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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06077760




Registration number
NCT06077760
Ethics application status
Date submitted
5/10/2023
Date registered
11/10/2023

Titles & IDs
Public title
A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Secondary ID [1] 0 0
2023-504923-20
Secondary ID [2] 0 0
V940-002
Universal Trial Number (UTN)
Trial acronym
INTerpath-002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - V940
Treatment: Other - Pembrolizumab
Other interventions - Placebo

Experimental: V940 + Pembrolizumab - Participants will receive 1 mg of V940 via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Active comparator: Placebo + Pembrolizumab - Participants will receive V940-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.


Treatment: Other: V940
IM injection

Treatment: Other: Pembrolizumab
IV infusion

Other interventions: Placebo
IM injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease- Free Survival (DFS)
Timepoint [1] 0 0
Up to ~78 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~12 years
Secondary outcome [2] 0 0
Distant Metastasis-Free Survival (DMFS)
Timepoint [2] 0 0
Up to ~12 years
Secondary outcome [3] 0 0
Lung Cancer Specific Survival (LCSS)
Timepoint [3] 0 0
Up to ~12 years
Secondary outcome [4] 0 0
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Timepoint [4] 0 0
Baseline and up to ~12 years
Secondary outcome [5] 0 0
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Timepoint [5] 0 0
Baseline and up to ~12 years
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Timepoint [6] 0 0
Baseline and up to ~12 years
Secondary outcome [7] 0 0
Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
Timepoint [7] 0 0
Baseline and up to ~12 years
Secondary outcome [8] 0 0
Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
Timepoint [8] 0 0
Baseline and up to ~12 years
Secondary outcome [9] 0 0
Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
Timepoint [9] 0 0
Baseline and up to ~12 years
Secondary outcome [10] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [10] 0 0
Up to ~15 months
Secondary outcome [11] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [11] 0 0
Up to ~12 months

Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:

* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
* Has no evidence of disease before randomization.
* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
* 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.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
21/12/2035
Actual
Sample size
Target
868
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203) - Melbourne
Recruitment hospital [2] 0 0
St Vincent's Hospital-Oncology Clinical Trials ( Site 0202) - Melbourne
Recruitment hospital [3] 0 0
One Clinical Research ( Site 0200) - Nedlands
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Santa Fe
Country [21] 0 0
Argentina
State/province [21] 0 0
Caba
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Norte
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio Grande Do Sul
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Chile
State/province [26] 0 0
Region M. De Santiago
Country [27] 0 0
Chile
State/province [27] 0 0
Valparaiso
Country [28] 0 0
Costa Rica
State/province [28] 0 0
San Jose
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno-mesto
Country [30] 0 0
Czechia
State/province [30] 0 0
Ostrava Mesto
Country [31] 0 0
Czechia
State/province [31] 0 0
Olomouc
Country [32] 0 0
Denmark
State/province [32] 0 0
Hovedstaden
Country [33] 0 0
Denmark
State/province [33] 0 0
Syddanmark
Country [34] 0 0
Estonia
State/province [34] 0 0
Harjumaa
Country [35] 0 0
Estonia
State/province [35] 0 0
Tartumaa
Country [36] 0 0
France
State/province [36] 0 0
Alsace
Country [37] 0 0
France
State/province [37] 0 0
Aquitaine
Country [38] 0 0
France
State/province [38] 0 0
Herault
Country [39] 0 0
France
State/province [39] 0 0
Maine-et-Loire
Country [40] 0 0
France
State/province [40] 0 0
Puy-de-Dome
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
Germany
State/province [42] 0 0
Thuringen
Country [43] 0 0
Greece
State/province [43] 0 0
Attiki
Country [44] 0 0
Greece
State/province [44] 0 0
Thessaloniki
Country [45] 0 0
Hungary
State/province [45] 0 0
Bacs-Kiskun
Country [46] 0 0
Hungary
State/province [46] 0 0
Baranya
Country [47] 0 0
Hungary
State/province [47] 0 0
Gyor-Moson-Sopron
Country [48] 0 0
Hungary
State/province [48] 0 0
Pest
Country [49] 0 0
Hungary
State/province [49] 0 0
Somogy
Country [50] 0 0
Ireland
State/province [50] 0 0
Dublin
Country [51] 0 0
Italy
State/province [51] 0 0
Friuli-Venezia Giulia
Country [52] 0 0
Italy
State/province [52] 0 0
Lombardia
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Puglia
Country [55] 0 0
Italy
State/province [55] 0 0
Sicilia
Country [56] 0 0
Italy
State/province [56] 0 0
Umbria
Country [57] 0 0
Italy
State/province [57] 0 0
Novara
Country [58] 0 0
Latvia
State/province [58] 0 0
Riga
Country [59] 0 0
Lithuania
State/province [59] 0 0
Kauno Apskritis
Country [60] 0 0
Lithuania
State/province [60] 0 0
Vilniaus Miestas
Country [61] 0 0
Malaysia
State/province [61] 0 0
Pahang
Country [62] 0 0
New Zealand
State/province [62] 0 0
Canterbury
Country [63] 0 0
New Zealand
State/province [63] 0 0
Auckland
Country [64] 0 0
Norway
State/province [64] 0 0
Akershus
Country [65] 0 0
Norway
State/province [65] 0 0
Buskerud
Country [66] 0 0
Norway
State/province [66] 0 0
Rogaland
Country [67] 0 0
Poland
State/province [67] 0 0
Kujawsko-pomorskie
Country [68] 0 0
Poland
State/province [68] 0 0
Mazowieckie
Country [69] 0 0
Poland
State/province [69] 0 0
Podkarpackie
Country [70] 0 0
Poland
State/province [70] 0 0
Podlaskie
Country [71] 0 0
Poland
State/province [71] 0 0
Wielkopolskie
Country [72] 0 0
Portugal
State/province [72] 0 0
Lisboa
Country [73] 0 0
Portugal
State/province [73] 0 0
Porto
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid, Comunidad De
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Malaga
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Taiwan
State/province [79] 0 0
Changhua
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taipei
Country [81] 0 0
Taiwan
State/province [81] 0 0
Hsinchu
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taichung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ModernaTX, Inc.
Address [1] 0 0
Country [1] 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
[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/NCT06077760