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Pembrolizumab Plus Lenvatinib Versus Chemotherapy for Endometrial Cancer
Clinicaltrials.gov identifier:
NCT03884101
Treatment:
Endometrial
Study Contact Information:
For additional information, please contact: 1-888-577-8839 or Trialsites@merck.com
Pembrolizumab Plus Lenvatinib Versus Chemotherapy for Endometrial Cancer
About the Study
The purpose of this study is to compare the effectiveness of using a combination of the immunotherapy drug pembrolizumab (Keytruda) and the targeted therapy lenvatinib (Lenvima) in women with Stage III, IV, or recurrent endometrial cancer versus using chemotherapy treatment alone.
Type of Study
This is a 2-arm, randomized, open-label, phase 3 study.
- The study has two arms, which means patients will be placed into one of two groups.
- Patients assigned to Group 1 will receive will receive lenvatinib and pembrolizumab
- Patients assigned to Group 2 will receive the chemotherapy drugs paclitaxeland carboplatin
- 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 participants will take lenvatinib daily (orally) and will receive pembrolizumab intravenously once at the start of each 3-week treatment cycle.
- Group 2 participants will receive chemotherapy medications paclitaxel intravenously and carboplatin intravenously on Day 1 of each 3-week treatment cycle.
Follow up
- Progression-free survival (the length of time that a patient survives without progression of the disease) of patients in this study will be measured for up to approximately 31 months.
- Overall survival of patients will be followed for up to approximately 45 months.
Study Sites
| Alabama | Arizona | California | Colorado | Connecticut |
| Georgia | Louisiana | Maine | Minnesota | New Jersey |
| New York | North Carolina | North Dakota | Oregon | South Dakota |
| Texas | Washington |
- Mobile: University of South Alabama, Mitchell Cancer Institute
Contact: 251-445-9834
- Tucson: Arizona Oncology Associates PC- HOPE
Contact: 281-863-6507
- Los Angeles: UCLA Hematology and Oncology Clinic (Westwood)
Contact: 310-794-6982
- Aurora: University of Colorado Cancer Center
Contact: 303-724-2066
- New Haven: Smilow Cancer Hospital at Yale New Haven
Contact: 203-785-6398
- Augusta: Georgia Cancer Center at Augusta University
Contact: 706-721-4805
- Covington: Women's Cancer Care
Contact: 985-892-2252
- Scarborough: Maine Medical Partners
Contact: 207-396-8376
- Minneapolis: Minnesota Oncology Hematology, PA
Contact: 281-863-6507
- Basking Ridge: Memorial Sloan-Kettering Cancer Center At Basking Ridge
Contact: 646-888-4224 - Hackensack: John Theurer Cancer Center at Hackensack University Med Ctr
Contact: 551-996-4716 - Middletown: Memorial Sloan Kettering Cancer Center- Monmouth
Contact: 646-888-4466 - Montvale: MSKCC-Bergen
Contact: 646-888-4466 - Teaneck: Holy Name Medical Center
Contact: 201-227-6200
- Commack: Memorial Sloan-Kettering Cancer Center at Commack
Contact: 646-888-4466 - Harrison: Memorial Sloan Kettering Cancer Center - West Harrison
Contact: 646-888-4424 - New York City:The Blavatnik Family- Chelsea Medical Center at Mount Sinai
Contact: 212-604-6059 - New York City: Memorial Sloan Kettering Cancer Center
Contact: 646-888-4224 - Rochester: University of Rochester
Contact: 585-275-5345 - Uniondale: Memorial Sloan Kettering Cancer Center - Nassau
Contact: 646-888-4466
- Chapel Hill: University of North Carolina- Chapel Hill
Contact: 919-966-4432
- Fargo: Roger Maris Cancer Center
Contact: 605-312-3250
- Eugene: Willamette Valley Cancer Institute and Research Center
Contact: 281-863-6507
- Sioux Falls: Sanford Cancer Center Oncology Clinic
Contact: 605-312-3343
- Dallas: Parkland Health & Hospital System
Contact: 214-648-7097 - Dallas: University of Texas Southwestern Medical Center
Contact: 214-648-3026 - The Woodlands: Texas Oncology-The Woodlands
Contact: 281-863-6507
- Vancouver: Legacy Salmon Creek Medical Center
Contact: 503-413-8654
This Study is Open To:
Women, age 18 years or older, are eligible if they:
- Have Stage III, Stage IV, or recurrent endometrial cancer
- Have provided tumor tissue sample or newly obtained biopsy of a tumor lesion that was not previously irradiated
- Are not pregnant or breastfeeding
- Have adequate organ function
This Study is Not Open To:
Women with the following are not eligible:
- Received prior systemic chemotherapy for the treatment of endometrial cancer
- Spread to the brain or spinal cord (central nervous system metastasis)
- Another cancer that has gotten worse or has required active treatment in the last 3 years
- Any of the following types of endometrial cancer:
- carcinosarcoma or malignant mixed Műllerian tumor, endometrial leiomyosarcoma or other high-grade sarcomas, or endometrial stromal sarcomas
- Significant heart disease
- History of HIV, Hepatitis B or Hepatitis C, or active tuberculosis
- History of (non-infectious) inflammation of lung tissue (pneumonitis)
- Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years