Clinical trial • Phase II • Oncology
Pembrolizumab for Renal cell carcinoma|Metastatic renal cell carcinoma
Phase II trial of Pembrolizumab for Renal cell carcinoma|Metastatic renal cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Renal cell carcinoma|Metastatic renal cell carcinoma
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-03-2024
- First CTIS Authorization Date
- 11-04-2024
Trial design
Randomised, open-label, control arm: pembrolizumab + axitinib; arm a: tobemstomig + axitinib; arm b: tiragolumab + tobemstomig + axitinib (doses and schedules not specified in the available metadata) Phase II trial across 27 sites in Spain, Poland, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control Arm: pembrolizumab + axitinib; Arm A: tobemstomig + axitinib; Arm B: tiragolumab + tobemstomig + axitinib (doses and schedules not specified in the available metadata)
- Target Sample Size
- 104
Eligibility
Recruits 104 Vulnerable population selection is indicated in the record. Subject information and informed consent forms (multiple versions) are provided, including specific ICFs titled for pregnant partner and infant authorization. Details on assent or exact consent-by-age procedures and languages in each form are not specified in the available metadata..
- Vulnerable Population
- Vulnerable population selection is indicated in the record. Subject information and informed consent forms (multiple versions) are provided, including specific ICFs titled for pregnant partner and infant authorization. Details on assent or exact consent-by-age procedures and languages in each form are not specified in the available metadata.
Inclusion criteria
- {"criterion_text":"- International Metastatic Renal Cell Carcinoma Database Consortium IMDC risk intermediate (score of 1 or 2), or poor (score of 3 to 6)"}
- {"criterion_text":"- Measurable disease, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"}
- {"criterion_text":"- Adequate hematologic and end-organ function (within 14 days prior to study treatment)"}
- {"criterion_text":"- Histologically confirmed clear-cell renal cell carcinoma renal cell carcinoma (ccRCC) with or without sarcomatoid features; non-clear-cell renal cell carcinoma (nccRCC) subtypes (papillary, chromophobe, and unclassified) are not allowed."}
- {"criterion_text":"- Negative hepatitis B surface antigen (HBsAg) test and hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening"}
- {"criterion_text":"- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening"}
Exclusion criteria
- {"criterion_text":"- Prior treatment for localized and/or metastatic RCC with systemic RCC directed therapy"}
- {"criterion_text":"- Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer"}
- {"criterion_text":"- Symptomatic, untreated, or actively progressing CNS metastases"}
- {"criterion_text":"- History of leptomeningeal disease"}
- {"criterion_text":"- Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment."}
- {"criterion_text":"- Moderate to severe hepatic impairment (Child-Pugh B or C)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence and severity of adverse events, with severity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. with the exception of cytokine release syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale","definition_or_measurement_approach":"Severity graded by NCI CTCAE v5.0, except CRS severity graded per ASTCT CRS Consensus Grading scale"}
Recruitment
- Planned Sample Size
- 104
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent is obtained using Subject Information and Informed Consent Forms (multiple versions present). Specific ICFs exist for pregnant partner and infant authorization and optional biopsy. Languages for protocol synopses and documents include English, French, Spanish, Polish and German; precise age-specific consent/assent procedures are not provided in the metadata.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 113
Spain
- Latest Decision Or Authorization Date
- 08-05-2025
- Number Of Sites
- 8
- Number Of Participants
- 31
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncologia
- Principal Investigator Name
- Regina Girones
- Principal Investigator Email
- girones_reg@gva.es
- Contact Person Name
- Regina Girones
- Contact Person Email
- girones_reg@gva.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncologia
- Principal Investigator Name
- Javier Puente Vazquez
- Principal Investigator Email
- javierpuente.hcsc@gmail.com
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncologia
- Principal Investigator Name
- Begoña Perez Valderrama
- Principal Investigator Email
- bpvalderrama@gmail.com
- Contact Person Name
- Begoña Perez Valderrama
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Oncologia
- Principal Investigator Name
- Maria José Mendez Vidal
- Principal Investigator Email
- Mj.mendez.sspa@juntadeandalucia.es
- Contact Person Name
- Maria José Mendez Vidal
- Contact Person Email
- Mj.mendez.sspa@juntadeandalucia.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncologia
- Principal Investigator Name
- Jose pablo Maroto Rey
- Principal Investigator Email
- jmaroto@santpau.cat
- Contact Person Name
- Jose pablo Maroto Rey
- Contact Person Email
- jmaroto@santpau.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncologia
- Principal Investigator Name
- Javier Molina Cerrillo
- Principal Investigator Email
- javier.molinace@gmail.com
- Contact Person Name
- Javier Molina Cerrillo
- Contact Person Email
- javier.molinace@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia
- Principal Investigator Name
- Cristina Suarez Rodriguez
- Principal Investigator Email
- csuarez@vhio.net
- Contact Person Name
- Cristina Suarez Rodriguez
- Contact Person Email
- csuarez@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncologia
- Principal Investigator Name
- Daniel Castellano
- Principal Investigator Email
- cdanicas@hotmail.com
- Contact Person Name
