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A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06307431
Recruitment Status : Recruiting
First Posted : March 12, 2024
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
ModernaTX, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: V940 Biological: Pembrolizumab Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 10, 2024
Estimated Primary Completion Date : January 8, 2028
Estimated Study Completion Date : June 8, 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: V940
IM injection
Other Name: mRNA-4157

Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
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.
 Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Biological: Placebo
IM injection


Outcome Measures
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Primary Outcome Measures :
  1. Disease-Free Survival (DFS) [ Time Frame: up to ~43 months ]
    DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to ~96 months ]
    OS is defined as the time from randomization to death due to any cause.

  2. Distant Metastasis-free survival (DMFS) [ Time Frame: up to ~ 43 months ]
    DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

  3. Percentage of Participants Who Experience an Adverse Event (AE) [ Time Frame: up to ~15 months ]
    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants that experience at least one AE will be reported.

  4. Percentage of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: up to ~12 months ]
    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06307431


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Connecticut
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102) Recruiting
New Haven, Connecticut, United States, 06510
Contact: Study Coordinator    203-785-5720      
Australia, New South Wales
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) Recruiting
Macquarie University, New South Wales, Australia, 2109
Contact: Study Coordinator    +61 2 9812 3526      
Canada, Quebec
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008) Recruiting
Québec, Quebec, Canada, G1R 2J6
Contact: Study Coordinator    4185254444      
Chile
FALP-UIDO ( Site 1202) Recruiting
Santiago, Region M. De Santiago, Chile, 7500921
Contact: Study Coordinator    56224457254      
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205) Recruiting
Santiago, Region M. De Santiago, Chile, 8330032
Contact: Study Coordinator    56223547919      
Bradfordhill-Clinical Area ( Site 1201) Recruiting
Santiago, Region M. De Santiago, Chile, 8420383
Contact: Study Coordinator    +56954240753      
ONCOCENTRO APYS-ACEREY ( Site 1200) Recruiting
Viña del Mar, Valparaiso, Chile, 2520598
Contact: Study Coordinator    +56992369820      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
ModernaTX, Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06307431    
Other Study ID Numbers: V940-004
2023-505177-32 ( Other Identifier: EU CT )
First Posted: March 12, 2024    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action