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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06132958
Registration number
NCT06132958
Ethics application status
Date submitted
10/11/2023
Date registered
15/11/2023
Date last updated
10/06/2024
Titles & IDs
Public title
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
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Scientific title
A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
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Secondary ID [1]
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2023-504816-14
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Secondary ID [2]
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2870-005
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Universal Trial Number (UTN)
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Trial acronym
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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
Other interventions - Sacituzumab tirumotecan
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel
Experimental: Sacituzumab tirumotecan - Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle. Additionally, participants receive diphenhydramine (or equivalent), a Histamine (H2 antagonist) of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Active Comparator: Chemotherapy - Participants will receive 60 mg/m^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Other interventions: Sacituzumab tirumotecan
4 mg/kg of sacituzumab tirumotecan by IV infusion
Treatment: Drugs: Doxorubicin
60 mg/m^2 of doxorubicin by IV Infusion
Treatment: Drugs: Paclitaxel
80 mg/m^2 of paclitaxel by IV infusion
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Intervention code [1]
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Other interventions
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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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Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to approximately 4 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 4 years
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Secondary outcome [1]
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Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
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Assessment method [1]
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ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR.
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Timepoint [1]
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Up to approximately 4 years
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Secondary outcome [2]
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Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
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Assessment method [2]
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For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
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Timepoint [2]
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Up to approximately 4 years
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Secondary outcome [3]
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Number of Participants Who Experience One or More Adverse Events (AEs)
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Assessment method [3]
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An AE is defined as 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 4 years
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Secondary outcome [4]
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Number of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [4]
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An AE is defined as 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 [4]
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Up to approximately 4 years
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Secondary outcome [5]
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Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])
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Assessment method [5]
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The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" 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 and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
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Timepoint [5]
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Baseline, up to approximately 4 years
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
- Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Has radiographically evaluable disease, either measurable or nonmeasurable per
response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded
independent central review (BICR).
- Has received prior platinum-based chemotherapy and anti-programmed cell death 1
protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately
or in combination.
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Minimum age
18
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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
- Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma,
leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease
and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease.
- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days
after completing platinum-based therapy administered in the curative-intent or
adjuvant setting without any additional platinum-based therapy received in the
metastatic or recurrent setting.
- Has received more than 3 prior lines of therapy for endometrial carcinoma or
carcinosarcoma.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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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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
6/12/2023
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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
10/01/2028
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Actual
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Sample size
Target
710
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Blacktown Hospital ( Site 1101) - Blacktown
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GenesisCare North Shore ( Site 1103) - St Leonards
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Royal Brisbane and Women's Hospital ( Site 1102) - Brisbane
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Epworth Freemasons ( Site 1104) - East Melbourne
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Frankston Hospital ( Site 1105) - Frankston
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2148 - Blacktown
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2065 - St Leonards
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4029 - Brisbane
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3002 - East Melbourne
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3199 - Frankston
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Sutton
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Manchester
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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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European Network for Gynaecological Oncological Trial groups(ENGOT)
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GOG Foundation
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Ethics approval
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Summary
Brief summary
The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of
Physician's Choice (TPC) with respect to progression-free survival (PFS) per response
evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central
review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab
tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and
that sacituzumab tirumotecan is superior to TPC with respect to OS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06132958
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Trial related presentations / publications
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Toll Free Number
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1-888-577-8839
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06132958
Download to PDF