT
Treatment will consist of short-course, hypofractionated IMRT to deliver 25 Gy to the vaginal cuff and pelvic lymph nodes in 5 daily fractions over one week.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs) (Safety Run-in only)
Time frame: up to 8 weeks
6-18 patients will be enrolled during a safety run-in period to assess toxicities. (NCI Common Terminology Criteria for Adverse Events version 5.0)
Progression-free (PFS)
Time frame: 2 years
PFS will be defined as the number of days from the date of the first dose of drug to the date of an event of disease progression/recurrence, according to RECIST criteria version 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older
- ECOG performance status 0-1
- Endometrial cancer: all histologies (submission of pathology report is required for all patients who underwent surgery outside of MSK)
- MMR-D or MSI-H (submission of report\[s\] required for. patients who underwent testing outside of MSK
- Patients with hypermethylation of MMR gene promoters (MLH1, MSH2, MSH6 or PMS2) will be included
- POLE-mutated endometrial cancers will be included
- Patients with stage IIIB and IIIC2 are not eligible
- Must have undergone a complete surgical staging and have stage III/IVA disease.
- Patients with measurable disease (RECIST 1.1) after surgery are NOT eligible.
- PatienSurgery completed between 3 weeks and 12 weeks (inclusive) before cycle 1 day 1 of therapy, and must have adequately recovered from surgery and any complications of surgery.ts with isolated tumor cells in lymph nodes found on surgery will be counted as clinical stage III disease
- Surgery complet
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Collaborators
Tesaro, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations