A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
Summary
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
Detailed description
All participants undergo an initial Induction Phase of six cycles, each cycle consisting of pembrolizumab + carboplatin + paclitaxel or docetaxel. Each cycle is three weeks. Participants whose cancer does not progress enter the Maintenance Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or pembrolizumab monotherapy. Participants whose cancer does progress will have the possibility to enter the Subsequent Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or sac-TMT monotherapy.
Arms & interventions
- BiologicalPembrolizumab
Intravenous (IV) Infusion
- DrugCarboplatin
During the Induction Phase, participants receive carboplatin AUC 5 (mg/mL/min) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
- DrugPaclitaxel
During the Induction Phase, participants receive paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
- DrugDocetaxel
During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
- BiologicalSacituzumab Tirumotecan
IV Infusion
Outcome measures
Primary
Maintenance Treatment: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as evaluated by the blinded independent central review (BICR). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Time frame: Up to approximately 44 months
Maintenance Treatment: Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Time frame: Up to approximately 54 months
Secondary
Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator
Time frame: Up to approximately 54 months
Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 27 months
Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 24 months
Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Mean Score
Time frame: Baseline and up to approximately 24 months
Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time frame: Baseline and up to approximately 24 months
Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time frame: Baseline and up to approximately 24 months
Maintenance Treatment: Change from baseline in EORTC QLQ-EN24 Symptom Score
Time frame: Baseline and up to approximately 24 months
Eligibility criteria
Study locations (44)
University of South Alabama, Mitchell Cancer Institute ( Site 6033)
Mobile, Alabama, 36604
Alaska Women's Cancer Care ( Site 6036)
Anchorage, Alaska, 99508
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
Orange, California, 92868
John Muir Health Cancer Center ( Site 6028)
Walnut Creek, California, 94598
Yale University School of Medicine ( Site 6009)
New Haven, Connecticut, 06510
MedStar Washington Hospital Center ( Site 5005)
Washington D.C., District of Columbia, 20010
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, 33901
UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)
Gainesville, Florida, 32608
Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)
Miami Beach, Florida, 33140
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)
Orlando, Florida, 32804
Florida Cancer Specialists ( Site 7002)
St. Petersburg, Florida, 33701
Florida Cancer Specialists East ( Site 7001)
West Palm Beach, Florida, 33401
St. Joseph's/Candler Health System ( Site 6021)
Savannah, Georgia, 31405
University of Chicago Medical Center ( Site 5002)
Chicago, Illinois, 60637
Parkview Research Center ( Site 6008)
Fort Wayne, Indiana, 46845
Women's Cancer Care ( Site 6010)
Covington, Louisiana, 70433
TRIALS 365 ( Site 6005)
Shreveport, Louisiana, 71103
Maine Medical Center - Scarborough Campus ( Site 6042)
Scarborough, Maine, 04074
Tufts Medical Center ( Site 6052)
Boston, Massachusetts, 02111
Minnesota Oncology Hematology, PA ( Site 8003)
Minneapolis, Minnesota, 55404
St. Dominic's Hospital ( Site 5004)
Jackson, Mississippi, 39216
Holy Name Medical Center ( Site 6011)
Teaneck, New Jersey, 07666
University of New Mexico Comprehensive Cancer Center ( Site 6046)
Albuquerque, New Mexico, 87131
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)
New York, New York, 10016
Duke Cancer Institute ( Site 6049)
Durham, North Carolina, 27710
FirstHealth of the Carolinas ( Site 6037)
Pinehurst, North Carolina, 28374
Miami Valley Hospital South ( Site 6014)
Centerville, Ohio, 45459
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, 43210
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)
Kettering, Ohio, 45429
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)
Tulsa, Oklahoma, 74146
Oncology Associates of Oregon, P.C. ( Site 8005)
Eugene, Oregon, 97401
St. Luke's University Health Network ( Site 6041)
Bethlehem, Pennsylvania, 18015
Hospital of the University of Pennsylvania ( Site 5007)
Philadelphia, Pennsylvania, 19104
Hospital of the University of Pennsylvania ( Site 6023)
Philadelphia, Pennsylvania, 19104
AHN West Penn Hospital ( Site 6006)
Pittsburgh, Pennsylvania, 15224
Women & Infants Hospital ( Site 5003)
Providence, Rhode Island, 02905
Texas Oncology - DFW ( Site 8004)
Fort Worth, Texas, 76104
Houston Methodist Hospital ( Site 6057)
Houston, Texas, 77030
Texas Oncology-San Antonio Medical Center ( Site 8001)
San Antonio, Texas, 78240
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, 75702
Texas Oncology - Gulf Coast ( Site 8006)
Webster, Texas, 77598
Inova Schar Cancer Institute ( Site 6003)
Fairfax, Virginia, 22031
VCU Health Adult Outpatient Pavillion ( Site 5000)
Richmond, Virginia, 23219