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PD-L1 Inhibitor

Radiation + Dostarlimab for Endometrial Cancer

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test if adding Dostarlimab to standard radiation therapy can improve outcomes for women with endometrial cancer that has spread beyond the uterus and has a specific genetic feature.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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%

Pain

20%

Urine discoloration

20%

Paresthesia

20%

Sore throat

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Insomnia

13%

Palpitations

13%

Thrush

13%

Pain in extremity

13%

Neutrophil count decreased

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

Skin ulceration

Oral pain

Obesity

Oral hemorrhage

Encephalopathy

Generalized muscle weakness

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

Osteoporosis

Urinary retention

Papulopustular rash

Skin infection

Endocarditis infective

Erectile dysfunction

Hematuria

Stroke

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Urinary frequency

Superficial thrombophlebitis

Tremor

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation and DostarlimabExperimental 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity modulated radiation therapy (IMRT)

2019

Completed Phase 2

~80

Dostarlimab

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,589 Total Patients Enrolled

19 Trials studying Endometrial Cancer

4,449 Patients Enrolled for Endometrial Cancer

Tesaro, Inc.Industry Sponsor

56 Previous Clinical Trials

10,525 Total Patients Enrolled

3 Trials studying Endometrial Cancer

114 Patients Enrolled for Endometrial Cancer

Ying Liu, MD, MPHPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Dostarlimab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04774419 — Phase 2

Endometrial Cancer Research Study Groups: Radiation and Dostarlimab

Endometrial Cancer Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT04774419 — Phase 2

Dostarlimab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774419 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people suffering from this condition are being given the opportunity to participate in this trial?

"The clinicaltrials.gov website indicates that this research is actively recruiting patients. The listing was first posted on April 2nd, 2021 and was last updated on November 15th, 2022. There are 31 vacancies open for participants across 7 sites."

Answered by AI

In how many places is this research conducted?

"There are 7 sites currently enrolling patients for this trial, with locations in Basking Ridge, Commack, Harrison and 4 other places. If you enroll, try to choose the location closest to you to limit travel."

Answered by AI

Are people with the specified medical condition able to participate in this trial right now?

"The clinicaltrials.gov website suggests that this study is still actively recruiting patients. The trial was originally posted on April 2nd, 2021 and the most recent update was on November 15th, 2022."

Answered by AI

What is the mortality rate associated with Dostarlimab?

"The available data only supports the safety of Dostarlimab, not its efficacy, so it received a score of 2."

Answered by AI

What is the Dostarlimab research landscape?

"Dostarlimab was first researched in 2010 at City of Hope. As of now, there are 2 completed studies and 40 live studies underway. A significant portion of these ongoing studies are situated in Basking Ridge, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774419.

All > Endometrial Cancer