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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06132958




Registration number
NCT06132958
Ethics application status
Date submitted
10/11/2023
Date registered
15/11/2023

Titles & IDs
Public title
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
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)
Secondary ID [1] 0 0
2023-504816-14
Secondary ID [2] 0 0
2870-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 4 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs)
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Intervention Due to an AE
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
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])
Timepoint [5] 0 0
Baseline, up to approximately 4 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/01/2028
Actual
Sample size
Target
710
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GenesisCare North Shore ( Site 1103) - St Leonards
Recruitment hospital [2] 0 0
Blacktown Hospital ( Site 1101) - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital ( Site 1102) - Brisbane
Recruitment hospital [4] 0 0
Epworth Freemasons ( Site 1104) - East Melbourne
Recruitment hospital [5] 0 0
Frankston Hospital ( Site 1105) - Frankston
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2148 - Sydney
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Tirol
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Namur
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Ponce
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San Juan
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Singapore
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Central Singapore
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Gerona
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Spain
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Madrid, Comunidad De
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Spain
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Valenciana, Comunitat
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Skane Lan
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Sweden
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Stockholms Lan
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Basel-Stadt
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Switzerland
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Grisons
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Switzerland
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Ticino
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Switzerland
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Berne
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United Kingdom
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Brighton And Hove
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England
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United Kingdom
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London, City Of
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United Kingdom
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Sutton
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Network for Gynaecological Oncological Trial groups(ENGOT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
GOG Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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/NCT06132958