- Daniel Castellano
- Contact Person Email
- cdanicas@hotmail.com
Poland
- Latest Decision Or Authorization Date
- 13-05-2025
- Number Of Sites
- 7
- Number Of Participants
- 40
Sites
- Site Name
- Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
- Department Name
- Oddział Chemioterapii
- Principal Investigator Name
- Krzysztof Piętak
- Principal Investigator Email
- kpietak@grochowski.waw.pl
- Contact Person Name
- Krzysztof Piętak
- Contact Person Email
- kpietak@grochowski.waw.pl
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Dzienny Chemioterapii i Hematologii Onkologicznej
- Principal Investigator Name
- Dariusz Sawka
- Principal Investigator Email
- badaniadsawka@szpital-brzozow.pl
- Contact Person Name
- Dariusz Sawka
- Contact Person Email
- badaniadsawka@szpital-brzozow.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambolutorium Chemioterapii
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- zurawskib@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Onkologii i Poradnia Onkologiczna
- Principal Investigator Name
- Piotr Wysocki
- Principal Investigator Email
- klinikaonkologii@su.krakow.pl
- Contact Person Name
- Piotr Wysocki
- Contact Person Email
- klinikaonkologii@su.krakow.pl
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oddział Onkologii Klinicznej
- Principal Investigator Name
- Agata Chrzanowska – Kapica
- Principal Investigator Email
- agatachrzanowska77@gmail.com
- Contact Person Name
- Agata Chrzanowska – Kapica
- Contact Person Email
- agatachrzanowska77@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Klinika Onkologii, Oddział Chemioterapii
- Principal Investigator Name
- Piotr Tomczak
- Principal Investigator Email
- md.piotr.tomczak@gmail.com
- Contact Person Name
- Piotr Tomczak
- Contact Person Email
- md.piotr.tomczak@gmail.com
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy (duplicate listing may exist in record)
- Department Name
- Ambolutorium Chemioterapii
Germany
- Latest Decision Or Authorization Date
- 09-05-2025
- Number Of Sites
- 6
- Number Of Participants
- 28
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Urologische Klinik und Poliklinik
- Principal Investigator Name
- Margitta Retz
- Principal Investigator Email
- margitta.retz@tum.de
- Contact Person Name
- Margitta Retz
- Contact Person Email
- margitta.retz@tum.de
- Site Name
- Universitätsklinikum Hamburg-Eppendorf
- Department Name
- Martini-Klinik im UKE
- Principal Investigator Name
- Gunhild von Amsberg
- Principal Investigator Email
- g.von-amsberg@uke.de
- Contact Person Name
- Gunhild von Amsberg
- Contact Person Email
- g.von-amsberg@uke.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Principal Investigator Name
- Philipp Ivanyi
- Principal Investigator Email
- ivanyi.philipp@mh-hannover.de
- Contact Person Name
- Philipp Ivanyi
- Contact Person Email
- ivanyi.philipp@mh-hannover.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Urologie
- Principal Investigator Name
- Friedemann Zengerling
- Principal Investigator Email
- friedemann.zengerling@uniklinik-ulm.de
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- friedemann.zengerling@uniklinik-ulm.de
- Site Name
- Studienpraxis Urologie
- Principal Investigator Name
- Tilman Tödenhöfer
- Principal Investigator Email
- praxis@studienurologie.de
- Contact Person Name
- Tilman Tödenhöfer
- Contact Person Email
- praxis@studienurologie.de
- Site Name
- Universitätsklinikum Carl Gustav Carus
- Department Name
- Klinik für Urologie
- Principal Investigator Name
- Elena Abbate
- Principal Investigator Email
- sandra.locke@uniklinikum-dresden.de
- Contact Person Name
- Elena Abbate
- Contact Person Email
- sandra.locke@uniklinikum-dresden.de
France
- Latest Decision Or Authorization Date
- 12-06-2025
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- oncologie
- Principal Investigator Name
- Laurence Albiges
- Principal Investigator Email
- Laurence.ALBIGES@gustaveroussy.fr
- Contact Person Name
- Laurence Albiges
- Contact Person Email
- Laurence.ALBIGES@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- oncologie
- Principal Investigator Name
- Armelle Vinceneux
- Principal Investigator Email
- Armelle.VINCENEUX@lyon.unicancer.fr
- Contact Person Name
- Armelle Vinceneux
- Contact Person Email
- Armelle.VINCENEUX@lyon.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- oncologie
- Principal Investigator Name
- Florence Joly
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence Joly
- Contact Person Email
- f.joly@baclesse.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- oncologie
- Principal Investigator Name
- Marine Gross-Goupil
- Principal Investigator Email
- marine.gross-goupil@chu-bordeaux.fr
- Contact Person Name
- Marine Gross-Goupil
- Contact Person Email
- marine.gross-goupil@chu-bordeaux.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- oncologie
- Principal Investigator Name
- Bertrand Billemont
- Principal Investigator Email
- b.billemont@isc84.org
- Contact Person Name
- Bertrand Billemont
- Contact Person Email
- b.billemont@isc84.org
- Site Name
- Besancon University Hospital Center
- Department Name
- oncologie
- Principal Investigator Name
- Hamadi Almotlak
- Principal Investigator Email
- halmotlak@chu-besancon.fr
- Contact Person Name
- Hamadi Almotlak
- Contact Person Email
- halmotlak@chu-besancon.fr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Global CRO
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Swm Partners Limited","duties_or_roles":"Meeting Organizer","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- TOBEMSTOMIG
- Modality
- Monoclonal antibody
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- AG-013,736
- Active Substance
- AG-013,736
- Modality
- Small molecule
- Investigational Product Name
- Unnamed protein product (product id 495100)
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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