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Renal Cell CarcinomaPhase 2INTerpath-004NCT06307431

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

A Phase 2 study testing Intismeran autogene and Pembrolizumab in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 63 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Intismeran autogene and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
63 sitesin 14 countries
Study dates
10 Apr 2024to 8 Jun 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

63 sites in 14 countries.

63 sites in 14 countries

United States11 sites

  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute-GU ( Site 0101)

    Boston, Massachusetts, 02215

  • UT Southwestern Medical Center ( Site 0110)

    Dallas, Texas, 75390

  • City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)

    Duarte, California, 91010

  • Duke Cancer Institute ( Site 0106)

    Durham, North Carolina, 27710

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

    Los Angeles, California, 90095

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center ( Site 0100)

    New York, New York, 10065

  • Abramson Cancer Center ( Site 0107)

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center ( Site 0111)

    Philadelphia, Pennsylvania, 19111

  • UCSF Medical Center at Mission Bay ( Site 0108)

    San Francisco, California, 94158

Other trials in United States

Germany6 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)

    Dresden, Saxony, 01307

  • Asklepios Altona-Department of Urology ( Site 0410)

    Hamburg, 22763

  • Universitätsklinikum Jena ( Site 0402)

    Jena, Thuringia, 07747

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit

    Munich, Bavaria, 81675

  • Klinikum Stuttgart - Katharinenhospital ( Site 0400)

    Stuttgart, Baden-Wurttemberg, 70174

Other trials in Germany

Argentina5 sites

  • Instituto Alexander Fleming-Alexander Fleming ( Site 1101)

    Buenos Aires, Buenos Aires F.D., 1426ANZ

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)

    Buenos Aires, Buenos Aires F.D., C1419AHN

  • Hospital Británico de Buenos Aires-Oncology ( Site 1106)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Centro Privado de RMI Rio Cuarto ( Site 1104)

    Río Cuarto, Córdoba Province, X5800ALB

  • Fundacion Estudios Clinicos ( Site 1111)

    Rosario, Santa Fe Province, S2000CEJ

Other trials in Argentina

France5 sites

  • CHU Besançon ( Site 0302)

    Besançon, Doubs, 25030

  • CENTRE LEON BERARD ( Site 0305)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

  • Hôpital Européen Georges Pompidou ( Site 0300)

    Paris, 75015

  • Institut Claudius Regaud ( Site 0303)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 0304)

    Villejuif, Île-de-France Region, 94805

Other trials in France

United Kingdom5 sites

  • Addenbrooke's Hospital ( Site 1004)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Western General Hospital ( Site 1003)

    Edinburgh, Midlothian, EH4 2XU

  • Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)

    Glasgow, Glasgow City, G12 0YN

  • St Bartholomew's Hospital ( Site 1000)

    London, London, City of, EC1A 7BE

  • The Christie NHS Foundation Trust ( Site 1001)

    Manchester, m20 4bx

Other trials in United Kingdom

Australia4 sites

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

    Brisbane, Queensland, 4029

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)

    Macquarie University, New South Wales, 2109

  • Fiona Stanley Hospital-Medical Oncology ( Site 1503)

    Murdoch, Western Australia, 6150

  • Westmead Hospital ( Site 1501)

    Westmead, New South Wales, 2145

Other trials in Australia

Chile4 sites

  • FALP-UIDO ( Site 1202)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)

    Santiago, Region M. de Santiago, 8330073

  • Bradfordhill-Clinical Area ( Site 1201)

    Santiago, Region M. de Santiago, 8420383

  • ONCOCENTRO APYS-ACEREY ( Site 1200)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Italy4 sites

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)

    Florence, Tuscany, 50134

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)

    Milan, Lombardy, 20133

  • Azienda Ospedaliero Universitaria di Parma ( Site 0503)

    Parma, 43126

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)

    Rome, Lazio, 00168

Other trials in Italy

South Korea4 sites

  • Seoul National University Hospital ( Site 1600)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System ( Site 1603)

    Seoul, 03722

  • Asan Medical Center ( Site 1602)

    Seoul, 05505

  • Samsung Medical Center ( Site 1601)

    Seoul, 06351

Other trials in South Korea

Taiwan4 sites

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • China Medical University Hospital-Department of Urology ( Site 1702)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 1704)

    Taichung, 40705

  • Taipei Veterans General Hospital ( Site 1703)

    Taipei, 112

Other trials in Taiwan

Poland3 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain3 sites

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)

    Madrid, Madrid, Comunidad de, 28034

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)

    Seville, 41013

Other trials in Spain

Turkey (Türkiye)3 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)

    Ankara, 06230

  • Ankara Universitesi Tip Fakultesi Hastanesi-Oncology ( Site 0902)

    Ankara

  • Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Canada2 sites

  • CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)

    Québec, Quebec, G1R 2J6

  • BC Cancer Vancouver ( Site 0005)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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 (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.

Being tested
Intismeran autogene, Pembrolizumab, Placebo
Keywords
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)
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • PlaceboBiological

    IM injection

Study groups in NCT06307431
Study groupRoleWhat they receive
Intismeran autogene + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Intismeran autogene; Biological: Pembrolizumab
Placebo + PembrolizumabActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    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.

    Measured: up to ~43 months

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: up to ~96 months

  2. Distant Metastasis-free survival (DMFS)

    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.

    Measured: up to ~ 43 months

  3. Percentage of Participants Who Experience an Adverse Event (AE)

    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.

    Measured: up to ~15 months

  4. Percentage of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Measured: up to ~12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start10 Apr 2024
  3. Primary completion8 Jan 2028 (estimated)
  4. Study completion8 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307431
Sponsor's protocol ID
V940-004
Other IDs
2023-505177-32-00, U1111-1291-1851, V940-004, 2023
Acronym
INTerpath-004
Status last verified
Jun 2026
First submitted
6 Mar 2024
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intismeran autogene and Pembrolizumab in people with Renal Cell Carcinoma, run by Merck Sharp & Dohme LLC at 63 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Germany, Argentina, France, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: up to ~43 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06307431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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