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Addition of Pembrolizumab to Radiation Treatment for Newly Diagnosed Early Stage MSI-High Endometrial Cancer
Clinicaltrials.gov identifier:
NCT04214067
Treatment:
Endometrial
Study Contact Information:
Principal Investigator: Floor Backes
For additional information: Use the contacts listed per each study location.
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
About the Study
The purpose of this study is to determine whether the addition of the immunotherapy agent, pembrolizumab (Keytruda) to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer recurrence in patients with newly diagnosed stage I-II endometrial cancer that is MSI-High.
Type of Study
This is a randomized, 2-arm, open-label, phase 3 study.
- The study has 2-arms
- Patients assigned to group 1 will receive standard-of-care radiation
- Patients assigned to group 2 will receive standard-of-care radiation and immunotherapy
- The study is randomized. Patients will be selected by chance and placed into one of the two groups.
- The study is open-label, all patients will know which group they have been placed into.
What the Study Entails
Group 1 treatment
Patients will undergo pelvic external beam radiation therapy (EBRT) daily for 5-6 weeks and vaginal brachytherapy completed within 7 days after completion of EBRT in the absence of disease progression or until treatment discontinuation for another reason.
Group 2 treatment
Patients will undergo EBRT and brachytherapy as in Group 1. Within 7 days prior to the start of radiation therapy, patients in Group 2 will also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment with pembrolizumab repeats every 6 weeks for up to 1 year (9 cycles) in the absence of disease progression or until treatment discontinuation for another reason.
Followup
After completion of study treatment, patients are followed-up every 3 months for 2 years and then every 6 months for 3 years.
Study Sites
- Birmingham: University of Alabama at Birmingham Cancer Center
Contact: Tracey Myrick by phone: 205-934-0220 or by email
- Concord: John Muir Medical Center-Concord Campus
Contact: 925-674-2580 - La Jolla: UC San Diego Moores Cancer Center
Contact: UCSD Clinical Trial Office by phone: 858-822-5354 or by email - Los Angeles: UCLA / Jonsson Comprehensive Cancer Center
Contact: UCLA Clinical Trial Office by phone: 888-798-0719 - Walnut Creek: John Muir Medical Center-Walnut Creek
Contact: 925-941-4246
- New Haven: Smilow Cancer Center/Yale-New Haven Hospital
Contact: 203-785-5702 or by email - New Haven:
- Fort Myers: Florida Gynecologic Oncology
Contact: 800-874-7502
- Atlanta: Northside Hospital
Contact: 404-303-3355 or by email - Marietta: Wellstar Kennestone Hospital
Contact: 470-793-4071 or by email - Newnan: CTCA at Southeastern Regional Medical Center
Contact: 770-400-6629 - Savannah: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Contact: 912-819-5704 or by email
- Boise: Saint Luke's Cancer Institute - Boise
Contact: 208-381-2774 or by email - Fruitland: Saint Luke's Cancer Institute - Fruitland
Contact: 208-381-2774 or by email - Meridian: Saint Luke's Cancer Institute - Meridian
Contact: 208-381-2774 or by email - Nampa: Saint Luke's Cancer Institute - Nampa
Contact: 208-381-2774 or by email - Twin Falls: Saint Luke's Cancer Institute - Twin Falls
Contact: 208-381-2774 or by email
- Centralia: Centralia Oncology Clinic
Contact: 217-876-4740 or by email - Chicago: Northwestern University
Contact: 312-695-1301 or by email - Chicago: University of Chicago Comprehensive Cancer Center
Contact: 773-702-8222 or by email - Decatur: Cancer Care Specialists of Illinois - Decatur
Contact: 217-876-4740 or by email - Decatur: Decatur Memorial Hospital
