Radiation and Dostarlimab for Endometrial Cancer After Surgery
This study is testing if combining radiation therapy (Intensity Modulated Radiation Therapy or Hypofractionated IMRT) with Dostarlimab, a drug given through an IV, is an effective treatment for women with endometrial cancer. You may be able to join if you are 18 or older, have endometrial cancer that has specific biomarkers (MMR-D, MSI-H, or POLE-mutated), and have recently had surgery. The researchers will be looking at how safe the treatment is and how long people live without their cancer growing or coming back (progression-free survival) over two years. The current status of this study is unclear, but it plans to enroll 62 participants.
- Study design
- This is an interventional study with a planned enrollment of 62 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for progression-free survival for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04774419
Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~62 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Intensity modulated radiation therapy (IMRT)DostarlimabHypofractionated IMRT
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs) (Safety Run-in only)
Measured over up to 8 weeks
+1 more outcome measured
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Ying Liu, MD, MPH · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 or POLE-mutated (submission of report\[s\] required for. patients who underwent testing outside of MSK POLE-mutated endometrial cancers will be included regardless of MMR/MSI status and limited to up to 3 patients per group.
Patients with hypermethylation of MMR gene promoters (MLH1, MSH2, MSH6 or PMS2) will be included
POLE-mutated endometrial cancers will be included
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 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.
Has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential, and agrees use an adequate method of contraception from screening through 150 days after the last dose of study treatment, or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate birth control method throughout the study, starting with the screening visit through 150 days after the last dose of study treatment. See list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment.
Demonstrate adequate organ function as defined below. All screening labs should be performed within 14 days of treatment initiation.
Absolute neutrophil count (ANC) ≥1,500 /mcL
Platelets ≥100,000 / mcL
Hemoglobin ≥9 g/dL
Creatinine Clearance GFR ≥ 45
Serum total bilirubin ≤ 1.5 X ULN (patients with known Gilbert's disease Serum total bilirubin who have bilirubin level ≤ 3 x ULN may be enrolled)
AST and ALT 3 ULN OR ≤ 5 X ULN for subjects with liver metastases
TSH within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal free T4 level is required.
Exclusion
Has had prior chemotherapy, targeted therapy, or investigational therapy for endometrial cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent for endometrial cancer.
Unfit for Radiation Therapy due to the following:
Has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
Patients with a prior history of pelvic radiation
Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.
Hypersensitivity to Dostarlimab or any of its excipients
Patients with diagnosis of immunodeficiency or patients receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Total systemic steroid dose cannot exceed an equivalent of 10mg of prednisone daily and dose must be stable for at least 4 weeks prior to initiating protocol therapy
Has active TB (Bacillus tuberculosis)
Has evidence of active, non-infectious pneumonitis.
Has history of interstitial lung disease
Has an active infection requiring systemic therapy with intravenous antibiotics
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment or patients requiring immunosuppressive therapy for the autoimmune disease. The following are exceptions to this criterion:
Subjects with vitiligo or alopecia
Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Subjects with psoriasis not requiring systemic treatment.
Subjects with history of immune-related hyperthyroidism with total thyroidectomy currently in remission
Select situations after approval of study PI
Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Has received a live vaccine within 30 days of planned start of study therapy.
Is unwilling to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. The use of LAR for cognitively impaired patients is not permitted.
What this trial measures
- Incidence of dose limiting toxicities (DLTs) (Safety Run-in only)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)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