🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06307431
Active, not recruiting Phase 2

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

NCT06307431 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2024-04-10
Last updated
2026-07-13

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

Intismeran autogene →Pembrolizumab →Placebo

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
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 China

Other trials for the same condition

Official registry record

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 China