A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004). (INTerpath-004)

August 29, 2025 updated by: Merck Sharp & Dohme LLC

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).

The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Hospital Británico de Buenos Aires-Oncology ( Site 1106)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1426ANZ
        • Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
      • Buenos Aires, Buenos Aires F.D., Argentina, C1419AHN
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800ALB
        • Centro Privado de RMI Rio Cuarto ( Site 1104)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CEJ
        • Fundacion Estudios Clinicos ( Site 1111)
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital ( Site 1501)
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital-Medical Oncology ( Site 1503)
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver ( Site 0005)
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 1202)
      • Santiago, Region M. de Santiago, Chile, 8330073
        • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 1201)
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • ONCOCENTRO APYS-ACEREY ( Site 1200)
  • France
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou ( Site 0300)
    • Doubs
      • Besançon, Doubs, France, 25030
        • CHU Besançon ( Site 0302)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Institut Claudius Regaud ( Site 0303)
    • Rhone-Alpes
      • Lyon Cedex08, Rhone-Alpes, France, 69373
        • CENTRE LEON BERARD ( Site 0305)
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Gustave Roussy ( Site 0304)
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)
      • Hamburg, Germany, 22763
        • Asklepios Altona-Department of Urology ( Site 0410)
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70174
        • Klinikum Stuttgart - Katharinenhospital ( Site 0400)
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena ( Site 0402)
  • Italy
      • Parma, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma ( Site 0503)
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 1600)
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System ( Site 1603)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 1602)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 1601)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)
      • Seville, Spain, 41013
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital-Department of Urology ( Site 1702)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital ( Site 1704)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 1703)
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)
      • Ankara, Turkey (Türkiye)
        • Ankara Universitesi Tip Fakultesi Hastanesi-Oncology ( Site 0902)
      • Izmir, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • The Christie NHS Foundation Trust ( Site 1001)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital ( Site 1004)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital ( Site 1000)
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Western General Hospital ( Site 1003)
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay ( Site 0108)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute-GU ( Site 0101)
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 0100)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute ( Site 0106)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center ( Site 0107)
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center ( Site 0111)
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center ( Site 0110)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 has 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: Intismeran autogene + Pembrolizumab
Participants will receive intismeran autogene 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: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: Intismeran autogene
IM injection
Other Names:
  • mRNA-4157
  • V940

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to ~43 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: up to ~96 months
OS is defined as the time from randomization to death due to any cause.
up to ~96 months
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.
up to ~ 43 months
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.
up to ~15 months
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.
up to ~12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

January 8, 2028

Study Completion (Estimated)

June 8, 2032

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-004 (Other Identifier: MSD)
  • U1111-1291-1851 (Registry Identifier: UTN)
  • 2023-505177-32-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe