Clinical trial • Phase II | Phase III • Oncology

CEMIPLIMAB, FIANLIMAB for Malignant melanoma

Phase II | Phase III trial of CEMIPLIMAB, FIANLIMAB for Malignant melanoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Malignant melanoma
Trial Stage
Phase II | Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
30-09-2024

Trial design

Randomised, cemiplimab (libtayo 350 mg concentrate for solution for infusion; iv infusion) compared with the combination of cemiplimab plus fianlimab (iv infusions). placebo for fianlimab (saline/dextrose formulation sourced locally) is used as matching placebo where applicable. specific doses/schedules beyond libtayo 350 mg (maxdailydoseamount = 350 mg reported) are not fully specified in the ctis json.-controlled Phase II | Phase III trial in Ireland, Greece, Poland and others.

Randomised
Yes
Comparator
Cemiplimab (LIBTAYO 350 mg concentrate for solution for infusion; IV infusion) compared with the combination of Cemiplimab plus Fianlimab (IV infusions). Placebo for Fianlimab (saline/dextrose formulation sourced locally) is used as matching placebo where applicable. Specific doses/schedules beyond LIBTAYO 350 mg (maxDailyDoseAmount = 350 mg reported) are not fully specified in the CTIS JSON.
Target Sample Size
266

Eligibility

Recruits 266 Vulnerable population selection flag is set in the CTIS record (isVulnerablePopulationSelected = true). The public CTIS data does not provide further details on the specific vulnerable groups, consent or assent handling procedures; no explicit consent/assent text is present in the available JSON..

Vulnerable Population
Vulnerable population selection flag is set in the CTIS record (isVulnerablePopulationSelected = true). The public CTIS data does not provide further details on the specific vulnerable groups, consent or assent handling procedures; no explicit consent/assent text is present in the available JSON.

Inclusion criteria

  • {"criterion_text":"- All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol."}
  • {"criterion_text":"- Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol."}
  • {"criterion_text":"- Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization."}
  • {"criterion_text":"- All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated)."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1"}
  • {"criterion_text":"- Note: Other protocol-defined inclusion criteria apply"}

Exclusion criteria

  • {"criterion_text":"- Primary uveal melanoma"}
  • {"criterion_text":"- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment."}
  • {"criterion_text":"- Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion."}
  • {"criterion_text":"- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol."}
  • {"criterion_text":"- Use of immunosuppressive doses of corticosteroids (≥10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol."}
  • {"criterion_text":"- Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol."}
  • {"criterion_text":"- Participants with a history of myocarditis."}
  • {"criterion_text":"- History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication."}
  • {"criterion_text":"- Note: Other protocol-defined exclusion criteria apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)","definition_or_measurement_approach":"Pathological complete response (pCR) rate assessed by Blinded Independent Pathological Review (BIPR)."}

Secondary endpoints

  • {"endpoint_text":"- pCR rate as assessed by local pathologic review","definition_or_measurement_approach":"Pathological complete response (pCR) assessed by local pathologic review."}
  • {"endpoint_text":"- Event-Free Survival (EFS)","definition_or_measurement_approach":"EFS (definition per protocol; no further measurement detail in CTIS JSON)."}
  • {"endpoint_text":"- Distant metastasis-free survival (DMFS)","definition_or_measurement_approach":"DMFS (no further measurement detail in CTIS JSON)."}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"OS (no further measurement detail in CTIS JSON)."}
  • {"endpoint_text":"- Major pathological response (MPR) as assessed by BIPR","definition_or_measurement_approach":"MPR assessed by Blinded Independent Pathological Review (BIPR)."}
  • {"endpoint_text":"- MPR rate as assessed by local pathologic review","definition_or_measurement_approach":"MPR rate assessed by local pathologic review."}
  • {"endpoint_text":"- Objective Response Rate (ORR) assessed by investigator per RECIST 1.1 criteria","definition_or_measurement_approach":"ORR assessed by investigator according to RECIST 1.1 criteria."}
  • {"endpoint_text":"- ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria","definition_or_measurement_approach":"ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria."}
  • {"endpoint_text":"- Relapse-free survival (RFS)","definition_or_measurement_approach":"RFS (no further measurement detail in CTIS JSON)."}
  • {"endpoint_text":"- Occurrence of treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Occurrence/incidence of TEAEs (standard safety reporting; no further detail in CTIS JSON)."}
  • {"endpoint_text":"- Occurrence of immune-mediated adverse events (imAEs)","definition_or_measurement_approach":"Occurrence/incidence of immune-mediated adverse events (imAEs)."}
  • {"endpoint_text":"- Occurrence of serious adverse events (SAEs)","definition_or_measurement_approach":"Occurrence/incidence of SAEs."}
  • {"endpoint_text":"- Occurrence of adverse events of special interest (AESIs)","definition_or_measurement_approach":"Occurrence/incidence of AESIs."}
  • {"endpoint_text":"- Occurrence of TEAEs resulting in death","definition_or_measurement_approach":"Occurrence/incidence of TEAEs resulting in death."}
  • {"endpoint_text":"- Occurrence of interruption or discontinuation of study drug(s) due to TEAE.","definition_or_measurement_approach":"Occurrence of temporary or permanent interruption/discontinuation of study drug(s) due to TEAEs."}
  • {"endpoint_text":"- Occurrence of cancellation of surgery due to TEAE or delay to surgery","definition_or_measurement_approach":"Occurrence of cancellation or delay of planned surgery due to TEAEs."}
  • {"endpoint_text":"- Occurrence of laboratory abnormalities","definition_or_measurement_approach":"Occurrence/incidence of laboratory abnormalities (no further detail in CTIS JSON)."}
  • {"endpoint_text":"- Concentrations of fianlimab in serum","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentrations of fianlimab."}
  • {"endpoint_text":"- Concentrations of cemiplimab in serum","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentrations of cemiplimab."}
  • {"endpoint_text":"- Anti-drug antibodies (ADA) in serum to fianlimab","definition_or_measurement_approach":"Immunogenicity: ADA in serum to fianlimab."}
  • {"endpoint_text":"- ADA in serum to cemiplimab","definition_or_measurement_approach":"Immunogenicity: ADA in serum to cemiplimab."}
  • {"endpoint_text":"- Change from baseline in disease-related symptoms per Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale","definition_or_measurement_approach":"Patient-reported outcome: change from baseline per FACT-M Melanoma subscale."}
  • {"endpoint_text":"- Change from baseline in functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QoL) C30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Patient-reported outcome: change from baseline per EORTC QLQ-C30."}
  • {"endpoint_text":"- Change from baseline in global health status/QoL per EORTC QLQ-C30","definition_or_measurement_approach":"Patient-reported outcome: change from baseline in global health status per EORTC QLQ-C30."}
  • {"endpoint_text":"- Change from baseline in overall health state per European Quality of Life Dimension 5 (EQ-5D-5L)","definition_or_measurement_approach":"Patient-reported outcome: change from baseline per EQ-5D-5L."}

Recruitment

Planned Sample Size
266
Recruitment Window Months
80
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent form documents (multiple country-specific versions) are listed in the CTIS documents, but the CTIS JSON does not provide the full consent text, age-specific assent procedures, or available languages.

