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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06312176




Registration number
NCT06312176
Ethics application status
Date submitted
7/03/2024
Date registered
15/03/2024
Date last updated
22/11/2024

Titles & IDs
Public title
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Scientific title
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
MK-2870-010
Secondary ID [2] 0 0
2870-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab tirumotecan
Treatment: Other - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Capecitabine
Treatment: Drugs - Liposomal doxorubicin

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

Experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan - Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).

Active comparator: Arm C: Treatment of Physician's Choice (TPC) - At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.


Treatment: Drugs: Sacituzumab tirumotecan
IV infusion

Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Paclitaxel
IV infusion

Treatment: Drugs: Nab-paclitaxel
IV infusion

Treatment: Drugs: Capecitabine
oral tablet

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
Timepoint [1] 0 0
Up to ~38 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~77 months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
Timepoint [2] 0 0
Up to ~57 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to ~57 months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Up to ~57 months
Secondary outcome [5] 0 0
Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [5] 0 0
Baseline and up to ~77 months
Secondary outcome [6] 0 0
Change from baseline in physical functioning score, on the EORTC QLQ-C30
Timepoint [6] 0 0
Baseline and up to ~77 months
Secondary outcome [7] 0 0
Change from baseline in emotional functioning score, on the EORTC QLQ-C30
Timepoint [7] 0 0
Baseline and up to ~77 months
Secondary outcome [8] 0 0
Change from baseline in fatigue score, on the EORTC QLQ-C30
Timepoint [8] 0 0
Baseline and up to ~77 months
Secondary outcome [9] 0 0
Change from baseline in diarrhea score, on the EORTC QLQ-C30
Timepoint [9] 0 0
Baseline and up to ~77 months
Secondary outcome [10] 0 0
Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
Timepoint [10] 0 0
Up to ~77 months
Secondary outcome [11] 0 0
TTD in physical functioning score, on the EORTC QLQ-C30
Timepoint [11] 0 0
Up to ~77 months
Secondary outcome [12] 0 0
TTD in emotional functioning score, on the EORTC QLQ-C30
Timepoint [12] 0 0
Up to ~77 months
Secondary outcome [13] 0 0
TTD in fatigue score, on the EORTC QLQ-C30
Timepoint [13] 0 0
Up to ~77 months
Secondary outcome [14] 0 0
TTD in diarrhea score, on the EORTC QLQ-C30
Timepoint [14] 0 0
Up to ~77 months
Secondary outcome [15] 0 0
Number of participants who experience one or more adverse events (AEs)
Timepoint [15] 0 0
Up to ~77 months
Secondary outcome [16] 0 0
Number of participants who discontinue study treatment due to an AE
Timepoint [16] 0 0
Up to ~77 months

Eligibility
Key inclusion criteria
* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has breast cancer amenable to treatment with curative intent
* Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
* Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy

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
14/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/04/2031
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 2002) - Macquarie University
Recruitment hospital [2] 0 0
Westmead Hospital-Westmead Breast Cancer Institute ( Site 2000) - Westmead
Recruitment hospital [3] 0 0
Frankston Hospital-Oncology and Haematology ( Site 2003) - Frankston
Recruitment hospital [4] 0 0
Fiona Stanley Hospital-Medical Oncology ( Site 2004) - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Caba
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
La Rioja
Country [15] 0 0
Belgium
State/province [15] 0 0
Oost-Vlaanderen
Country [16] 0 0
Belgium
State/province [16] 0 0
Namur
Country [17] 0 0
Brazil
State/province [17] 0 0
Piaui
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Chile
State/province [21] 0 0
Region M. De Santiago
Country [22] 0 0
Chile
State/province [22] 0 0
Antofagasta
Country [23] 0 0
Colombia
State/province [23] 0 0
Antioquia
Country [24] 0 0
Colombia
State/province [24] 0 0
Cesar
Country [25] 0 0
Colombia
State/province [25] 0 0
Cordoba
Country [26] 0 0
Colombia
State/province [26] 0 0
Distrito Capital De Bogota
Country [27] 0 0
Colombia
State/province [27] 0 0
Valle Del Cauca
Country [28] 0 0
Costa Rica
State/province [28] 0 0
San Jose
Country [29] 0 0
France
State/province [29] 0 0
Calvados
Country [30] 0 0
France
State/province [30] 0 0
Languedoc-Roussillon
Country [31] 0 0
France
State/province [31] 0 0
Loire-Atlantique
Country [32] 0 0
France
State/province [32] 0 0
Orne
Country [33] 0 0
France
State/province [33] 0 0
Rhone-Alpes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
Greece
State/province [35] 0 0
Attiki
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Greece
State/province [36] 0 0
Kentriki Makedonia
Country [37] 0 0
Greece
State/province [37] 0 0
Thessalia
Country [38] 0 0
Hong Kong
State/province [38] 0 0
Hksar
Country [39] 0 0
Hong Kong
State/province [39] 0 0
Shatin
Country [40] 0 0
Hungary
State/province [40] 0 0
Csongrad
Country [41] 0 0
Hungary
State/province [41] 0 0
Somogy
Country [42] 0 0
Hungary
State/province [42] 0 0
Zala
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Debrecen
Country [45] 0 0
Israel
State/province [45] 0 0
Haifa
Country [46] 0 0
Israel
State/province [46] 0 0
Jerusalem
Country [47] 0 0
Israel
State/province [47] 0 0
Petah Tikva
Country [48] 0 0
Israel
State/province [48] 0 0
Ramat Gan
Country [49] 0 0
Italy
State/province [49] 0 0
Friuli-Venezia Giulia
Country [50] 0 0
Italy
State/province [50] 0 0
Lombardia
Country [51] 0 0
Italy
State/province [51] 0 0
Milano
Country [52] 0 0
Italy
State/province [52] 0 0
Bologna
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Malaysia
State/province [55] 0 0
Johor
Country [56] 0 0
Malaysia
State/province [56] 0 0
Sarawak
Country [57] 0 0
Malaysia
State/province [57] 0 0
Kuala Lumpur
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Mexico
State/province [58] 0 0
Distrito Federal
Country [59] 0 0
Mexico
State/province [59] 0 0
Jalisco
Country [60] 0 0
Mexico
State/province [60] 0 0
Nuevo Leon
Country [61] 0 0
Netherlands
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Gelderland
Country [62] 0 0
Netherlands
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Limburg
Country [63] 0 0
Netherlands
State/province [63] 0 0
Noord-Brabant
Country [64] 0 0
Netherlands
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Noord-Holland
Country [65] 0 0
Netherlands
State/province [65] 0 0
Utrecht
Country [66] 0 0
New Zealand
State/province [66] 0 0
Auckland
Country [67] 0 0
Peru
State/province [67] 0 0
Ariqipa
Country [68] 0 0
Peru
State/province [68] 0 0
Lima
Country [69] 0 0
Peru
State/province [69] 0 0
Muni Metro De Lima
Country [70] 0 0
Poland
State/province [70] 0 0
Kujawsko-pomorskie
Country [71] 0 0
Poland
State/province [71] 0 0
Mazowieckie
Country [72] 0 0
Poland
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Podkarpackie
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Poland
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Podlaskie
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Poland
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Pomorskie
Country [75] 0 0
Poland
State/province [75] 0 0
Slaskie
Country [76] 0 0
Poland
State/province [76] 0 0
Swietokrzyskie
Country [77] 0 0
Poland
State/province [77] 0 0
Zachodniopomorskie
Country [78] 0 0
Portugal
State/province [78] 0 0
Lisboa
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Puerto Rico
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Hato Rey
Country [80] 0 0
Puerto Rico
State/province [80] 0 0
San Juan
Country [81] 0 0
Romania
State/province [81] 0 0
Bucuresti
Country [82] 0 0
Romania
State/province [82] 0 0
Cluj
Country [83] 0 0
Singapore
State/province [83] 0 0
Central Singapore
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Valenciana, Comunitat
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Cordoba
Country [88] 0 0
Spain
State/province [88] 0 0
Sevilla
Country [89] 0 0
Switzerland
State/province [89] 0 0
Basel-Stadt
Country [90] 0 0
Switzerland
State/province [90] 0 0
Berne
Country [91] 0 0
Switzerland
State/province [91] 0 0
Zurich
Country [92] 0 0
Taiwan
State/province [92] 0 0
Changhua
Country [93] 0 0
Taiwan
State/province [93] 0 0
Kaohsiung
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Taiwan
State/province [94] 0 0
Tainan
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
England
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London, City Of
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Blackpool
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.

The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Trial website
https://clinicaltrials.gov/study/NCT06312176
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/NCT06312176