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

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

ArmDescriptionAssigned 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).
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • KEYTRUDA®
    • MK-3475
    • SCH 900475
  • Drug: Carboplatin
    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.
  • Drug: Paclitaxel
    During the Induction Phase, participants receive paclitaxel 175 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Drug: Docetaxel
    During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Biological: Sacituzumab Tirumotecan
    IV Infusion
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264
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).
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • KEYTRUDA®
    • MK-3475
    • SCH 900475
  • Drug: Carboplatin
    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.
  • Drug: Paclitaxel
    During the Induction Phase, participants receive paclitaxel 175 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Drug: Docetaxel
    During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
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).
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • KEYTRUDA®
    • MK-3475
    • SCH 900475
  • Drug: Carboplatin
    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.
  • Drug: Paclitaxel
    During the Induction Phase, participants receive paclitaxel 175 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Drug: Docetaxel
    During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Biological: Sacituzumab Tirumotecan
    IV Infusion
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264
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.
  • Drug: Carboplatin
    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.
  • Drug: Paclitaxel
    During the Induction Phase, participants receive paclitaxel 175 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Drug: Docetaxel
    During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
  • Biological: Sacituzumab Tirumotecan
    IV Infusion
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264

Recruiting Locations

University of South Alabama, Mitchell Cancer Institute ( Site 6033)
Mobile 4076598, Alabama 4829764 36604
Contact:
Study Coordinator
251-665-8000

Alaska Women's Cancer Care ( Site 6036)
Anchorage 5879400, Alaska 5879092 99508
Contact:
Study Coordinator
907-562-4673

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
Orange 5379513, California 5332921 92868
Contact:
Study Coordinator
949-813-1517

Yale University School of Medicine ( Site 6009)
New Haven 4839366, Connecticut 4831725 06510
Contact:
Study Coordinator
203-737-4450

MedStar Washington Hospital Center ( Site 5005)
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Study Coordinator
202-877-7000

Florida Cancer Specialists - South ( Site 7003)
Fort Myers 4155995, Florida 4155751 33901
Contact:
Study Coordinator
239-274-9930

UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)
Gainesville 4156404, Florida 4155751 32608
Contact:
Study Coordinator
352-273-7832

Mount Sinai Cancer Center ( Site 6031)
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
305-674-2625

Florida Cancer Specialists ( Site 7002)
St. Petersburg 4171563, Florida 4155751 33701
Contact:
Study Coordinator
727-522-0558

Florida Cancer Specialists East ( Site 7001)
West Palm Beach 4177887, Florida 4155751 33401
Contact:
Study Coordinator
561-366-4100

St. Joseph's/Candler Health System ( Site 6021)
Savannah 4221552, Georgia 4197000 31405
Contact:
Study Coordinator
912-819-5704

University of Chicago Medical Center ( Site 5002)
Chicago 4887398, Illinois 4896861 60637
Contact:
Study Coordinator
773-702-1220

Parkview Research Center ( Site 6008)
Fort Wayne 4920423, Indiana 4921868 46845
Contact:
Study Coordinator
800-724-8326

Women's Cancer Care ( Site 6010)
Covington 4321005, Louisiana 4331987 70433
Contact:
Study Coordinator
985-317-6005

TRIALS 365 ( Site 6005)
Shreveport 4341513, Louisiana 4331987 71103
Contact:
Study Coordinator
318-408-1198

Maine Medical Center - Scarborough Campus ( Site 6042)
Scarborough 4977882, Maine 4971068 04074
Contact:
Study Coordinator
207-396-7089

Minnesota Oncology Hematology, PA ( Site 8003)
Minneapolis 5037649, Minnesota 5037779 55404
Contact:
Study Coordinator
817-837-8660

St. Dominic's Hospital ( Site 5004)
Jackson 4431410, Mississippi 4436296 39216
Contact:
Study Coordinator
601-200-4970

Holy Name Medical Center ( Site 6011)
Teaneck 5105262, New Jersey 5101760 07666
Contact:
Study Coordinator
201-227-6200

University of New Mexico Comprehensive Cancer Center ( Site 6046)
Albuquerque 5454711, New Mexico 5481136 87131
Contact:
Study Coordinator
505-272-4946

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)
Mineola 5127134, New York 5128638 11501
Contact:
Study Coordinator
516-708-4821

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)
New York 5128581, New York 5128638 10016
Contact:
Study Coordinator
212-731-6455

Duke Cancer Institute ( Site 6049)
Durham 4464368, North Carolina 4482348 27710
Contact:
Study Coordinator
919-684-3780

FirstHealth of the Carolinas ( Site 6037)
Pinehurst 4485272, North Carolina 4482348 28374
Contact:
Study Coordinator
910-715-8684

Miami Valley Hospital South ( Site 6014)
Centerville 4508204, Ohio 5165418 45459
Contact:
Study Coordinator
937-438-7800

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)
Tulsa 4553433, Oklahoma 4544379 74146
Contact:
Study Coordinator
918-505-3200

St. Luke's University Health Network ( Site 6041)
Bethlehem 5180225, Pennsylvania 6254927 18015
Contact:
Study Coordinator
484-503-4673

Hospital of the University of Pennsylvania ( Site 5007)
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Study Coordinator
215-662-2487

AHN West Penn Hospital ( Site 6006)
Pittsburgh 5206379, Pennsylvania 6254927 15224
Contact:
Study Coordinator
412-578-1116

Women & Infants Hospital ( Site 5003)
Providence 5224151, Rhode Island 5224323 02905
Contact:
Study Coordinator
401-453-7520

Texas Oncology - DFW ( Site 8004)
Fort Worth 4691930, Texas 4736286 76104
Contact:
Study Coordinator
817-413-1500

Texas Oncology-San Antonio Medical Center ( Site 8001)
San Antonio 4726206, Texas 4736286 78240
Contact:
Study Coordinator
210-595-5300

Texas Oncology - Northeast Texas ( Site 8002)
Tyler 4738214, Texas 4736286 75702
Contact:
Study Coordinator
903-579-9800

Inova Schar Cancer Institute ( Site 6003)
Fairfax 4758023, Virginia 6254928 22031
Contact:
Study Coordinator
571-472-4724

VCU Health Adult Outpatient Pavillion ( Site 5000)
Richmond 4781708, Virginia 6254928 23219
Contact:
Study Coordinator
804-628-4368

Puerto Rico Cancer Specialists Clinical Trials ( Site 4201)
San Juan 4568127, Puerto Rico 00917
Contact:
Study Coordinator
+7879452919

More Details

NCT ID
NCT06952504
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.