A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
NCT ID: NCT06307431
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
272 participants
INTERVENTIONAL
2024-04-10
2032-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms
NCT06307093
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
NCT05438420
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
NCT05738694
PSMA Therapy and Immunotherapy in Kidney Cancer
NCT06361810
Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
NCT03564691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Intismeran autogene
IM injection
Pembrolizumab
IV infusion
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.
Pembrolizumab
IV infusion
Placebo
IM injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intismeran autogene
IM injection
Pembrolizumab
IV infusion
Placebo
IM injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ModernaTX, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
Duarte, California, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 0108)
San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute-GU ( Site 0101)
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center ( Site 0100)
New York, New York, United States
Duke Cancer Institute ( Site 0106)
Durham, North Carolina, United States
Abramson Cancer Center ( Site 0107)
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0111)
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center ( Site 0110)
Dallas, Texas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1106)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
Buenos Aires, Buenos Aires F.D., Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)
Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Rio Cuarto ( Site 1104)
Río Cuarto, Córdoba Province, Argentina
Fundacion Estudios Clinicos ( Site 1111)
Rosario, Santa Fe Province, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 1501)
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland, Australia
Fiona Stanley Hospital-Medical Oncology ( Site 1503)
Murdoch, Western Australia, Australia
BC Cancer Vancouver ( Site 0005)
Vancouver, British Columbia, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
Québec, Quebec, Canada
FALP-UIDO ( Site 1202)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 1201)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 1200)
Viña del Mar, Región de Valparaíso, Chile
CENTRE LEON BERARD ( Site 0305)
Lyon Cedex08, Auvergne-Rhône-Alpes, France
CHU Besançon ( Site 0302)
Besançon, Doubs, France
Institut Claudius Regaud ( Site 0303)
Toulouse, Haute-Garonne, France
Hôpital Européen Georges Pompidou ( Site 0300)
Paris, , France
Gustave Roussy ( Site 0304)
Villejuif, Île-de-France Region, France
Klinikum Stuttgart - Katharinenhospital ( Site 0400)
Stuttgart, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
Munich, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
Dresden, Saxony, Germany
Universitätsklinikum Jena ( Site 0402)
Jena, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)
Berlin, , Germany
Asklepios Altona-Department of Urology ( Site 0410)
Hamburg, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria di Parma ( Site 0503)
Parma, , Italy
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Hospital ( Site 1600)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System ( Site 1603)
Seoul, , South Korea
Asan Medical Center ( Site 1602)
Seoul, , South Korea
Samsung Medical Center ( Site 1601)
Seoul, , South Korea
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)
Barcelona, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)
Seville, , Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital-Department of Urology ( Site 1702)
Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1704)
Taichung, , Taiwan
Taipei Veterans General Hospital ( Site 1703)
Taipei, , Taiwan
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)
Ankara, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi-Oncology ( Site 0902)
Ankara, , Turkey (Türkiye)
Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)
Izmir, , Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1004)
Cambridge, Cambridgeshire, United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)
Glasgow, Glasgow City, United Kingdom
St Bartholomew's Hospital ( Site 1000)
London, London, City of, United Kingdom
Western General Hospital ( Site 1003)
Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation Trust ( Site 1001)
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505177-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-1851
Identifier Type: REGISTRY
Identifier Source: secondary_id
V940-004
Identifier Type: OTHER
Identifier Source: secondary_id
V940-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.