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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06952504
Registration number
NCT06952504
Ethics application status
Date submitted
23/04/2025
Date registered
1/05/2025
Date last updated
11/09/2025
Titles & IDs
Public 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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Scientific 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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Secondary ID [1]
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2024-519331-42-00
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Secondary ID [2]
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2870-033
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Universal Trial Number (UTN)
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Trial acronym
TroFuse-033
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Docetaxel
Treatment: Other - Sacituzumab Tirumotecan
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.
Treatment: Other: Pembrolizumab
Intravenous (IV) Infusion
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Other: Sacituzumab Tirumotecan
IV Infusion
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maintenance Treatment: Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 44 months
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Primary outcome [2]
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Maintenance Treatment: Overall Survival (OS)
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Assessment method [2]
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OS is defined as time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 54 months
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Secondary outcome [1]
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Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 54 months
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Secondary outcome [2]
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Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 27 months
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Secondary outcome [3]
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Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 24 months
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Secondary outcome [4]
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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 (Item 29) and Quality of Life (Item 30) Item Mean Score
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Assessment method [4]
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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 Items 29 and 30 mean score will be presented.
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Timepoint [4]
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Baseline and up to approximately 24 months
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Secondary outcome [5]
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Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and up to approximately 24 months
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Secondary outcome [6]
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Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and up to approximately 24 months
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Secondary outcome [7]
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Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)
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Assessment method [7]
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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 indicates a better quality of life. The change from baseline in EORTC QLQ-E24 back and pelvis pain score will be presented.
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Timepoint [7]
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Baseline and up to approximately 24 months
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Eligibility
Key inclusion criteria
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 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/05/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/05/2032
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Actual
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Sample size
Target
1123
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Blacktown Hospital ( Site 0201) - Blacktown
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Recruitment hospital [2]
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Epworth Freemasons ( Site 0207) - Melbourne
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2148 - Blacktown
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Recruitment postcode(s) [2]
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3002 - Melbourne
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Recruitment outside Australia
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Florida
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Louisiana
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CABA
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Taegu-Kwangyokshi
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Seoul
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Barcelona
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Gerona
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Madrid
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Taichung
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Taiwan
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Tainan City
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Taipei
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Taiwan
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Taoyuan District
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United Kingdom
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Brighton And Hove
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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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Trial website
https://clinicaltrials.gov/study/NCT06952504
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Phone
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1-888-577-8839
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://externaldatasharing-msd.com/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06952504
Download to PDF