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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
Secondary ID [1] 0 0
2023-505177-32
Secondary ID [2] 0 0
V940-004
Universal Trial Number (UTN)
Trial acronym
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
Pennsylvania
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Caba
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Argentina
State/province [9] 0 0
Santa Fe
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Chile
State/province [12] 0 0
Region M. De Santiago
Country [13] 0 0
Chile
State/province [13] 0 0
Valparaiso
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Italy
State/province [15] 0 0
Lazio
Country [16] 0 0
Italy
State/province [16] 0 0
Lombardia
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Poland
State/province [18] 0 0
Kujawsko-pomorskie
Country [19] 0 0
Poland
State/province [19] 0 0
Zachodniopomorskie
Country [20] 0 0
Taiwan
State/province [20] 0 0
Kaohsiung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridgeshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London, City Of
Country [25] 0 0
United Kingdom
State/province [25] 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
[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/NCT06307431