Geography

Total Number Of Sites
79
Total Number Of Participants
254

Ireland

Earliest CTIS Part Ii Submission Date
17-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
17
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Tallaght University Hospital
Department Name
Oncology department
Principal Investigator Name
Fergal Kelleher
Principal Investigator Email
Fergal.kelleher@tuh.ie
Contact Person Name
Fergal Kelleher
Contact Person Email
Fergal.kelleher@tuh.ie
Site Name
University Hospital Waterford
Department Name
Oncology department
Principal Investigator Name
Paula Calvert
Principal Investigator Email
paulam.calvert@hse.ie
Contact Person Name
Paula Calvert
Contact Person Email
paulam.calvert@hse.ie
Site Name
St Vincent's University Hospital
Department Name
Medical oncology research department
Principal Investigator Name
John Crown
Principal Investigator Email
john.crown@ccrt.ie
Contact Person Name
John Crown
Contact Person Email
john.crown@ccrt.ie
Site Name
Beaumont Hospital
Department Name
Oncology department
Principal Investigator Name
Jarushka Naidoo
Principal Investigator Email
cctu@beaumont.ie
Contact Person Name
Jarushka Naidoo
Contact Person Email
cctu@beaumont.ie

Greece

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
1
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
General University Hospital Of Larissa
Department Name
Department of Medical Oncology
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Metropolitan Hospital
Department Name
A’ Oncology Clinic
Principal Investigator Name
Dimitrios Bafaloukos
Principal Investigator Email
dbafaloukos@metropolitan-hospital.gr
Contact Person Name
Dimitrios Bafaloukos
Site Name
Bioclinic S.A.
Department Name
Oncology Department
Principal Investigator Name
Ioannis Boukovinas
Principal Investigator Email
ibouk@otenet.gr
Contact Person Name
Ioannis Boukovinas
Contact Person Email
ibouk@otenet.gr
Site Name
Laiko General Hospital Of Athens
Department Name
A’ Internal Medicine Clinic
Principal Investigator Name
Helen Gogas
Principal Investigator Email
helgogas@gmail.com
Contact Person Name
Helen Gogas
Contact Person Email
helgogas@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
10-01-2025
Processing Time Days
112
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Tkanek Miękkich Kości i Czerniaków
Principal Investigator Name
Piotr Rutkowski
Principal Investigator Email
badaniakliniczne@nio.gov.pl
Contact Person Name
Piotr Rutkowski
Contact Person Email
badaniakliniczne@nio.gov.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej, Chemioterapii
Principal Investigator Name
Wojciech Rogowski
Principal Investigator Email
tymoteusz.czujko@gmail.com
Contact Person Name
Wojciech Rogowski
Contact Person Email
tymoteusz.czujko@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
Principal Investigator Name
Jacek Mackiewicz
Principal Investigator Email
badania.ucwbk@ump.edu.pl
Contact Person Name
Jacek Mackiewicz
Contact Person Email
badania.ucwbk@ump.edu.pl

Austria

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
10
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Dermatology
Principal Investigator Name
Christoph Hoeller
Principal Investigator Email
christoph.hoeller@meduniwien.ac.at
Contact Person Name
Christoph Hoeller
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
University Hospital St. Poelten, Clinical Department of Dermatology and Venereology
Principal Investigator Name
Christine Hafner
Principal Investigator Email
christine.hafner@edu.kl.ac.at
Contact Person Name
Christine Hafner
Contact Person Email
christine.hafner@edu.kl.ac.at
Site Name
Medical University Of Graz
Department Name
Dermatology and Venereology
Principal Investigator Name
Ingrid Wolf
Principal Investigator Email
ingrid.wolf@medunigraz.at
Contact Person Name
Ingrid Wolf
Contact Person Email
ingrid.wolf@medunigraz.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Dermatology, Venereology and Allergology
Principal Investigator Name
Van Anh Nguyen
Principal Investigator Email
van.nguyen@i-med.ac.at
Contact Person Name
Van Anh Nguyen
Contact Person Email
van.nguyen@i-med.ac.at

France

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
10
Number Of Sites
17
Number Of Participants
55

