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PD-L1 Inhibitor

Radiation + Dostarlimab for Endometrial Cancer

Phase 2

Recruiting

Led By Ying Liu, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-1

Age 18 years or older

Must not have

Unfit for Radiation Therapy due to specified conditions

Has had prior chemotherapy, targeted therapy, or investigational therapy for endometrial cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing if combining radiation and Dostarlimab can effectively treat women with a specific type of endometrial cancer after surgery.

Who is the study for?

This trial is for women aged 18+ with MMR-D/MSI-H endometrial cancer who've had surgery. They must be in good health, not pregnant, agree to contraception, and have no severe allergies to Dostarlimab or its components. Exclusions include prior pelvic radiation, immune-related thyroidectomy in remission, certain autoimmune diseases unless approved by the study PI.

What is being tested?

The effectiveness of combining radiation therapy (IMRT) with a drug called Dostarlimab is being tested on women with specific genetic types of endometrial cancer post-surgery. The goal is to see if this combination improves treatment outcomes compared to what's currently available.

What are the potential side effects?

Dostarlimab may cause fatigue, allergic reactions at the infusion site, skin rash or itching. It can also lead to more serious conditions like inflammation in various organs including lungs and intestines and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My cancer was surgically staged and is at stage III/IVA.

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I have endometrial cancer and can provide a pathology report if my surgery was done outside of MSK.

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My cancer is MMR deficient or has high microsatellite instability.

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My endometrial cancer has a POLE mutation.

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My cancer is considered stage III due to tumor cells in lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo radiation therapy due to certain health conditions.

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I have received treatments like chemotherapy for endometrial cancer before.

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I have active tuberculosis.

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I am currently on IV antibiotics for an infection.

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I have not received a live vaccine in the last 30 days.

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I have lung inflammation not caused by an infection.

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I have been treated with specific immune therapies for endometrial cancer.

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I have a history of lung scarring or fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Progression-free (PFS)

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002

80%

Anemia

80%

Fatigue

73%

Abdominal pain

67%

CD4 lymphocytes decreased

67%

Alkaline phosphatase increased

67%

Nausea

60%

Anorexia

60%

Constipation

53%

Platelet count decreased

53%

Hyperglycemia

47%

Thromboembolic event

47%

Weight loss

47%

Anxiety

47%

Hypoalbuminemia

40%

Vomiting

40%

Peripheral motor neuropathy

40%

Blood bilirubin increased

40%

Dyspnea

40%

Hypertension

33%

Edema limbs

33%

Abdominal distension

33%

Aortic valve disease

33%

Back pain

33%

Diarrhea

33%

Fever

33%

Hypocalcemia

33%

Sinus tachycardia

27%

Depression

27%

White blood cell decreased

27%

Chills

27%

Ascites

27%

Hyponatremia

20%

Sore throat

20%

Urine discoloration

20%

Pain

20%

Paresthesia

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Neutrophil count decreased

13%

Insomnia

13%

Pain in extremity

13%

Palpitations

13%

Thrush

13%

Confusion

13%

Dehydration

13%

Fall

13%

Cardiac troponin T increased

13%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

13%

Bloating

13%

Dry mouth

13%

Dysphagia

13%

Dysuria

13%

Flatulence

13%

Gastroesophageal reflux disease

13%

Glucosuria

13%

Hiccups

13%

Hypercalcemia

13%

Hyperkalemia

13%

Hypokalemia

13%

Hypophosphatemia

13%

Hypothyroidism

13%

Localized edema

Urinary retention

Obesity

Urinary frequency

Skin infection

Hematuria

Erectile dysfunction

Generalized muscle weakness

Hemorrhoidal hemorrhage

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Oral hemorrhage

Oral pain

Osteoporosis

Papulopustular rash

Skin ulceration

Stroke

Superficial thrombophlebitis

Thyroid stimulating hormone increased

Tremor

Encephalopathy

Endocarditis infective

Eye disorders - Other, specify

Pelvic pain

Prostatic obstruction

Pruritus

Rash acneiform

Rectal pain

Renal calculi

Reproductive system and breast disorders - Other, specify

Wheezing

Portal vein thrombosis

Vaginal dryness

Alopecia

Arthralgia

Arthritis

Bacteremia

Biliary tract infection

Blood lactate dehydrogenase increased

Buttock pain

Dry skin

Dysgeusia

Flank pain

Gastric anastomotic leak

Gastric ulcer

Gastritis

Gastrointestinal disorders - Other, specify

Gastrointestinal pain

Hyperlipidemia

Hypoglycemia

Lethargy

Memory impairment

Mucositis oral

Muscle cramp

Muscle weakness lower limb

Myocarditis

Restlessness

Scleral disorder

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Niraparib+Dostarlimab + Radiation

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Radiation and Dostarlimab (THIS ARM IS COMPLETED)Experimental Treatment2 Interventions

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.

Group II: Hypofractionated IMRT and DostarlimabExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated IMRT

2013

N/A

~90

Intensity modulated radiation therapy (IMRT)

2019

Completed Phase 2

~80