Trial Title:
A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
NCT ID:
NCT06307431
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Pembrolizumab
Conditions: 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)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
V940
Description:
IM injection
Arm group label:
V940 + Pembrolizumab
Other name:
mRNA-4157
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV infusion
Arm group label:
Placebo + Pembrolizumab
Arm group label:
V940 + Pembrolizumab
Other name:
MK-3475
Other name:
KEYTRUDA®
Intervention type:
Biological
Intervention name:
Placebo
Description:
IM injection
Arm group label:
Placebo + Pembrolizumab
Summary:
The primary objective of the study is to compare V940 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 V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to
DFS.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
626-375-6004
Facility:
Name:
UCSF Medical Center at Mission Bay ( Site 0108)
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
415-514-6380
Facility:
Name:
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
203-785-5720
Facility:
Name:
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
617-632-9250
Facility:
Name:
Dana-Farber Cancer Institute-GU ( Site 0101)
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
617-632-5456
Facility:
Name:
Memorial Sloan Kettering Cancer Center ( Site 0100)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
646-422-4312
Facility:
Name:
Duke Cancer Institute ( Site 0106)
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
919-668-8650
Facility:
Name:
Abramson Cancer Center ( Site 0107)
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
215-662-7046
Facility:
Name:
Fox Chase Cancer Center ( Site 0111)
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
215-728-3889
Facility:
Name:
UT Southwestern Medical Center ( Site 0110)
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
301-512-7242
Facility:
Name:
Hospital Británico de Buenos Aires-Oncology ( Site 1106)
Address:
City:
Ciudad autónoma de Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
54911563819972
Facility:
Name:
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)
Address:
City:
Buenos Aires
Zip:
C1419AHN
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+541145740870
Facility:
Name:
Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
1426
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5491149455892
Facility:
Name:
Centro Privado de RMI Rio Cuarto ( Site 1104)
Address:
City:
Río Cuarto
Zip:
X5800ALB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5493585628491
Facility:
Name:
Fundacion Estudios Clinicos ( Site 1111)
Address:
City:
Rosario
Zip:
S2000CEJ
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5493469699922
Facility:
Name:
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
Address:
City:
Macquarie University
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+61 2 9812 3526
Facility:
Name:
Westmead Hospital-Department of Medical Oncology ( Site 1501)
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61411462609
Facility:
Name:
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Address:
City:
Brisbane
Zip:
4029
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61402240196
Facility:
Name:
Fiona Stanley Hospital-Medical Oncology ( Site 1503)
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61861520954
Facility:
Name:
BC Cancer Vancouver ( Site 0005)
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6048776000
Facility:
Name:
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
Address:
City:
Québec
Zip:
G1R 2J6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4185254444
Facility:
Name:
FALP-UIDO ( Site 1202)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
Address:
City:
Santiago
Zip:
8330032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56223547919
Facility:
Name:
Bradfordhill-Clinical Area ( Site 1201)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56954240753
Facility:
Name:
ONCOCENTRO APYS-ACEREY ( Site 1200)
Address:
City:
Viña del Mar
Zip:
2520598
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56992369820
Facility:
Name:
CHU Besançon ( Site 0302)
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33370632213
Facility:
Name:
Institut Claudius Regaud ( Site 0303)
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33531155151
Facility:
Name:
Gustave Roussy ( Site 0304)
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33142114211
Facility:
Name:
Hôpital Européen Georges Pompidou ( Site 0300)
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33156093447
Facility:
Name:
Klinikum Stuttgart - Katharinenhospital ( Site 0400)
Address:
City:
Stuttgart
Zip:
70174
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
49711 278-33801
Facility:
Name:
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
Address:
City:
Munich
Zip:
81675
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
498941402522
Facility:
Name:
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4930450515288
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390630154953
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390223903818
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0039 0557947298
Facility:
Name:
Azienda Ospedaliero Universitaria di Parma ( Site 0503)
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390521702682
Facility:
Name:
Seoul National University Hospital ( Site 1600)
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
01097705707
Facility:
Name:
Severance Hospital, Yonsei University Health System ( Site 1603)
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82222288138
Facility:
Name:
Asan Medical Center ( Site 1602)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230105977
Facility:
Name:
Samsung Medical Center ( Site 1601)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82234101767
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48501446778
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48225462331
Facility:
Name:
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48502204953
Facility:
Name:
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34913368263
Facility:
Name:
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34932746000
Facility:
Name:
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34955013068
Facility:
Name:
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
Address:
City:
Kaohsiung Niao Sung Dist
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu-Li Su
Phone:
+886773171233267
Facility:
Name:
China Medical University Hospital-Department of Urology ( Site 1702)
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chi-Ping Huang
Phone:
886-975-681295
Facility:
Name:
Taichung Veterans General Hospital ( Site 1704)
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jian-Ri Li
Phone:
886423592525ext 5120
Facility:
Name:
Taipei Veterans General Hospital ( Site 1703)
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yi-Hsiu Huang
Phone:
886228757519
Facility:
Name:
Addenbrooke's Hospital ( Site 1004)
Address:
City:
Cambridge
Zip:
CB2 2QQ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
44 (0) 1223 274401
Facility:
Name:
Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+44 141 3017064
Facility:
Name:
St Bartholomew's Hospital ( Site 1000)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
020 7822 8498
Facility:
Name:
Western General Hospital ( Site 1003)
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0131537100 ext 31035
Facility:
Name:
The Christie NHS Foundation Trust ( Site 1001)
Address:
City:
Manchester
Zip:
m20 4bx
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
01619561038
Start date:
April 10, 2024
Completion date:
June 8, 2032
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
ModernaTX, Inc.
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307431
http://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=V940-004&&kw=V940-004
