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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
TroFuse-005
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 >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
* Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
* Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
* Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
* Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer

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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Central Singapore
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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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Stockholms Lan
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Sutton
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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
Trialsites@msd.com
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