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Département de dermatologie
Principal Investigator Name
Caroline Gaudy
Principal Investigator Email
Caroline.gaudy@ap-hm.fr
Contact Person Name
Caroline Gaudy
Contact Person Email
Caroline.gaudy@ap-hm.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Département de dermatologie
Principal Investigator Name
Laurent Machet
Principal Investigator Email
machet@univ-tours.fr
Contact Person Name
Laurent Machet
Contact Person Email
machet@univ-tours.fr
Site Name
Hopital Ambroise Pare
Department Name
Département de dermatologie
Principal Investigator Name
Philippe Saiag
Principal Investigator Email
philippe.saiag@uvsq.fr
Contact Person Name
Philippe Saiag
Contact Person Email
philippe.saiag@uvsq.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Département de dermatologie
Principal Investigator Name
Alice Hervieu
Principal Investigator Email
ahervieu@cgfl.fr
Contact Person Name
Alice Hervieu
Contact Person Email
ahervieu@cgfl.fr
Site Name
Hospices Civils De Lyon
Department Name
Département de dermatologie
Principal Investigator Name
Stéphane Dalle
Principal Investigator Email
Stephane.dalle@chu-lyon.fr
Contact Person Name
Stéphane Dalle
Contact Person Email
Stephane.dalle@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Département de dermatologie
Principal Investigator Name
Géraldine Jeudy
Principal Investigator Email
geraldine.jeudy@chu-dijon.fr
Contact Person Name
Géraldine Jeudy
Contact Person Email
geraldine.jeudy@chu-dijon.fr
Site Name
Centre Francois Baclesse
Department Name
Département de dermatologie
Principal Investigator Name
Michel De Pontville
Principal Investigator Email
m.de-pontville@baclesse.unicancer.fr
Contact Person Name
Michel De Pontville
Site Name
Hopital Saint Louis
Department Name
Département de dermatologie
Principal Investigator Name
Céleste Lebbe
Principal Investigator Email
Celeste.lebbe@aphp.fr
Contact Person Name
Céleste Lebbe
Contact Person Email
Celeste.lebbe@aphp.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Département de dermatologie
Principal Investigator Name
Hervé Maillard
Principal Investigator Email
hmaillard@ch-lemans.fr
Contact Person Name
Hervé Maillard
Contact Person Email
hmaillard@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Département de dermatologie
Principal Investigator Name
Caroline Dutriaux
Principal Investigator Email
Caroline.dutriaux@chu-bordeaux.fr
Contact Person Name
Caroline Dutriaux
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Département de dermatologie
Principal Investigator Name
Henri Montaudie
Principal Investigator Email
montaudie.h@chu-nice.fr
Contact Person Name
Henri Montaudie
Contact Person Email
montaudie.h@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Département de dermatologie
Principal Investigator Name
Laurent Mortier
Principal Investigator Email
laurent.mortier@chru-lille.fr
Contact Person Name
Laurent Mortier
Contact Person Email
laurent.mortier@chru-lille.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Département de dermatologie
Principal Investigator Name
Sandrine Mansard
Principal Investigator Email
smansard@chu-clermontferrand.fr
Contact Person Name
Sandrine Mansard
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Département de dermatologie
Principal Investigator Name
Gaëlle Quereux
Principal Investigator Email
Gaelle.quereux@chu-nantes.fr
Contact Person Name
Gaëlle Quereux
Contact Person Email
Gaelle.quereux@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Département de dermatologie
Principal Investigator Name
Julie Charles
Principal Investigator Email
jcharles@chu-grenoble.fr
Contact Person Name
Julie Charles
Contact Person Email
jcharles@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Département de dermatologie
Principal Investigator Name
Ewa Hainaut - Wierzbicka
Principal Investigator Email
Ewa.hainaut@chu-poitiers.fr
Contact Person Name
Ewa Hainaut - Wierzbicka
Contact Person Email
Ewa.hainaut@chu-poitiers.fr
Site Name
Institut Gustave Roussy
Department Name
Département de dermatologie
Principal Investigator Name
Caroline Robert
Principal Investigator Email
Caroline.robert@gustaveroussy.fr
Contact Person Name
Caroline Robert

Spain

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
17
Number Of Sites
15
Number Of Participants
51

