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

Conditions

• Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Apr 2, 2021

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

62 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Radiation and Dostarlimab (THIS ARM IS COMPLETED)
  Patients will undergo standard 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 and receive 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.
• Experimental: Hypofractionated IMRT and Dostarlimab
  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. Participants will receive TSR-042 500mg every 3 weeks over 30 minutes for 4 cycles, followed by 1 dose of 1000mg for cycle 5. For this group, in those patients who have delays in C2 of dostarlimab and/or are unable to receive the 2nd dose of dostarlimab, hypofractionated radiation may proceed independently per discretion of treating investigator in consultation with study PI. Continuation of radiation therapy will be at the discretion of the radiation oncologist in discussion with study PI/co-PIs, and can be initiated/continued independent of dostarlimab dosing. Follow-up must continue regardless of radiation treatment received.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) (Safety Run-in only) [ Time Frame: up to 8 weeks ]

Central Contacts

• Ying Liu, MD, MPH
  646-888-4946
  [email protected]
• Roisin O'Cearbhaill, MD
  646-888-4227

Locations (7)

Find similar trials in Basking Ridge, NJ

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