A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
Purpose
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.
Condition
- Endometrial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
include but are not limited to: - Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR) - Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator. - Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
Exclusion Criteria
include but are not limited to: - Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas - Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR) - Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment - Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are allocated to a single induction arm, then assigned randomly to either one of two maintenance treatment arms or one of two subsequent treatment arms.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan |
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months). |
|
|
Active Comparator Maintenance Treatment Arm B: Pembrolizumab Monotherapy |
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months). |
|
|
Experimental Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan |
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months). |
|
|
Active Comparator Subsequent Treatment Arm B: Sacituzumab Tirumotecan Monotherapy |
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met. |
|
Recruiting Locations
Mobile 4076598, Alabama 4829764 36604
Study Coordinator
251-665-8000
Anchorage 5879400, Alaska 5879092 99508
Study Coordinator
907-562-4673
Orange 5379513, California 5332921 92868
Study Coordinator
949-813-1517
New Haven 4839366, Connecticut 4831725 06510
Study Coordinator
203-737-4450
Washington D.C. 4140963, District of Columbia 4138106 20010
Study Coordinator
202-877-7000
Fort Myers 4155995, Florida 4155751 33901
Study Coordinator
239-274-9930
Gainesville 4156404, Florida 4155751 32608
Study Coordinator
352-273-7832
Miami Beach 4164143, Florida 4155751 33140
Study Coordinator
305-674-2625
St. Petersburg 4171563, Florida 4155751 33701
Study Coordinator
727-522-0558
West Palm Beach 4177887, Florida 4155751 33401
Study Coordinator
561-366-4100
Savannah 4221552, Georgia 4197000 31405
Study Coordinator
912-819-5704
Chicago 4887398, Illinois 4896861 60637
Study Coordinator
773-702-1220
Fort Wayne 4920423, Indiana 4921868 46845
Study Coordinator
800-724-8326
Covington 4321005, Louisiana 4331987 70433
Study Coordinator
985-317-6005
Shreveport 4341513, Louisiana 4331987 71103
Study Coordinator
318-408-1198
Scarborough 4977882, Maine 4971068 04074
Study Coordinator
207-396-7089
Minneapolis 5037649, Minnesota 5037779 55404
Study Coordinator
817-837-8660
Jackson 4431410, Mississippi 4436296 39216
Study Coordinator
601-200-4970
Teaneck 5105262, New Jersey 5101760 07666
Study Coordinator
201-227-6200
Albuquerque 5454711, New Mexico 5481136 87131
Study Coordinator
505-272-4946
Mineola 5127134, New York 5128638 11501
Study Coordinator
516-708-4821
New York 5128581, New York 5128638 10016
Study Coordinator
212-731-6455
Durham 4464368, North Carolina 4482348 27710
Study Coordinator
919-684-3780
Pinehurst 4485272, North Carolina 4482348 28374
Study Coordinator
910-715-8684
Centerville 4508204, Ohio 5165418 45459
Study Coordinator
937-438-7800
Tulsa 4553433, Oklahoma 4544379 74146
Study Coordinator
918-505-3200
Bethlehem 5180225, Pennsylvania 6254927 18015
Study Coordinator
484-503-4673
Philadelphia 4560349, Pennsylvania 6254927 19104
Study Coordinator
215-662-2487
Pittsburgh 5206379, Pennsylvania 6254927 15224
Study Coordinator
412-578-1116
Providence 5224151, Rhode Island 5224323 02905
Study Coordinator
401-453-7520
Fort Worth 4691930, Texas 4736286 76104
Study Coordinator
817-413-1500
San Antonio 4726206, Texas 4736286 78240
Study Coordinator
210-595-5300
Tyler 4738214, Texas 4736286 75702
Study Coordinator
903-579-9800
Fairfax 4758023, Virginia 6254928 22031
Study Coordinator
571-472-4724
Richmond 4781708, Virginia 6254928 23219
Study Coordinator
804-628-4368
San Juan 4568127, Puerto Rico 00917
Study Coordinator
+7879452919
More Details
- NCT ID
- NCT06952504
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
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.