Clinical trial • Phase II • Oncology

MRNA-4157 for Renal cell carcinoma

Phase II trial of MRNA-4157 for Renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Renal cell carcinoma
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|mRNA

Key dates

Initial CTIS Submission Date
13-11-2023
First CTIS Authorization Date
19-03-2024

Trial design

Randomised, v940 (mrna-4157) plus pembrolizumab versus placebo plus pembrolizumab; placebo is saline solution nacl 0.9%. doses and schedules are not specified in the provided record.-controlled Phase II trial across 19 sites in Poland, France, Spain and others.

Randomised
Yes
Comparator
V940 (mRNA-4157) plus pembrolizumab versus placebo plus pembrolizumab; placebo is Saline solution NACl 0.9%. Doses and schedules are not specified in the provided record.
Target Sample Size
195

Eligibility

Recruits 195 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent/assent handling for vulnerable participants are provided in the record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent/assent handling for vulnerable participants are provided in the record.

Inclusion criteria

  • {"criterion_text":"- Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.\n- 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: a.\tIntermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0 b.\tHigh-risk RCC: pT4, N0, M0; pT any stage, N1, M0 c.\tM1 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)\n- 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.\n- Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization."}

Exclusion criteria

  • {"criterion_text":"- Has had a major surgery within 4 weeks prior to randomization.\n- Has residual thrombus post nephrectomy in the vena renalis or vena cava.\n- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n- Received prior treatment with a cancer vaccine.\n- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n- Has a history of brain or bone metastatic lesions.\n- Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.\n- Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- Has an active infection requiring systemic therapy.\n- History of allogeneic tissue/solid organ transplant.\n- Has not adequately recovered from major surgery or has ongoing surgical complications."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease-Free Survival (DFS)","definition_or_measurement_approach":"To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS as assessed by investigator"}

Secondary endpoints

  • {"endpoint_text":"- Distant Metastasis-free Survival (DMFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}

Other endpoints

  • {"endpoint_text":"- Quality of life questionnaires\n- Exploratory biomarkers","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
195
Recruitment Window Months
41
Consent Approach
Informed consent obtained from participants. Country-specific main ICFs and optional consent documents are available (document titles indicate Polish, French, Spanish, German, Italian and English language versions are provided). No specific details on assent or parental consent for vulnerable participants are provided in the available record.

Geography

Total Number Of Sites
19
Total Number Of Participants
101

Poland

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
808
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii I
Contact Person Name
Bogdan Żurawski
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Moczowego
Contact Person Name
Paweł Wiechno
Contact Person Email
badaniakliniczne@nio.gov.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl

France

Earliest CTIS Part Ii Submission Date
29-12-2023
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
857
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Institut Gustave Roussy
Department Name
Médecine Oncologique -Cancer du Rein
Contact Person Name
Laurence ALBIGES
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Oncologie médicale
Contact Person Name
Damien POUESSEL
Site Name
Besancon University Hospital Center
Department Name
Oncologie médicale
Contact Person Name
Hamadi ALMOTLAK
Contact Person Email
halmotlak@chu-besancon.fr
Site Name
Centre Leon Berard
Department Name
Cancérologie Médicale - Oncologie Urologique
Contact Person Name
Armelle VINCENEUX
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cancérologie Médicale
Contact Person Name
Stéphane OUDARD
Contact Person Email
stephane.oudard@aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
29-12-2023
Latest Decision Or Authorization Date
10-05-2026
Processing Time Days
863
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Javier Molina Cerrilllo
Contact Person Email
javier.molinace@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Cristina Suárez Rodríguez
Contact Person Email
csuarez@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Begoña Pérez Valderrama
Contact Person Email
bpvalderrama@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
14-02-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
813
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Urologie
Contact Person Name
Maria De Santis
Contact Person Email
maria.de-santis@charite.de
Site Name
University Hospital Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Marc-Oliver Grimm
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Stuttgart Cancer Center Standort Mitte (Katharinenhospital)
Contact Person Name
Jens Bedke
Contact Person Email
j.bedke@klinikum-stuttgart.de

Italy

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
833
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Giuseppe Procopio
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UOC Oncologia Medica
Contact Person Name
Sebastiano Buti
Contact Person Email
sbuti@ao.pr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia medica
Contact Person Name
Roberto Iacovelli
Site Name
Careggi University Hospital
Department Name
SOD Oncologia Medica
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
central Clinical Imaging
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
PPD Development LP
Responsibilities
sponsorDuties code 4
Name
PPD Global Central Labs
Responsibilities
sponsorDuties code 4
Name
Charles River Laboratories International Inc.
Responsibilities
sponsorDuties code 4
Name
Fortrea Inc.
Responsibilities
sponsorDuties code 1

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"central Clinical Imaging (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories International Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting) (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
mRNA-4157
Active Substance
MRNA-4157
Modality
mRNA
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular injection
Authorisation Status
prodAuthStatus: 1 (no marketing authorisation indicated in record)
Maximum Dose
Max daily dose 1 mg; max total dose 9 mg (as stated in product record)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation EU/1/15/1024/002 (authorisationCountryCode: EU)
Maximum Dose
Max daily dose 400 mg; max total dose 3600 mg (as stated in product record)
Combination Treatment
Yes

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