Contact: 217-876-4740 or by email - Effingham: Crossroads Cancer Center
Contact: 217-876-4740 or by email - Evanston: NorthShore University HealthSystem-Evanston Hospital
Contact: 847-570-2109 - Geneva: Northwestern Medicine Cancer Center Delnor
Contact: 630-352-5360 or by email - Glenview: NorthShore University HealthSystem-Glenbrook Hospital
Contact: 847-570-2109 - Highland Park: NorthShore University HealthSystem-Highland Park Hospital
Contact: 847-570-2109 - New Lenox: UC Comprehensive Cancer Center at Silver Cross
Contact: 773-702-8222 or by email - O'Fallon: Cancer Care Center of O'Fallon
Contact: 217-876-4762 or by email - Orland Park: University of Chicago Medicine-Orland Park
Contact: 773-702-8222 or by email - Springfield: Southern Illinois University School of Medicine
Contact: 217-545-7929 - Springfield: Springfield Clinic
Contact: 800-444-7541 - Springfield: Memorial Medical Center
Contact: 217-788-3528 - Warrenville: Northwestern Medicine Cancer Center Warrenville
Contact: 630-352-5360 or by email - Zion: Midwestern Regional Medical Center
Contact: 412-339-5294 or by email
- Ames: Mary Greeley Medical Center
Contact: Site Public Contact 515-956-4132 - Ames: McFarland Clinic PC - Ames
Contact: 515-239-4734 or by email
- Edgewood: Saint Elizabeth Medical Center South
Contact: 859-301-5473 or by email - Lexington: Baptist Health Lexington
Contact: 859-260-6425
- Metairie: East Jefferson General Hospital
Contact: 504-210-3539 or by email - New Orleans: Louisiana State University Health Science Center
Contact: 504-210-3539 or by email - New Orleans: University Medical Center New Orleans
Contact: 504-210-3539 or by email
- Bath: MaineHealth Coastal Cancer Treatment Center
Contact: 412-339-5294 or by email - Biddeford: MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Contact: by email - Portland: Maine Medical Center-Bramhall Campus
Contact: 207-885-7565 - Sanford: MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Contact: by email - Scarborough: Maine Medical Center- Scarborough Campus
Contact: 207-396-8090 or by email
- Dearborn: Beaumont Hospital - Dearborn
Contact: 248-551-7695 - Detroit: Wayne State University/Karmanos Cancer Institute
Contact: 313-576-9790 or by email - Farmington Hills: Weisberg Cancer Treatment Center
Contact: 313-576-9790 or by email - Royal Oak: William Beaumont Hospital-Royal Oak
Contact: 248-551-7695 - Troy: William Beaumont Hospital - Troy
Contact: 248-551-7695
- Edina: Fairview Southdale Hospital
Contact: 952-993-1517 or by email - Minneapolis: Abbott-Northwestern Hospital
Contact: 952-993-1517 or by email - Monticello: Monticello Cancer Center
Contact: 952-993-1517 or by email - Saint Cloud: Coborn Cancer Center at Saint Cloud Hospital
Contact: 877-229-4907 or by email - Waconia: Ridgeview Medical Center
Contact: 952-993-1517 or by email
- Farmington: Parkland Health Center - Farmington
Contact: 314-996-5569 - Saint Louis: Washington University School of Medicine
Contact: 800-600-3606 or by email - Saint Louis: Missouri Baptist Medical Center
Contact: 314-996-5569 - Saint Louis: Mercy Hospital Saint Louis
Contact: 314-251-7066 - Sainte Genevieve: Sainte Genevieve County Memorial Hospital
Contact: 314-996-5569 - Springfield: Mercy Hospital Springfield
Contact: 417-269-4520 - Sullivan: Missouri Baptist Sullivan Hospital
Contact: 314-996-5569 - Sunset Hills: Missouri Baptist Outpatient Center-Sunset Hills
Contact: 314-996-5569
- Bozeman: Bozeman Deaconess Hospital
Contact: 406-969-6060 or by email
- Omaha: Nebraska Methodist Hospital
Contact: 402-354-5144
- Las Vegas: Women's Cancer Center of Nevada
Contact: 702-693-6870 or by email
- Basking Ridge: Memorial Sloan Kettering Basking Ridge
Contact: 212-639-7592 - Middletown: Memorial Sloan Kettering Monmouth
Contact: 212-639-7592 - Montvale: Memorial Sloan Kettering Bergen
Contact: 212-639-7592
- Albuquerque: University of New Mexico Cancer Center
Contact: 505-925-0366 or by email
- Albany: Women's Cancer Care Associates LLC
Contact: 518-458-1390 or by email - Brooklyn: New York-Presbyterian/Brooklyn Methodist Hospital
Contact: 718-780-3677 or by email - Commack: Memorial Sloan Kettering Commack
Contact: 212-639-7592 - Flushing: The New York Hospital Medical Center of Queens
Contact: 412-339-5294 or by email - Harrison: Memorial Sloan Kettering Westchester
Contact: 212-639-7592 - Lake Success: Northwell Health/Center for Advanced Medicine
Contact: 516-734-8896 - New Hyde Park: Long Island Jewish Medical Center
Contact: 516-734-8896 - New York: Memorial Sloan Kettering Cancer Center
Contact: 212-639-7592 - Stony Brook: Stony Brook University Medical Center
Contact: 800-862-2215 - Uniondale: Memorial Sloan Kettering Nassau
Contact: 212-639-7592
- Chapel Hill: UNC Lineberger Comprehensive Cancer Center
Contact: 877-668-0683 or by email - Greensboro: Cone Health Cancer Center
Contact: 336-832-0821 or by email
- Bismarck: Sanford Bismarck Medical Center
Contact: 701-323-5760 or by email - Fargo: Sanford Broadway Medical Center
Contact: 701-323-5760 or by email - Fargo: Sanford Roger Maris Cancer Center
Contact: 701-234-6161 or by email
- Centerville: Dayton Physicians LLC-Miami Valley South
Contact: 937-528-2900 or by email - Centerville: Miami Valley Hospital South
Contact: 937-528-2900 or by email - Cleveland: MetroHealth Medical Center
Contact: 216-778-8526 or by email - Columbus: Ohio State University Comprehensive Cancer Center
Contact: 800-293-5066 or by email - Columbus: Riverside Methodist Hospital
Contact: 614-566-4475 or by email
- Oklahoma: University of Oklahoma Health Sciences Center
Contact: 405-271-8777 or by email
- Clackamas: Clackamas Radiation Oncology Center
Contact: 503-215-2614 or by email - Providence Cancer Institute Clackamas Clinic
Contact: 503-215-2614 or by email - Gresham: Legacy Mount Hood Medical Center
Contact: 503-413-2150 - Newberg: Providence Newberg Medical Center
Contact: 503-215-2614 or by email - Portland: Legacy Good Samaritan Hospital and Medical Center
Contact: 800-220-4937 or by email - Portland: Providence Portland Medical Center
Contact: 503-215-2614 or by email - Portland: Providence Saint Vincent Medical Center
Contact: 503-215-2614 or by email - Tualatin: Legacy Meridian Park Hospital
Contact: 503-413-1742
- Lancaster: Lancaster General, Ann B Barshinger Cancer Institute
Contact: Site Public Contact 717-544-0511 - Paoli: Paoli Memorial Hospital
Contact: 484-476-2649 or by email - Philadelphia: University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact 800-474-9892 - Philadelphia: Pennsylvania Hospital
Contact: 800-789-7366 - Philadelphia: Thomas Jefferson University Hospital
Contact: 215-955-6084 - West Chester: Chester County Hospital
Contact: Site Public Contact 610-431-5297
Willow Grove: Abington Memorial Hospital-Asplundh Cancer Pavilion
Contact: 215-481-2402 - Wynnewood: Lankenau Medical Center
Contact: 484-476-2649 or by email
- Providence: Women and Infants Hospital
Contact: 401-274-1122
- Sioux Falls: Sanford Cancer Center Oncology Clinic
Contact: 605-312-3320 or by email - Sioux Falls: Sanford USD Medical Center - Sioux Falls
Contact: 605-312-3320 or by email
- Dallas: Parkland Memorial Hospital
Contact: 214-590-5582 or by email - Dallas:UT Southwestern/Simmons Cancer Center-Dallas
Contact: 214-648-7097 or by email - Houston: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Contact: 713-798-1354 or by email - Houston: Houston Methodist Hospital
Contact: 713-790-2700 - Houston: Methodist Willowbrook Hospital