Sites

Site Name
University Hospital Son Espases
Department Name
Oncology
Principal Investigator Name
Pablo Luna Fra
Principal Investigator Email
Pablo.luna@ssib.es
Contact Person Name
Pablo Luna Fra
Contact Person Email
Pablo.luna@ssib.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
María González Cao
Principal Investigator Email
mgonzalezcao@oncorosell.com
Contact Person Name
María González Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Principal Investigator Name
Javier Valdivia Bautista
Principal Investigator Email
jvaldib@gmail.com
Contact Person Name
Javier Valdivia Bautista
Contact Person Email
jvaldib@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Jose Luis Manzano Mozo
Principal Investigator Email
jmanzano@iconcologia.net
Contact Person Name
Jose Luis Manzano Mozo
Contact Person Email
jmanzano@iconcologia.net
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Maria Isabel Palacio Vázquez
Principal Investigator Email
Isabel.palacio@sespa.es
Contact Person Name
Maria Isabel Palacio Vázquez
Contact Person Email
Isabel.palacio@sespa.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Jose Luis Manzano Mozo
Principal Investigator Email
jmanzano@iconcologia.net
Contact Person Name
Jose Luis Manzano Mozo
Contact Person Email
jmanzano@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Ivan Márquez Rodas
Principal Investigator Email
ivanpantic@hotmail.com
Contact Person Name
Ivan Márquez Rodas
Contact Person Email
ivanpantic@hotmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Inés Gonzalez Barrallo
Principal Investigator Email
igbarrallo@gmail.com
Contact Person Name
Inés Gonzalez Barrallo
Contact Person Email
igbarrallo@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Eva Muñoz Couselo
Principal Investigator Email
emunoz@vhio.net
Contact Person Name
Eva Muñoz Couselo
Contact Person Email
emunoz@vhio.net
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Principal Investigator Name
Pablo Cerezuela Fuentes
Principal Investigator Email
pcerezuelaf@seom.org
Contact Person Name
Pablo Cerezuela Fuentes
Contact Person Email
pcerezuelaf@seom.org
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Maria José Juan Fita
Principal Investigator Email
mjjuan@fivo.org
Contact Person Name
Maria José Juan Fita
Contact Person Email
mjjuan@fivo.org
Site Name
Hospital Universitario De Salamanca
Department Name
Dermatology
Principal Investigator Name
Javier Cañueto Alvarez
Principal Investigator Email
jcanueto@usal.es
Contact Person Name
Javier Cañueto Alvarez
Contact Person Email
jcanueto@usal.es
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Principal Investigator Name
Silvia Sequero Lopez
Principal Investigator Email
Silsq90@gmail.com
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
Silsq90@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Cristina Carrera Álvarez
Principal Investigator Email
ccarrera@clinic.cat
Contact Person Name
Cristina Carrera Álvarez
Contact Person Email
ccarrera@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
María Almudena García Castaño
Principal Investigator Email
algarcia@humv.es
Contact Person Name
María Almudena García Castaño
Contact Person Email
algarcia@humv.es

Italy

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
18
Number Of Sites
14
Number Of Participants
48

