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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06459180




Registration number
NCT06459180
Ethics application status
Date submitted
10/06/2024
Date registered
14/06/2024

Titles & IDs
Public title
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
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 as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)
Secondary ID [1] 0 0
MK-2870-020
Secondary ID [2] 0 0
2870-020
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sacituzumab Tirumotecan
Treatment: Drugs - Pemetrexed
Treatment: Other - Tisotumab Vedotin
Treatment: Drugs - Topotecan
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Irinotecan

Experimental: Sacituzumab Tirumotecan - Participants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.

Active comparator: Treatment of Physician's Choice (TPC) - At the physician's discretion, participants will receive 2 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.


Treatment: Other: Sacituzumab Tirumotecan
IV infusion

Treatment: Drugs: Pemetrexed
IV infusion

Treatment: Other: Tisotumab Vedotin
IV infusion

Treatment: Drugs: Topotecan
IV infusion

Treatment: Drugs: Vinorelbine
IV infusion

Treatment: Drugs: Gemcitabine
IV infusion

Treatment: Drugs: Irinotecan
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
Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in
Timepoint [1] 0 0
Up to approximately 51 months
Primary outcome [2] 0 0
Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in
Timepoint [2] 0 0
Up to approximately 51 months
Primary outcome [3] 0 0
Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in
Timepoint [3] 0 0
Up to approximately 51 months
Primary outcome [4] 0 0
Overall Survival (OS) in Phase 3 Portion
Timepoint [4] 0 0
Up to approximately 43 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) in Phase 3 Portion
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [2] 0 0
ORR in Phase 3 Portion
Timepoint [2] 0 0
Up to approximately 43 months
Secondary outcome [3] 0 0
Duration of Response (DOR) in Phase 3 Portion
Timepoint [3] 0 0
Up to approximately 43 months
Secondary outcome [4] 0 0
Number of Participants Experiencing One or More AEs in Phase 3 Portion
Timepoint [4] 0 0
Up to approximately 51 months
Secondary outcome [5] 0 0
Number of Participants Discontinuing Study Treatment Due to an AE in Phase 3 Portion
Timepoint [5] 0 0
Up to approximately 51 months
Secondary outcome [6] 0 0
Time to First Deterioration (TTD) in European Organisation for 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) Combined Score in Phase 3 Portion
Timepoint [6] 0 0
Baseline and up to approximately 51 months
Secondary outcome [7] 0 0
Change from Baseline in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion
Timepoint [7] 0 0
Baseline and up to approximately 51 months
Secondary outcome [8] 0 0
Change from Baseline in EORTC QLQ-C30 Physical Functioning Score in Phase 3 Portion
Timepoint [8] 0 0
Baseline and up to approximately 51 months
Secondary outcome [9] 0 0
Change from Baseline in EORTC QLQ-C30 Role Functioning Score in Phase 3 Portion
Timepoint [9] 0 0
Baseline and up to approximately 51 months

Eligibility
Key inclusion criteria
* Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
* Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
* Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
* Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
* Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
* Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
* HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has Grade =2 peripheral neuropathy
* Has 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received prior systemic anticancer therapy
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has histologically-confirmed diagnosis of glassy cell carcinoma variant, adenoid cystic carcinoma, adenoid basal carcinoma, neuroendocrine tumors, carcinoid, atypical carcinoid, small-carcinoma, large-cell neuroendocrine carcinoma, or undifferentiated carcinoma
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Concurrent active Hepatitis B and active Hepatitis C virus infection
* Severe hypersensitivity (=Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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
24/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/10/2028
Actual
Sample size
Target
686
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital ( Site 3006) - Sydney
Recruitment hospital [2] 0 0
Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000) - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital ( Site 3001) - Herston
Recruitment hospital [4] 0 0
Monash Health-Oncology Research ( Site 3002) - Clayton
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005) - Melbourne
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital ( Site 3003) - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Sydney
Recruitment postcode(s) [2] 0 0
2560 - Sydney
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Caba
Country [7] 0 0
Argentina
State/province [7] 0 0
La Rioja
Country [8] 0 0
Belgium
State/province [8] 0 0
Namur
Country [9] 0 0
Chile
State/province [9] 0 0
Region M. De Santiago
Country [10] 0 0
Chile
State/province [10] 0 0
Valparaiso
Country [11] 0 0
Denmark
State/province [11] 0 0
Midtjylland
Country [12] 0 0
Denmark
State/province [12] 0 0
Syddanmark
Country [13] 0 0
Finland
State/province [13] 0 0
Pirkanmaa
Country [14] 0 0
Israel
State/province [14] 0 0
Haifa
Country [15] 0 0
Israel
State/province [15] 0 0
Holon
Country [16] 0 0
Israel
State/province [16] 0 0
Jerusalem
Country [17] 0 0
Italy
State/province [17] 0 0
Lazio
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Netherlands
State/province [20] 0 0
Gelderland
Country [21] 0 0
Netherlands
State/province [21] 0 0
Noord-Holland
Country [22] 0 0
Netherlands
State/province [22] 0 0
Zuid-Holland
Country [23] 0 0
Norway
State/province [23] 0 0
Oslo
Country [24] 0 0
Puerto Rico
State/province [24] 0 0
San Juan
Country [25] 0 0
Spain
State/province [25] 0 0
Cataluna
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid, Comunidad De
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Sweden
State/province [28] 0 0
Uppsala Lan
Country [29] 0 0
Switzerland
State/province [29] 0 0
Basel-Stadt
Country [30] 0 0
Switzerland
State/province [30] 0 0
Berne

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 of 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/NCT06459180