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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06393374




Registration number
NCT06393374
Ethics application status
Date submitted
26/04/2024
Date registered
1/05/2024

Titles & IDs
Public title
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Scientific title
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
Secondary ID [1] 0 0
2023-504962-52
Secondary ID [2] 0 0
2870-012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple-Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Other - sac-TMT
Treatment: Drugs - Capecitabine

Experimental: Pembrolizumab + sac-TMT - Participants receive pembrolizumab every 6 weeks (q6w) in combination with sac-TMT every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sac-TMT infusions.

Active comparator: Treatment of Physician's Choice - Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.


Treatment: Other: Pembrolizumab
Pembrolizumab 400 mg intravenous (IV) infusion q6w

Treatment: Other: sac-TMT
sac-TMT 4 mg/kg IV infusion q2w

Treatment: Drugs: Capecitabine
Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
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
Invasive Disease-Free Survival (iDFS)
Timepoint [1] 0 0
Up to ~77 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~101 months
Secondary outcome [2] 0 0
Distant recurrence-free survival (DRFS)
Timepoint [2] 0 0
Up to ~101 months
Secondary outcome [3] 0 0
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30) Global Health Status/Quality of Life (QoL) Scores
Timepoint [3] 0 0
Baseline and up to ~60 months
Secondary outcome [4] 0 0
Change from baseline in EORTC QLQC30 Physical Functioning Score
Timepoint [4] 0 0
Baseline and up to ~60 months
Secondary outcome [5] 0 0
Change from baseline in EORTC QLQC30 Role Functioning Score
Timepoint [5] 0 0
Baseline and up to ~60 months
Secondary outcome [6] 0 0
Change from baseline in EORTC QLQC30 Fatigue Score
Timepoint [6] 0 0
Baseline and up to ~60 months
Secondary outcome [7] 0 0
Number of participants with =1 adverse event (AE)
Timepoint [7] 0 0
Up to ~42 weeks
Secondary outcome [8] 0 0
Number of participants discontinuing from study therapy due to AE(s)
Timepoint [8] 0 0
Up to 24 weeks

Eligibility
Key inclusion criteria
* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Has no evidence of locoregional or distant relapse, as assessed by the treating physician
* Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
* Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
* Has non-pathologic complete response at surgery
* Is able to continue on adjuvant pembrolizumab
* Randomization must be conducted within 12 weeks from surgical resection
* Completed adjuvant radiation therapy (if indicated) and recovered before randomization
* For male participants, agrees to refrain from donating sperm and either abstains from penile-vaginal intercourse or uses approved contraception for 100 days after the last dose of sac-TMT and 95 days after the last dose of capecitabine
* For female participants, is not a participant of childbearing potential (POCBP) or is a POCBP and uses highly effective contraception; agrees not to donate eggs for up to 190 days after the last dose of sac-TMT, 120 days after the last dose of pembrolizumab, and 185 days after the last dose of capecitabine; has a negative highly sensitive pregnancy test before the first dose of study intervention; and agrees to abstain from breastfeeding for at least 120 days after last dose of study therapy
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
* 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 randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
* Has Grade >2 peripheral neuropathy
* 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
* Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, Poly (ADP ribose) Polymerase (PARP) inhibitors, Antibody Drug Conjugates (ADCs), and/or immunotherapy, with the exception of adjuvant radiation therapy
* Is currently receiving a strong and/or moderate inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study
* Received prior radiotherapy within 3 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

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
24/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/12/2037
Actual
Sample size
Target
1530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703) - Macquarie University
Recruitment hospital [2] 0 0
Frankston Hospital-Oncology and Haematology ( Site 2704) - Frankston
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
3199 - Frankston
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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
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
Czechia
State/province [8] 0 0
Praha 5
Country [9] 0 0
Germany
State/province [9] 0 0
Saarland
Country [10] 0 0
Greece
State/province [10] 0 0
Attiki
Country [11] 0 0
Greece
State/province [11] 0 0
Kentriki Makedonia
Country [12] 0 0
Greece
State/province [12] 0 0
Thessaloniki
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem
Country [14] 0 0
Israel
State/province [14] 0 0
Petah Tikva
Country [15] 0 0
Israel
State/province [15] 0 0
Ramat Gan
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur
Country [18] 0 0
Norway
State/province [18] 0 0
Buskerud
Country [19] 0 0
Norway
State/province [19] 0 0
Oslo
Country [20] 0 0
Spain
State/province [20] 0 0
La Coruna
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid, Comunidad De
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Switzerland
State/province [24] 0 0
Berne
Country [25] 0 0
Switzerland
State/province [25] 0 0
Grisons
Country [26] 0 0
Switzerland
State/province [26] 0 0
Zurich

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

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/NCT06393374