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Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Intensity modulated radiation therapy (IMRT)

    Radiation

    To the pelvic nodes and vaginal cuff (total dose of 45-50.4Gy at 1.8 Gy per fraction) for 5-6 weeks.

  • Dostarlimab

    Drug

    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.

  • Hypofractionated IMRT

    Radiation

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Radiation and Dostarlimab (THIS ARM IS COMPLETED)Experimental treatment 2 interventions
Group B: Hypofractionated IMRT and DostarlimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs) (Safety Run-in only)

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)

Time frame
up to 8 weeks
2

Progression-free (PFS)

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Tesaro, Inc.

Collaborator

Source ClinicalTrials.gov
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