A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
Condition(s) studied
Investigational drug(s) / intervention(s)
Intismeran autogene: IM injection
Pembrolizumab: IV infusion
Placebo: IM injection
Study 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. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
Eligibility
Primary outcome measure(s)
- Disease-Free Survival (DFS) — 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.
Trial sites (63)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104) | Duarte | California | |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro | Los Angeles | California | |
| UCSF Medical Center at Mission Bay ( Site 0108) | San Francisco | California | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0102) | New Haven | Connecticut | |
| Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109) | Boston | Massachusetts | |
| Dana-Farber Cancer Institute-GU ( Site 0101) | Boston | Massachusetts | |
| Memorial Sloan Kettering Cancer Center ( Site 0100) | New York | New York | |
| Duke Cancer Institute ( Site 0106) | Durham | North Carolina | |
| Abramson Cancer Center ( Site 0107) | Philadelphia | Pennsylvania | |
| Fox Chase Cancer Center ( Site 0111) | Philadelphia | Pennsylvania | |
| UT Southwestern Medical Center ( Site 0110) | Dallas | Texas | |
| Hospital Británico de Buenos Aires-Oncology ( Site 1106) | Ciudad Autónoma de Buenos Aires | Buenos Aires | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 1101) | Buenos Aires | Buenos Aires F.D. | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110) | Buenos Aires | Buenos Aires F.D. | |
| Centro Privado de RMI Rio Cuarto ( Site 1104) | Río Cuarto | Córdoba Province | |
| Fundacion Estudios Clinicos ( Site 1111) | Rosario | Santa Fe Province | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) | Macquarie University | New South Wales | |
| Westmead Hospital ( Site 1501) | Westmead | New South Wales | |
| Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si | Brisbane | Queensland | |
| Fiona Stanley Hospital-Medical Oncology ( Site 1503) | Murdoch | Western Australia | |
| BC Cancer Vancouver ( Site 0005) | Vancouver | British Columbia | |
| CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008) | Québec | Quebec | |
| FALP-UIDO ( Site 1202) | Santiago | Region M. de Santiago | |
| Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 1201) | Santiago | Region M. de Santiago | |
| ONCOCENTRO APYS-ACEREY ( Site 1200) | Viña del Mar | Valparaiso | |
| CENTRE LEON BERARD ( Site 0305) | Lyon Cedex08 | Auvergne-Rhône-Alpes | |
| CHU Besançon ( Site 0302) | Besançon | Doubs | |
| Institut Claudius Regaud ( Site 0303) | Toulouse | Haute-Garonne | |
| Hôpital Européen Georges Pompidou ( Site 0300) | Paris | France | |
| Gustave Roussy ( Site 0304) | Villejuif | Île-de-France Region | |
| Klinikum Stuttgart - Katharinenhospital ( Site 0400) | Stuttgart | Baden-Wurttemberg | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit | Munich | Bavaria | |
| Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405) | Dresden | Saxony | |
| Universitätsklinikum Jena ( Site 0402) | Jena | Thuringia | |
| 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 | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500) | Milan | Lombardy | |
| Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504) | Florence | Tuscany |
+ 23 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06307431 on ClinicalTrials.gov ↗ ← All trials in the UK