Contact: 412-339-5294 or by email - Sugar Land: Houston Methodist Sugar Land Hospital
Contact: Site Public Contact 281-242-2873
- Farmington: Farmington Health Center
Contact: 888-424-2100 or by email - Salt Lake City: University of Utah Sugarhouse Health Center
Contact: 888-424-2100 or by email - Salt Lake City: Huntsman Cancer Institute/University of Utah
Contact: 888-424-2100 or by email
- Richmond: VCU Massey Cancer Center at Stony Point
Contact: 804-628-1939 or by email - Richmond: Virginia Commonwealth University/Massey Cancer Center
Contact: 804-628-1914 or by email
- Vancouver: Legacy Salmon Creek Hospital
Contact: 503-413-2150
- Charleston: West Virginia University Charleston Division
Contact: 304-388-9944
- Brookfield: Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Contact: 414-635-6420 or by email - Eau Claire: Marshfield Medical Center-EC Cancer Center
Contact: 800-782-8581 or by email - Franklin: Ascension Saint Francis - Reiman Cancer Center
Contact: 800-782-8581 or by email - Franklin: Ascension Southeast Wisconsin Hospital - Franklin
Contact: 800-782-8581 or by email - La Crosse: Gundersen Lutheran Medical Center
Contact: 608-775-2385 or by email - Madison: University of Wisconsin Hospital and Clinics
Contact: Site Public Contact 800-622-8922 - Mequon: Ascension Columbia Saint Mary's Hospital Ozaukee
Contact: 414-635-6420 or by email - Milwaukee: Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Contact: 414-635-6420 or by email - Milwaukee: Ascension Columbia Saint Mary's Hospital - Milwaukee
Contact: 414-635-6420 or by email - Milwaukee: Ascension Saint Francis Hospital
Contact: 414-635-6420 or by email - Milwaukee: Medical College of Wisconsin
Contact: 414-805-3666 - Racine: Ascension All Saints Hospital
Contact: 414-635-6420 or by email - Stevens Point: Marshfield Clinic Stevens Point Center
Contact: 800-782-8581 or by email - Wauwatosa: Ascension Medical Group Southeast Wisconsin - Mayfair Road
Contact: 414-635-6420 or by email - Weston: Marshfield Medical Center - Weston
Contact: 800-782-8581 or by email
This Study is Open To:
Women, age 18 years or older, are eligible if they have:
Stage I endometrial cancer and a combination of age and risk factors as listed below:
- Age >= 70 and >= 1 risk factor
- Age 50 - < 70 and 2 risks factors
- Age < 50 and 3 risk factors
- Risk factors:
- Myometrial invasion >= 50%
- Lymphovascular space invasion
- Grade 2 or 3 tumor OR
Or
Stage II endometrial cancer
- Imaging showing no evidence of disease outside of the uterus
- Tumor shows mismatch repair deficiency (dMMR) and/or microsatellite instability high (MSI-high)
- Undergone surgical staging with at least hysterectomy, removal of cervix, bilateral salpingo-oophorectomy, and either sentinel lymph node assessment or complete pelvic +/- aortic lymphadenectomy.
- Received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy
This Study is Not Open To:
- Participated in or are currently receiving cancer-directed study therapy for endometrial cancer (4-week washout period prior to study registration is required)
- Received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents
- A history of autoimmune disease that might recur and require immune suppressive treatment. (Contact the study team to review a list of exceptions).
- A history of (non-infectious) pneumonitis requiring steroids
- A diagnosis of immunodeficiency or are receiving immunosuppressive therapy (Contact the study team to review a list of exceptions).
- Significant liver disease
- Uncontrolled other illness that might interfere with endometrial cancer diagnosis including, but not limited to: infections, lung disease, significant cardiac disease, or psychiatric illness