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Could an mRNA vaccine stop kidney cancer from returning?

NCT ID NCT06307431

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether adding an experimental mRNA vaccine (V940) to standard immunotherapy (pembrolizumab) can prevent kidney cancer from coming back after surgery. About 272 people with high-risk kidney cancer will receive either the vaccine plus immunotherapy or a placebo plus immunotherapy. The main goal is to see if the combination improves how long patients stay cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA vaccine (V940) plus immunotherapy (pembrolizumab)
What this could lead to
If it works, this combination could help prevent kidney cancer from coming back after surgery, offering a new option for high-risk patients.
What could go wrong
This is an early phase 2 trial with only 272 participants, so results may not apply to everyone. The mRNA vaccine is experimental, and side effects from the immunotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • Abramson Cancer Center ( Site 0107)

    Philadelphia, Pennsylvania, 19104, United States

  • Addenbrooke's Hospital ( Site 1004)

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

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

    Ankara, Turkey (Türkiye)

  • Asan Medical Center ( Site 1602)

    Seoul, 05505, South Korea

  • Asklepios Altona-Department of Urology ( Site 0410)

    Hamburg, 22763, Germany

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)

    Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

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

    Florence, Tuscany, 50134, Italy

  • Azienda Ospedaliero Universitaria di Parma ( Site 0503)

    Parma, 43126, Italy

  • BC Cancer Vancouver ( Site 0005)

    Vancouver, British Columbia, V5Z 4E6, Canada

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

    Boston, Massachusetts, 02215, United States

  • Bradfordhill-Clinical Area ( Site 1201)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CENTRE LEON BERARD ( Site 0305)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

  • CHU Besançon ( Site 0302)

    Besançon, Doubs, 25030, France

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

    Québec, Quebec, G1R 2J6, Canada

  • Centro Privado de RMI Rio Cuarto ( Site 1104)

    Río Cuarto, Córdoba Province, X5800ALB, Argentina

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

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

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)

    Berlin, 10117, Germany

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

    Taichung, 40447, Taiwan

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

    Duarte, California, 91010, United States

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

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute ( Site 0106)

    Durham, North Carolina, 27710, United States

  • Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)

    Izmir, 35100, Turkey (Türkiye)

  • FALP-UIDO ( Site 1202)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fiona Stanley Hospital-Medical Oncology ( Site 1503)

    Murdoch, Western Australia, 6150, Australia

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

    Milan, Lombardy, 20133, Italy

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

    Rome, Lazio, 00168, Italy

  • Fox Chase Cancer Center ( Site 0111)

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacion Estudios Clinicos ( Site 1111)

    Rosario, Santa Fe Province, S2000CEJ, Argentina

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

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • Gustave Roussy ( Site 0304)

    Villejuif, Île-de-France Region, 94805, France

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

    Seville, 41013, Spain

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)

    Ankara, 06230, Turkey (Türkiye)

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

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

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

    Barcelona, 08035, Spain

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

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hôpital Européen Georges Pompidou ( Site 0300)

    Paris, 75015, France

  • Institut Claudius Regaud ( Site 0303)

    Toulouse, Haute-Garonne, 31059, France

  • Instituto Alexander Fleming-Alexander Fleming ( Site 1101)

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

  • Klinikum Stuttgart - Katharinenhospital ( Site 0400)

    Stuttgart, Baden-Wurttemberg, 70174, Germany

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

    Macquarie University, New South Wales, 2109, Australia

  • Memorial Sloan Kettering Cancer Center ( Site 0100)

    New York, New York, 10065, United States

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • ONCOCENTRO APYS-ACEREY ( Site 1200)

    Viña del Mar, Valparaiso, 2520598, Chile

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

    Santiago, Region M. de Santiago, 8330073, Chile

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

    Brisbane, Queensland, 4029, Australia

  • Samsung Medical Center ( Site 1601)

    Seoul, 06351, South Korea

  • Seoul National University Hospital ( Site 1600)

    Seoul, 03080, South Korea

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

    Seoul, 03722, South Korea

  • St Bartholomew's Hospital ( Site 1000)

    London, London, City of, EC1A 7BE, United Kingdom

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

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Taichung Veterans General Hospital ( Site 1704)

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital ( Site 1703)

    Taipei, 112, Taiwan

  • The Christie NHS Foundation Trust ( Site 1001)

    Manchester, m20 4bx, United Kingdom

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

    Los Angeles, California, 90095, United States

  • UCSF Medical Center at Mission Bay ( Site 0108)

    San Francisco, California, 94158, United States

  • UT Southwestern Medical Center ( Site 0110)

    Dallas, Texas, 75390, United States

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

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Jena ( Site 0402)

    Jena, Thuringia, 07747, Germany

  • Western General Hospital ( Site 1003)

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Westmead Hospital ( Site 1501)

    Westmead, New South Wales, 2145, Australia

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

    New Haven, Connecticut, 06510, United States

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

    Munich, Bavaria, 81675, Germany

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