Clinical trial NCT06307431: A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
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).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Renal Cell Carcinoma
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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: ModernaTX, Inc.
First posted: 2024-03-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 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 outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: up to ~43 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to ~96 months
measure: Distant Metastasis-free survival (DMFS)
timeFrame: up to ~ 43 months
measure: Percentage of Participants Who Experience an Adverse Event (AE)
timeFrame: up to ~15 months
measure: Percentage of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: up to ~12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay ( Site 0108)
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute-GU ( Site 0101)
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0100)
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 0106)
state: North Carolina
city: Philadelphia
country: United States
facility: Abramson Cancer Center ( Site 0107)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0111)
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 0110)
state: Texas
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 1106)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)
state: Caba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
state: Caba
city: Río Cuarto
country: Argentina
facility: Centro Privado de RMI Rio Cuarto ( Site 1104)
state: Cordoba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 1111)
state: Santa Fe
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 1501)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
state: Queensland
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital-Medical Oncology ( Site 1503)
state: Western Australia
city: Vancouver
country: Canada
facility: BC Cancer Vancouver ( Site 0005)
state: British Columbia
city: Québec
country: Canada
facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
state: Quebec
city: Santiago.
country: Chile
facility: Bradfordhill-Clinical Area ( Site 1201)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 1202)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 1200)
state: Valparaiso
city: Besançon
country: France
facility: CHU Besançon ( Site 0302)
state: Doubs
city: Toulouse
country: France
facility: Institut Claudius Regaud ( Site 0303)
state: Haute-Garonne
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0304)
state: Ile-de-France
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 0305)
state: Rhone-Alpes
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou ( Site 0300)
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital ( Site 0400)
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
state: Bayern
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena ( Site 0402)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)
city: Hamburg
country: Germany
facility: Asklepios Altona-Department of Urology ( Site 0410)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)
state: Toscana
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma ( Site 0503)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1600)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 1603)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1602)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1601)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S
state: Mazowieckie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
state: Zachodniopomorskie
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Department of Urology ( Site 1702)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1704)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1703)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi-Oncology ( Site 0902)
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 1004)
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)
state: Glasgow City
city: London
country: United Kingdom
facility: St Bartholomew's Hospital ( Site 1000)
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1003)
state: Midlothian
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1001)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: