Clinical trial • Phase II/III • Oncology
PUMITAMIG for Colorectal cancer | Metastatic colorectal cancer
Phase II/III trial of PUMITAMIG for Colorectal cancer | Metastatic colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer | Metastatic colorectal cancer
- Trial Stage
- Phase II/III
- Drug Modality
- Peptide/protein/enzyme|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 31-10-2025
- First CTIS Authorization Date
- 10-03-2026
Trial design
Randomised, bevacizumab in combination with chemotherapy (standard of care); dose and schedule not specified. chemotherapy agents referenced in trial documents include oxaliplatin, fluorouracil, irinotecan, calcium folinate and capecitabine.-controlled, adaptive Phase II/III trial across 74 sites in Spain, Sweden, Netherlands and others.
- Randomised
- Yes
- Comparator
- Bevacizumab in combination with chemotherapy (standard of care); dose and schedule not specified. Chemotherapy agents referenced in trial documents include oxaliplatin, fluorouracil, irinotecan, calcium folinate and capecitabine.
- Adaptive
- True - Phase 2 includes dose-determination to select a dose for the Phase 3 part (dose-finding/possible dose escalation to inform Phase 3).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 644
Eligibility
Recruits 644 No vulnerable populations selected; participants must be at least 18 years and provide informed consent..
- Vulnerable Population
- No vulnerable populations selected; participants must be at least 18 years and provide informed consent.
Inclusion criteria
- {"criterion_text":"- Participants must be at least 18 years of age."}
- {"criterion_text":"- Have colorectal cancer that has come back or spread and cannot be cured with surgery."}
- {"criterion_text":"- Have not had cancer treatment before."}
- {"criterion_text":"- Do not have a type of colorectal cancer known as dMMR/MSI-H."}
- {"criterion_text":"- Do not have a BRAF V600E gene mutation."}
- {"criterion_text":"- Have cancer that can be measured on a scan."}
Exclusion criteria
- {"criterion_text":"- Have cancer that has spread to the brain, spinal cord, or surrounding areas and has not been treated."}
- {"criterion_text":"- Had other active cancer in the past 2 years (except low-risk cases that have been cured locally)."}
- {"criterion_text":"- Have serious heart problems, such as a recent heart attack, stroke, blocked arteries, uncontrolled high blood pressure, or certain genetic heart rhythm issues."}
- {"criterion_text":"- Have already had checkpoint inhibitors, CD137 agonists, or chemotherapy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).","definition_or_measurement_approach":"Compare the proportion of participants with objective response (OR) between study drug and standard of care arms."}
- {"endpoint_text":"- Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).","definition_or_measurement_approach":"Progression-free survival (PFS) defined as time from randomization to disease progression or death from any cause."}
Secondary endpoints
- {"endpoint_text":"- Phase 2: To assess all available data including how effective, safe and tolerable the study drug is to arrive at a dose.","definition_or_measurement_approach":"Assessment of efficacy, safety and tolerability data in Phase 2 to determine Phase 3 dose (dose-finding endpoints)."}
- {"endpoint_text":"- Phase 3: To evaluate how long patients live (OS) and how long the study drug effects on the tumor growth last after it is given (DOR).","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death; Duration of response (DOR) measured as duration tumor response lasts after treatment."}
Recruitment
- Planned Sample Size
- 644
- Recruitment Window Months
- 97
- Consent Approach
- Written informed consent is required from participants (adults ≥18 years). Subject information and informed consent form documents are provided in multiple country-specific versions and languages (examples in the dossier include English, Spanish, French, German, Dutch, Czech, Polish, Italian).
Geography
- Total Number Of Sites
- 74
- Total Number Of Participants
- 346
Spain
- Earliest CTIS Part Ii Submission Date
- 05-03-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 8
- Number Of Sites
- 8
- Number Of Participants
- 36
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Iosune Baraibar Argota
- Principal Investigator Email
- ibaraibar@vhio.net
- Contact Person Name
- Iosune Baraibar Argota
- Contact Person Email
- ibaraibar@vhio.net
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- Jose Manzano
- Principal Investigator Email
- jmanzano@iconcologia.net
- Contact Person Name
- Jose Manzano
- Contact Person Email
- jmanzano@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Pilar Garcia Alonso
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Pilar Garcia Alonso
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Maria Luisa Limon
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Maria Luisa Limon
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Maria Riesco
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Maria Riesco
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Ruth Vera
- Principal Investigator Email
- rveragar@cfnavarra.es
- Contact Person Name
- Ruth Vera
- Contact Person Email
- rveragar@cfnavarra.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Julia Alcaide
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Julia Alcaide
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario De Navarra (duplicate listing?)
- Department Name
- Oncology
- Principal Investigator Name
- Julia Alcaide
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Julia Alcaide
- Contact Person Email
- xxx.xxx@xxx.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Ongologiska kliniken
- Principal Investigator Name
- Leif Klint
- Principal Investigator Email
- leif.klint@vgregion.se
- Contact Person Name
- Leif Klint
- Contact Person Email
- leif.klint@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VO Hematologi, Onkologi och Strålningsfysik, Lasarettsgatan 23A, 221 85 Lund
- Principal Investigator Name
- Thorir Björgulfsson
- Principal Investigator Email
- thorir.marbjorgulfsson@skane.se
- Contact Person Name
- Thorir Björgulfsson
- Contact Person Email
- thorir.marbjorgulfsson@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Medicinsk enhet Övre Buk, GI onkologi
- Principal Investigator Name
- Mia Karlberg
- Principal Investigator Email
- mia.karlberg@regionstockholm.se
- Contact Person Name
- Mia Karlberg
- Contact Person Email
- mia.karlberg@regionstockholm.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-03-2026
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 24
Sites
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- Maartje Los
- Principal Investigator Email
- m.loss@antoniusziekenhuis.nl
- Contact Person Name
- Maartje Los
- Contact Person Email
- m.loss@antoniusziekenhuis.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Medical oncology
- Principal Investigator Name
- Tineke Buffart
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Tineke Buffart
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Stichting Elisabeth-TweeSteden Ziekenhuis
- Department Name
- Medical oncology
- Principal Investigator Name
- Robbert van Alphen
- Principal Investigator Email
- wetenschapsbureau@etz.nl
- Contact Person Name
- Robbert van Alphen
- Contact Person Email
- wetenschapsbureau@etz.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical oncology
- Principal Investigator Name
- Daan Knapen
- Principal Investigator Email
- medischeoncologiesecretariaat@onco.umcg.nl
- Contact Person Name
- Daan Knapen
- Contact Person Email
- medischeoncologiesecretariaat@onco.umcg.nl
Austria
- Earliest CTIS Part Ii Submission Date
- 03-03-2026
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- III Medical Departm. with Hematology, Medic. Oncology, Hemostaseology, Infect. Disease, Rheumatology
- Principal Investigator Name
- Lukas Weiss
- Principal Investigator Email
- lu.weiss@salk.at
- Contact Person Name
- Lukas Weiss
- Contact Person Email
- lu.weiss@salk.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Internal I, Medical Oncology and Hematology
- Principal Investigator Name
- Andreas Reichinger
- Principal Investigator Email
- andreas.reichinger@ordensklinikum.at
- Contact Person Name
- Andreas Reichinger
- Contact Person Email
- andreas.reichinger@ordensklinikum.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Medicine I, Division of Oncology
- Principal Investigator Name
- Gerald Prager
- Principal Investigator Email
- gerald.prager@meduniwien.ac.at
- Contact Person Name
- Gerald Prager
- Contact Person Email
- gerald.prager@meduniwien.ac.at
Germany
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 64
- Number Of Sites
- 11
- Number Of Participants
- 55
Sites
- Site Name
- Haematologisch Onkologische Praxis Eppendorf
- Department Name
- Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
- Principal Investigator Name
- Alexander Stein
- Principal Investigator Email
- stein@hope-hamburg.de
- Contact Person Name
- Alexander Stein
- Contact Person Email
- stein@hope-hamburg.de
- Site Name
- Marien Hospital Duesseldorf GmbH
- Department Name
- Klinik für Onkologie, Hämatologie und Palliativmedizin
- Principal Investigator Name
- Aristoteles Giagounidis
- Principal Investigator Email
- aristoteles.giagounidis@vkkd-kliniken.de
- Contact Person Name
- Aristoteles Giagounidis
- Contact Person Email
- aristoteles.giagounidis@vkkd-kliniken.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Med Klinik und Poliklinik I, Bereich Klinische Studien
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- gunnar.folprecht@uniklinikum-dresden.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- gunnar.folprecht@uniklinikum-dresden.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Markus Moehler
- Principal Investigator Email
- markus.moehler@unimedizin-mainz.de
- Contact Person Name
- Markus Moehler
- Contact Person Email
- markus.moehler@unimedizin-mainz.de
- Site Name
- Muenchen Klinik gGmbH
- Department Name
- Klinik für Onkologie und Hämatologie
- Principal Investigator Name
- Stefan Boeck
- Principal Investigator Email
- stefan.boeck@muenchen-klinik.de
- Contact Person Name
- Stefan Boeck
- Contact Person Email
- stefan.boeck@muenchen-klinik.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie, Onkologie und Krebs Immunologie (CCM)
- Principal Investigator Name
- Arndt Stahler
- Principal Investigator Email
- arndt.stahler@charite.de
- Contact Person Name
- Arndt Stahler
- Contact Person Email
- arndt.stahler@charite.de
- Site Name
- Heidelberg University
- Department Name
- Mannheim Cancer Center, Universität Heidelberg
- Principal Investigator Name
- Ralf-Dieter Hofheinz
- Principal Investigator Email
- ralf.hofheinz@umm.de
- Contact Person Name
- Ralf-Dieter Hofheinz
- Contact Person Email
- ralf.hofheinz@umm.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Thomas Seufferlein
- Principal Investigator Email
- thomas.seufferlein@uniklinik-ulm.de
- Contact Person Name
- Thomas Seufferlein
- Contact Person Email
- thomas.seufferlein@uniklinik-ulm.de
- Site Name
- Universitaet Leipzig
- Department Name
- Universitäres Krebszentrum Leipzig (UCCL)
- Principal Investigator Name
- Benjamin Kobitzsch
- Principal Investigator Email
- benjamin.kobitzsch@medizin.uni-leipzig.de
- Contact Person Name
- Benjamin Kobitzsch
- Contact Person Email
- benjamin.kobitzsch@medizin.uni-leipzig.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Hämatologie, Onkologie und Palliativmedizin
- Principal Investigator Name
- Anke Reinacher-Schick
- Principal Investigator Email
- anke.reinacher@rub.de
- Contact Person Name
- Anke Reinacher-Schick
- Contact Person Email
- anke.reinacher@rub.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Gastroenterologie und gastrointestinale Onkologie
- Principal Investigator Name
- Alexander König
- Principal Investigator Email
- alexander.koenig@med.uni-goettingen.de
- Contact Person Name
- Alexander König
- Contact Person Email
- alexander.koenig@med.uni-goettingen.de
Poland
- Earliest CTIS Part Ii Submission Date
- 10-02-2026
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 35
- Number Of Sites
- 8
- Number Of Participants
- 36
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Oddział Onkologii
- Principal Investigator Name
- Paweł Nurzyński
- Principal Investigator Email
- cwbk@pimmswia.gov.pl
- Contact Person Name
- Paweł Nurzyński
- Contact Person Email
- cwbk@pimmswia.gov.pl
- Site Name
- Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- Klinika Onkologii z Odcinkiem Dziennym
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- sekretariat@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- sekretariat@onkologia.opole.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Principal Investigator Name
- Wiesław Bal
- Principal Investigator Email
- cwbk@gliwice.nio.gov.pl
- Contact Person Name
- Wiesław Bal
- Contact Person Email
- cwbk@gliwice.nio.gov.pl
- Site Name
- Lux Med Onkologia Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej/Chemioterapii
- Principal Investigator Name
- Paweł Morawski
- Principal Investigator Email
- aos.rej.onkologia@luxmed.pl
- Contact Person Name
- Paweł Morawski
- Contact Person Email
- aos.rej.onkologia@luxmed.pl
- Site Name
- Mazowiecki Szpital Onkologiczny Sp. z o.o.
- Department Name
- Poradnia Onkologiczna
- Principal Investigator Name
- Joanna Omyla-Staszewska
- Principal Investigator Email
- a.jackowska@szpitalonkologiczny.pl
- Contact Person Name
- Joanna Omyla-Staszewska
- Contact Person Email
- a.jackowska@szpitalonkologiczny.pl
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej z Pododziałem Dziennym
- Principal Investigator Name
- Marek Jasiowka
- Principal Investigator Email
- badaniakliniczne@rydygierkrakow.pl
- Contact Person Name
- Marek Jasiowka
- Contact Person Email
- badaniakliniczne@rydygierkrakow.pl
- Site Name
- Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
- Department Name
- Oddział Onkologii Klinicznej i Chemioterapii
- Principal Investigator Name
- Katarzyna Woźniak
- Principal Investigator Email
- poczta@spzoz.jgora.pl
- Contact Person Name
- Katarzyna Woźniak
- Contact Person Email
- poczta@spzoz.jgora.pl
- Site Name
- Lux Med Onkologia (duplicate listing?)
- Department Name
- Oddział Onkologii Klinicznej/Chemioterapii
- Principal Investigator Name
- Paweł Morawski
- Principal Investigator Email
- aos.rej.onkologia@luxmed.pl
- Contact Person Name
- Paweł Morawski
- Contact Person Email
- aos.rej.onkologia@luxmed.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 17-11-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 119
- Number Of Sites
- 7
- Number Of Participants
- 34
Sites
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- office@centruldeoncologie.ro
- Contact Person Name
- Michael Schenker
- Contact Person Email
- office@centruldeoncologie.ro
- Site Name
- Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
- Department Name
- Oncology
- Principal Investigator Name
- Adrian Radu Vidra
- Principal Investigator Email
- abc@yahoo.com
- Contact Person Name
- Adrian Radu Vidra
- Contact Person Email
- abc@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Constantin Volovat
- Principal Investigator Email
- contact@victoriahospital.ro
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- contact@victoriahospital.ro
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Oncology
- Principal Investigator Name
- Bogdan Gafton
- Principal Investigator Email
- manager@iroiasi.ro
- Contact Person Name
- Bogdan Gafton
- Contact Person Email
- manager@iroiasi.ro
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Oncology
- Principal Investigator Name
- Adina Croitoru
- Principal Investigator Email
- secretariat@icfundeni.ro
- Contact Person Name
- Adina Croitoru
- Contact Person Email
- secretariat@icfundeni.ro
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca (duplicate listing?)
- Department Name
- Oncology
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 29
- Number Of Sites
- 4
- Number Of Participants
- 24
Sites
- Site Name
- University Of Antwerp
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Gastroenterology
- Principal Investigator Name
- Sofie De Meulder
- Principal Investigator Email
- sofie.demeulder@azdelta.be
- Contact Person Name
- Sofie De Meulder
- Contact Person Email
- sofie.demeulder@azdelta.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marc Van Den Eynde
- Principal Investigator Email
- marc.vandeneynde@uclouvain.be
- Contact Person Name
- Marc Van Den Eynde
- Contact Person Email
- marc.vandeneynde@uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology
- Principal Investigator Name
- Gertjan Rasschaert
- Principal Investigator Email
- gertjan.rasschaert@uzleuven.be
- Contact Person Name
- Gertjan Rasschaert
- Contact Person Email
- gertjan.rasschaert@uzleuven.be
Italy
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 60
- Number Of Sites
- 11
- Number Of Participants
- 44
Sites
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Onclologia Medica
- Principal Investigator Name
- Maria Banzi
- Principal Investigator Email
- maria.banzi@ausl.re.it
- Contact Person Name
- Maria Banzi
- Contact Person Email
- maria.banzi@ausl.re.it
- Site Name
- IRCCS - Ospedale San Raffaele
- Department Name
- Medical Oncology
- Principal Investigator Name
- Monica Ronzoni
- Principal Investigator Email
- ronzoni.monica@hsr.it
- Contact Person Name
- Monica Ronzoni
- Contact Person Email
- ronzoni.monica@hsr.it
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- U.O.C. di Oncologia
- Principal Investigator Name
- Tiziana Pia Latiano
- Principal Investigator Email
- t.latiano@operapadrepio.it
- Contact Person Name
- Tiziana Pia Latiano
- Contact Person Email
- t.latiano@operapadrepio.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Abdominal Oncology
- Principal Investigator Name
- Antonio Avallone
- Principal Investigator Email
- a.avallone@istitutotumori.na.it
- Contact Person Name
- Antonio Avallone
- Contact Person Email
- a.avallone@istitutotumori.na.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Oncologia Medica 2 Universitaria,
- Principal Investigator Name
- Gianluca Masi
- Principal Investigator Email
- gianluca.masi@unipi.it
- Contact Person Name
- Gianluca Masi
- Contact Person Email
- gianluca.masi@unipi.it
- Site Name
- Presidio Ospedaliero Garibaldi-Nesima
- Department Name
- U.O.C. Oncologia Medica
- Principal Investigator Name
- Roberto Bordonaro
- Principal Investigator Email
- oncoct@hotmail.com
- Contact Person Name
- Roberto Bordonaro
- Contact Person Email
- oncoct@hotmail.com
- Site Name
- Istituto Oncologico Veneto
- Department Name
- UOC Oncology 1,
- Principal Investigator Name
- Sara Lonardi
- Principal Investigator Email
- sara.lonardi@iov.veneto.it
- Contact Person Name
- Sara Lonardi
- Contact Person Email
- sara.lonardi@iov.veneto.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Katia Bruna Bencardino
- Principal Investigator Email
- katiabruna.bencardino@ospedaleniguarda.it
- Contact Person Name
- Katia Bruna Bencardino
- Contact Person Email
- katiabruna.bencardino@ospedaleniguarda.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale (duplicate?)
- Department Name
- Abdominal Oncology
- Principal Investigator Name
- Antonio Avallone
- Principal Investigator Email
- a.avallone@istitutotumori.na.it
- Contact Person Name
- Antonio Avallone
- Contact Person Email
- a.avallone@istitutotumori.na.it
- Site Name
- Casa Sollievo Della Sofferenza (duplicate?)
- Department Name
- U.O.C. di Oncologia
- Principal Investigator Name
- Tiziana Pia Latiano
- Principal Investigator Email
- t.latiano@operapadrepio.it
- Contact Person Name
- Tiziana Pia Latiano
- Contact Person Email
- t.latiano@operapadrepio.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia (duplicate?)
- Department Name
- Onclologia Medica
- Principal Investigator Name
- Maria Banzi
- Principal Investigator Email
- maria.banzi@ausl.re.it
- Contact Person Name
- Maria Banzi
- Contact Person Email
- maria.banzi@ausl.re.it
France
- Earliest CTIS Part Ii Submission Date
- 25-02-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 11
- Number Of Participants
- 48
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medicine
- Principal Investigator Name
- Michel DUCREUX
- Principal Investigator Email
- michel.ducreux@gustaveroussy.fr
- Contact Person Name
- Michel DUCREUX
- Contact Person Email
- michel.ducreux@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Frederic DI FIORE
- Principal Investigator Email
- frederic.di-fiore@chu-rouen.fr
- Contact Person Name
- Frederic DI FIORE
- Contact Person Email
- frederic.di-fiore@chu-rouen.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christelle DE LA FOUCHARDIERE
- Principal Investigator Email
- delafouchardierec@ipc.unicancer.fr
- Contact Person Name
- Christelle DE LA FOUCHARDIERE
- Contact Person Email
- delafouchardierec@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Yann TOUCHEFEU
- Principal Investigator Email
- yann.touchefeu@chu-nantes.fr
- Contact Person Name
- Yann TOUCHEFEU
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Digestive Medical Oncology
- Principal Investigator Name
- Nadim FARES
- Principal Investigator Email
- fares.n@chu-toulouse.fr
- Contact Person Name
- Nadim FARES
- Contact Person Email
- fares.n@chu-toulouse.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Amelie MALLET
- Principal Investigator Email
- amelie.mallet@ico.unicancer.fr
- Contact Person Name
- Amelie MALLET
- Contact Person Email
- amelie.mallet@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Digestive oncology
- Principal Investigator Name
- Denis SMITH
- Principal Investigator Email
- denis.smith@chu-bordeaux.fr
- Contact Person Name
- Denis SMITH
- Contact Person Email
- denis.smith@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Come LEPAGE
- Principal Investigator Email
- come.lepage@chu-bourgogne.fr
- Contact Person Name
- Come LEPAGE
- Contact Person Email
- come.lepage@chu-bourgogne.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Thierry ANDRE
- Principal Investigator Email
- thierry.andre@aphp.fr
- Contact Person Name
- Thierry ANDRE
- Contact Person Email
- thierry.andre@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Laetitia DAHAN
- Principal Investigator Email
- laetitia.dahan@ap-hm.fr
- Contact Person Name
- Laetitia DAHAN
- Contact Person Email
- laetitia.dahan@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes (duplicate?)
- Department Name
- HepatoGastroenterology
- Principal Investigator Name
- Yann TOUCHEFEU
- Principal Investigator Email
- yann.touchefeu@chu-nantes.fr
- Contact Person Name
- Yann TOUCHEFEU
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 22
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika 2. LF UK a FN Motol
- Principal Investigator Name
- Zdenek Linke
- Principal Investigator Email
- zdenek.linke@fnmotol.cz
- Contact Person Name
- Zdenek Linke
- Contact Person Email
- zdenek.linke@fnmotol.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Principal Investigator Name
- Stanislav John
- Principal Investigator Email
- stanislav.john@fnhk.cz
- Contact Person Name
- Stanislav John
- Contact Person Email
- stanislav.john@fnhk.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Onkologicka klinika
- Principal Investigator Name
- Michal Vocka
- Principal Investigator Email
- michal.vocka@vfn.cz
- Contact Person Name
- Michal Vocka
- Contact Person Email
- michal.vocka@vfn.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Klinika komplexni onkologicke pece
- Principal Investigator Name
- Jiri Tomasek
- Principal Investigator Email
- tomasek@mou.cz
- Contact Person Name
- Jiri Tomasek
- Contact Person Email
- tomasek@mou.cz
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
- Name
- Iqvia Holdings Inc.
- Responsibilities
- site payments
- Name
- Clario
- Responsibilities
- Medical image analysis/ review - X-ray, MRI, ultrasound, imaging assessment
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"site payments","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, clinical chemistry, clinical haematology, clinical microbiology, central lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO licensing and translation services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment material","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, imaging assessment","organisation_type":"Industry"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Industry"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/COA assessments","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Pharmacokinetic & biomarker services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Patient reimbursement","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- BNT327 20 mg ml
- Active Substance
- PUMITAMIG
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- prodAuthStatus 1
- Investigational Product Name
- BNT327 50 mg ml
- Active Substance
- PUMITAMIG
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- prodAuthStatus 1
- Investigational Product Name
- BEVACIZUMAB
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- CALCIUM FOLINATE
- Active Substance
- CALCIUM FOLINATE
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- IRINOTECAN HYDROCHLORIDE TRIHYDRATE
- Active Substance
- IRINOTECAN HYDROCHLORIDE TRIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- prodAuthStatus 2
- Investigational Product Name
- CAPECITABINE
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- FILM COATED TABLETS (ORAL USE)
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Combination Treatment
- Yes
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