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department od Medical and Surgical Sciences
Principal Investigator Name
Ernesto Rossi
Principal Investigator Email
ernesto.rossi@policlinicogemelli.it
Contact Person Name
Ernesto Rossi
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Tumori Rari e Melanoma
Principal Investigator Name
Michele Guida
Principal Investigator Email
m.guida@oncologico.bari.it
Contact Person Name
Michele Guida
Contact Person Email
m.guida@oncologico.bari.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
SOC Oncologia, P.O. Santa Maria della Misericordia
Principal Investigator Name
Alessandro Marco Minisini
Principal Investigator Email
alessandro.minisini@asufc.sanita.fvg.it
Contact Person Name
Alessandro Marco Minisini
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2
Principal Investigator Name
Riccardo Marconcini
Principal Investigator Email
r.marconcini@ao-pisa.toscana.it
Contact Person Name
Riccardo Marconcini
Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology and Hematology
Principal Investigator Name
Maria Chiara Tronconi
Principal Investigator Email
maria_chiara.tronconi@humanitas.it
Contact Person Name
Maria Chiara Tronconi
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Medica del Melanoma e Sarcomi
Principal Investigator Name
Maristella Saponara
Principal Investigator Email
Maristella.saponara@ieo.it
Contact Person Name
Maristella Saponara
Contact Person Email
Maristella.saponara@ieo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Melanoma Cancer Immunotherapy and Development Therapeutics Unit
Principal Investigator Name
Paolo Antonio Ascierto
Principal Investigator Email
p.ascierto@istitutotumori.na.it
Contact Person Name
Paolo Antonio Ascierto
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOC Medical Oncology
Principal Investigator Name
Giuseppe Tonini
Principal Investigator Email
g.tonini@unicampus.it
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@unicampus.it
Site Name
University Hospital Of Ferrara
Department Name
UO Oncologia
Principal Investigator Name
Luana Calabrò
Principal Investigator Email
luana.calabro@unife.it
Contact Person Name
Luana Calabrò
Contact Person Email
luana.calabro@unife.it
Site Name
Ospedale San Vincenzo Taormina
Department Name
Divisione Oncologia Medica
Principal Investigator Name
Francesco Ferraù
Principal Investigator Email
ferrau@oncologiataormina.it
Contact Person Name
Francesco Ferraù
Contact Person Email
ferrau@oncologiataormina.it
Site Name
Istituto Nazionale Dei Tumori
Department Name
Medical Oncology and Hematology
Principal Investigator Name
Michele Del Vecchio
Principal Investigator Email
michele.delvecchio@istitutotumori.mi.it
Contact Person Name
Michele Del Vecchio
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncologia Medica ed Ematologia- Department of precision medicine
Principal Investigator Name
Teresa Troiani
Principal Investigator Email
Teresa.troiani@unicampania.it
Contact Person Name
Teresa Troiani
Contact Person Email
Teresa.troiani@unicampania.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Principal Investigator Name
Andrea Pietro Sponghini
Principal Investigator Email
andrea.sponghini@maggioreosp.novara.it
Contact Person Name
Andrea Pietro Sponghini
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
SC Oncologia
Principal Investigator Name
Marcella Occelli
Principal Investigator Email
Ocelli.m@ospedale.cuneo.it
Contact Person Name
Marcella Occelli
Contact Person Email
Ocelli.m@ospedale.cuneo.it

Germany

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
9
Number Of Sites
18
Number Of Participants
68

