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)

NCT06952504
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,123
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2025-05-22
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Number of sites
262
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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.
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Acronym
TroFuse-033
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Short title
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)
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Official title
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-05-24
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First posted
2025-05-01
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Registry last updated
2026-08-28
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Primary completion date
2032-05-24
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Start date
2025-05-22
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Participants
1,123
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Participant count basis
Estimated
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Planned participants
1,123
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Protocol amendments
3
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Number of sites
262
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06952504
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ClinicalTrials.gov ID
NCT06952504
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Maintenance Treatment: Progression-Free Survival (PFS)

    Timeframe: Up to approximately 44 months

    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.

  2. Maintenance Treatment: Overall Survival (OS)

    Timeframe: Up to approximately 54 months

    OS is defined as time from randomization to death due to any cause.

  1. Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator

    Timeframe: Up to approximately 54 months

    PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. PFS2 as assessed by the investigator will be presented.

  2. Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)

    Timeframe: Up to approximately 27 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE

    Timeframe: Up to approximately 24 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  4. 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

    Timeframe: Baseline and up to approximately 24 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score (Items 29 and 30) will be presented.

  5. Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    Timeframe: Baseline and up to approximately 24 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score will be presented.

  6. Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    Timeframe: Baseline and up to approximately 24 months

    EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be presented.

  7. Maintenance Treatment: Change from baseline in EORTC QLQ-EN24 Symptom Score

    Timeframe: Baseline and up to approximately 24 months

    The EORTC QLQ-EN24 is a 24-item questionnaire developed to be used in conjunction with the EORTC-QLQ-C30 to assess the quality of life of endometrial cancer patients. Participant responses are scored on a 4-point scale (1=not at all to 4=very much). A higher score reflects greater symptom severity. The change from baseline in EORTC QLQ-EN24 back and pelvis pain score will be presented.

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key 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

Key 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 debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following 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
Sources for eligibility
clinicaltrials.gov

  • University of South Alabama, Mitchell Cancer Institute ( Site 6033)Mobile, United StatesRecruiting
  • Alaska Women's Cancer Care ( Site 6036)Anchorage, United StatesRecruiting
  • CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)Irvine, United StatesRecruiting
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)Orange, United StatesRecruiting
  • John Muir Health Cancer Center ( Site 6028)Walnut Creek, United StatesRecruiting
  • Yale University School of Medicine ( Site 6009)New Haven, United StatesRecruiting
  • MedStar Washington Hospital Center ( Site 5005)Washington D.C., United StatesRecruiting
  • Florida Cancer Specialists - South ( Site 7003)Fort Myers, United StatesRecruiting
  • UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)Gainesville, United StatesRecruiting
  • Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)Miami Beach, United StatesRecruiting
  • AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)Orlando, United StatesRecruiting
  • Florida Cancer Specialists ( Site 7002)St. Petersburg, United StatesRecruiting
  • Florida Cancer Specialists East ( Site 7001)West Palm Beach, United StatesRecruiting
  • St. Joseph's/Candler Health System ( Site 6021)Savannah, United StatesRecruiting
  • University of Chicago Medical Center ( Site 5002)Chicago, United StatesRecruiting
  • Parkview Research Center ( Site 6008)Fort Wayne, United StatesRecruiting
  • Women's Cancer Care ( Site 6010)Covington, United StatesRecruiting
  • TRIALS 365 ( Site 6005)Shreveport, United StatesRecruiting
  • Maine Medical Center - Scarborough Campus ( Site 6042)Scarborough, United StatesRecruiting
  • Tufts Medical Center ( Site 6052)Boston, United StatesRecruiting
  • Minnesota Oncology Hematology, PA ( Site 8003)Minneapolis, United StatesRecruiting
  • St. Dominic's Hospital ( Site 5004)Jackson, United StatesRecruiting
  • Holy Name Medical Center ( Site 6011)Teaneck, United StatesRecruiting
  • University of New Mexico Comprehensive Cancer Center ( Site 6046)Albuquerque, United StatesRecruiting
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)Mineola, United StatesRecruiting

And 237 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • TroFuse-033
  • U1111-1315-0794
  • 2024-519331-42-00
  • GOG-3119
  • jRCT2011250020
  • ENGOT-en29
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (1)

Targets (16)