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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06307431




Registration number
NCT06307431
Ethics application status
Date submitted
6/03/2024
Date registered
12/03/2024

Titles & IDs
Public title
A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
Scientific title
A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004)
Secondary ID [1] 0 0
2023-505177-32
Secondary ID [2] 0 0
V940-004
Universal Trial Number (UTN)
Trial acronym
INTerpath-004
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

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

Experimental: V940 + Pembrolizumab - Participants will receive V940 1 mg via intramuscular (IM) injection every 3 weeks (Q3W) for up to 9 doses plus Pembrolizumab 400 mg via an intravenous (IV) infusion every 6 weeks (Q6W) for 9 cycles (up to \~54 weeks). Each cycle is 6 weeks.

Active comparator: Placebo + Pembrolizumab - Participants will receive placebo as an IM injection Q3W for up to 9 doses plus Pembrolizumab 400 mg via an IV infusion Q6W for 9 cycles (up to \~54 weeks). Each cycle is 6 weeks.


Treatment: Other: V940
IM injection

Treatment: Other: Pembrolizumab
IV infusion

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

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS)
Timepoint [1] 0 0
up to ~43 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to ~96 months
Secondary outcome [2] 0 0
Distant Metastasis-free survival (DMFS)
Timepoint [2] 0 0
up to ~ 43 months
Secondary outcome [3] 0 0
Percentage of Participants Who Experience an Adverse Event (AE)
Timepoint [3] 0 0
up to ~15 months
Secondary outcome [4] 0 0
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [4] 0 0
up to ~12 months

Eligibility
Key inclusion criteria
* Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
* Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
* Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
* High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
* M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or =2 years from nephrectomy (metachronous)
* Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
* Must have undergone a nephrectomy and/or metastasectomy =12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
* Has residual thrombus post nephrectomy in the vena renalis or vena cava.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior radiotherapy within 2 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. Administration of killed vaccines is allowed.
* Received prior treatment with a cancer vaccine.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has a history of brain or bone metastatic lesions.
* Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* History of allogeneic tissue/solid organ transplant.
* Has not adequately recovered from major surgery or has 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
10/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/06/2032
Actual
Sample size
Target
272
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) - Macquarie University
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 1501) - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [4] 0 0
Fiona Stanley Hospital-Medical Oncology ( Site 1503) - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
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
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
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
Cordoba
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Chile
State/province [14] 0 0
Region M. De Santiago
Country [15] 0 0
Chile
State/province [15] 0 0
Valparaiso
Country [16] 0 0
France
State/province [16] 0 0
Doubs
Country [17] 0 0
France
State/province [17] 0 0
Haute-Garonne
Country [18] 0 0
France
State/province [18] 0 0
Ile-de-France
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Wurttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
Country [22] 0 0
Germany
State/province [22] 0 0
Thuringen
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Italy
State/province [24] 0 0
Lazio
Country [25] 0 0
Italy
State/province [25] 0 0
Lombardia
Country [26] 0 0
Italy
State/province [26] 0 0
Toscana
Country [27] 0 0
Italy
State/province [27] 0 0
Parma
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Poland
State/province [29] 0 0
Kujawsko-pomorskie
Country [30] 0 0
Poland
State/province [30] 0 0
Mazowieckie
Country [31] 0 0
Poland
State/province [31] 0 0
Zachodniopomorskie
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid, Comunidad De
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Taiwan
State/province [35] 0 0
Kaohsiung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Turkey
State/province [38] 0 0
Ankara
Country [39] 0 0
Turkey
State/province [39] 0 0
Izmir
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cambridgeshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Glasgow City
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London, City Of
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Midlothian
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Manchester

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
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/NCT06307431