Sites

Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit (KFE)
Principal Investigator Name
Jan Christoph Simon
Principal Investigator Email
Jan-Christoph.Simon@medizin.uni-leipzig.de
Contact Person Name
Jan Christoph Simon
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Dermatologie und Allergologie, Hauttumorzentrum
Principal Investigator Name
Mihaela-Anca Sindrilaru
Principal Investigator Email
Mihaela-Anca.Sindrilaru@uniklinik-ulm.de
Contact Person Name
Mihaela-Anca Sindrilaru
Site Name
Medical Center - University Of Freiburg
Department Name
Zentrum Klinische Studien (ZKS) Klinik für Dermatologie und Venerologie
Principal Investigator Name
Frank Meiss
Principal Investigator Email
Frank.meiss@uniklinik-freiburg.de
Contact Person Name
Frank Meiss
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Friedegund Meier
Principal Investigator Email
friedegund.meier@uniklinikum-dresden.de
Contact Person Name
Friedegund Meier
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Thomas Eigentler
Principal Investigator Email
thomas.eigentler@charite.de
Contact Person Name
Thomas Eigentler
Contact Person Email
thomas.eigentler@charite.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Klinik für Dermatologie, Venerologie und Allergologie, Hautkrebszentrum Kiel
Principal Investigator Name
Katharina Kähler
Principal Investigator Email
Katharina.Kaehler@uksh.de
Contact Person Name
Katharina Kähler
Contact Person Email
Katharina.Kaehler@uksh.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Dirk Schadendorf
Principal Investigator Email
Dirk.Schadendorf@uk-essen.de
Contact Person Name
Dirk Schadendorf
Contact Person Email
Dirk.Schadendorf@uk-essen.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Sebatian Haferkamp
Principal Investigator Email
sebastian.haferkamp@ukr.de
Contact Person Name
Sebatian Haferkamp
Contact Person Email
sebastian.haferkamp@ukr.de
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Klinik für Hautkrankheiten und Allergologie
Principal Investigator Name
Sabine Sell
Principal Investigator Email
Sabine.Sell@srh.de
Contact Person Name
Sabine Sell
Contact Person Email
Sabine.Sell@srh.de
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Klinik für Hautkrankheiten und Allergologie
Principal Investigator Name
Rudolf A. Herbst
Principal Investigator Email
rudolf.herbst@helios-gesundheit.de
Contact Person Name
Rudolf A. Herbst
Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Hautklinik
Principal Investigator Name
Edgar Dippel
Principal Investigator Email
dippele@kliku.de
Contact Person Name
Edgar Dippel
Contact Person Email
dippele@kliku.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Hautklinik Klinik für Dermatologie, Allergologie und Venerologie
Principal Investigator Name
Evelyn Gaffal
Principal Investigator Email
Evelyn.gaffal@uksh.de
Contact Person Name
Evelyn Gaffal
Contact Person Email
Evelyn.gaffal@uksh.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Principal Investigator Name
Lucie Heinzerling
Principal Investigator Email
Lucie.heinzerling@med.uni-muenchen.de
Contact Person Name
Lucie Heinzerling
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Eggert Stockfleth
Principal Investigator Email
eggert.stockfleth@klinikum-bochum.de
Contact Person Name
Eggert Stockfleth
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Hautklinik Hautkrebszentrum der Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Anja Heike Gesierich
Principal Investigator Email
Gesierich_a@ukw.de
Contact Person Name
Anja Heike Gesierich
Contact Person Email
Gesierich_a@ukw.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Clinic for Pneumology and Respiratory medicine
Principal Investigator Name
Ulrich Ritter
Principal Investigator Email
ulrich.ritter@gesundheitnord.de
Contact Person Name
Ulrich Ritter
Site Name
University Hospital Giessen Universitätsklinikum Giessen und Marburg GmbH
Department Name
Dermatologie
Principal Investigator Name
Daniela Göppner
Principal Investigator Email
Daniela.goeppner@derma.med.uni-giessen.de
Contact Person Name
Daniela Göppner
Site Name
Elbe Kliniken Stade-Buxtehude gGmbH
Department Name
Klinik für Dermatologie Hautkrebszentrum Buxtehude Dermatologisches Zentrum
Principal Investigator Name
Peter Mohr
Principal Investigator Email
Peter.mohr@elbekliniken.de
Contact Person Name
Peter Mohr
Contact Person Email
Peter.mohr@elbekliniken.de

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO
Name
PRA Hellas CRO A.E.
Responsibilities
sponsorDuties codes: 1, 12, 2, 5

Third parties

  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Clinical Supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"Specialty Lab - ctDNA testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"IRT and eCOA","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Lab","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Rad Md LLC","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Cemiplimab and Fianlimab - 1
Active Substance
CEMIPLIMAB, FIANLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
Fianlimab
Active Substance
FIANLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
Placebo for Fianlimab
Modality
Other
Investigational Product Name
Cemiplimab & Fianlimab - 2
Active Substance
CEMIPLIMAB, FIANLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
LIBTAYO 350 mg concentrate for solution for infusion.
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketing authorisation EU/1/19/1376/001)
Maximum Dose
350 mg
Combination Treatment
Yes

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