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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
Date last updated
25/11/2024

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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Argentina
State/province [10] 0 0
La Rioja
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Belgium
State/province [12] 0 0
Oost-Vlaanderen
Country [13] 0 0
Belgium
State/province [13] 0 0
Vlaams-Brabant
Country [14] 0 0
Belgium
State/province [14] 0 0
Namur
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Plovdiv
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Region M. De Santiago
Country [19] 0 0
Chile
State/province [19] 0 0
Valparaiso
Country [20] 0 0
Colombia
State/province [20] 0 0
Cesar
Country [21] 0 0
Colombia
State/province [21] 0 0
Cordoba
Country [22] 0 0
Colombia
State/province [22] 0 0
Distrito Capital De Bogota
Country [23] 0 0
Colombia
State/province [23] 0 0
Risaralda
Country [24] 0 0
Colombia
State/province [24] 0 0
Valle Del Cauca
Country [25] 0 0
Denmark
State/province [25] 0 0
Midtjylland
Country [26] 0 0
Denmark
State/province [26] 0 0
Syddanmark
Country [27] 0 0
Finland
State/province [27] 0 0
Pirkanmaa
Country [28] 0 0
Finland
State/province [28] 0 0
Uusimaa
Country [29] 0 0
France
State/province [29] 0 0
Auvergne
Country [30] 0 0
France
State/province [30] 0 0
Ile-de-France
Country [31] 0 0
Greece
State/province [31] 0 0
Peloponnisos
Country [32] 0 0
Ireland
State/province [32] 0 0
Dublin
Country [33] 0 0
Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Holon
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Italy
State/province [36] 0 0
Emilia-Romagna
Country [37] 0 0
Italy
State/province [37] 0 0
Lazio
Country [38] 0 0
Italy
State/province [38] 0 0
Lombardia
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Italy
State/province [40] 0 0
Napoli
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Japan
State/province [41] 0 0
Ehime
Country [42] 0 0
Japan
State/province [42] 0 0
Fukuoka
Country [43] 0 0
Japan
State/province [43] 0 0
Gunma
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaido
Country [45] 0 0
Japan
State/province [45] 0 0
Saitama
Country [46] 0 0
Japan
State/province [46] 0 0
Tokyo
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
Malaysia
State/province [48] 0 0
Kuala Lumpur
Country [49] 0 0
Netherlands
State/province [49] 0 0
Gelderland
Country [50] 0 0
Netherlands
State/province [50] 0 0
Noord-Brabant
Country [51] 0 0
Netherlands
State/province [51] 0 0
Noord-Holland
Country [52] 0 0
Netherlands
State/province [52] 0 0
Zuid-Holland
Country [53] 0 0
Netherlands
State/province [53] 0 0
Groningen
Country [54] 0 0
Norway
State/province [54] 0 0
Oslo
Country [55] 0 0
Poland
State/province [55] 0 0
Mazowieckie
Country [56] 0 0
Poland
State/province [56] 0 0
Podlaskie
Country [57] 0 0
Puerto Rico
State/province [57] 0 0
San Juan
Country [58] 0 0
Singapore
State/province [58] 0 0
Central Singapore
Country [59] 0 0
Spain
State/province [59] 0 0
Cataluna
Country [60] 0 0
Spain
State/province [60] 0 0
Gerona
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid, Comunidad De
Country [62] 0 0
Spain
State/province [62] 0 0
Valenciana, Comunitat
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Cordoba
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Sweden
State/province [66] 0 0
Skane Lan
Country [67] 0 0
Sweden
State/province [67] 0 0
Stockholms Lan
Country [68] 0 0
Sweden
State/province [68] 0 0
Uppsala Lan
Country [69] 0 0
Switzerland
State/province [69] 0 0
Basel-Stadt
Country [70] 0 0
Switzerland
State/province [70] 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
This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
Trial website
https://clinicaltrials.gov/study/NCT06459180
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06459180