Clinical trial • Phase III • Oncology
SPARTALIZUMAB for Advanced cancer | Solid tumor | Malignant neoplasm
Phase III trial of SPARTALIZUMAB for Advanced cancer | Solid tumor | Malignant neoplasm. open-label. 44 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced cancer | Solid tumor | Malignant neoplasm
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule | Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 14-02-2024
- First CTIS Authorization Date
- 22-03-2024
Trial design
open-label Phase III trial across 28 sites in Czechia, France, Poland and others.
- Open Label
- Yes
- Target Sample Size
- 44
- Trial Duration For Participant
- 533
Eligibility
Recruits 44 Vulnerable populations are selected (isVulnerablePopulationSelected: true). Signed informed consent must be obtained prior to participation. Multiple subject information and informed consent forms (ICFs) are provided in several languages. No explicit details on assent or age‑specific consent procedures are provided in the record..
- Vulnerable Population
- Vulnerable populations are selected (isVulnerablePopulationSelected: true). Signed informed consent must be obtained prior to participation. Multiple subject information and informed consent forms (ICFs) are provided in several languages. No explicit details on assent or age‑specific consent procedures are provided in the record.
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study.\n- Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment.\n- Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.\n- Subject has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.\n- Subject is willing and able to comply with the scheduled visits and treatment plans."}
Exclusion criteria
- {"criterion_text":"- Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the CPDR001X2X01B study.\n- Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the frequency and nature of adverse events (AEs) and serious adverse events (SAE), as well as subjects with dose interruptions and dose reductions.","definition_or_measurement_approach":"Measure and report the frequency and nature of AEs and SAEs and count subjects who experience dose interruptions and dose reductions (i.e. incidence counts and descriptive characterisation of AEs/SAEs and numbers of subjects with dose interruptions/reductions)."}
Secondary endpoints
- {"endpoint_text":"- Number of subjects receiving spartalizumab as single agent or in combination with other study treatments and duration of exposure","definition_or_measurement_approach":"Count of subjects receiving spartalizumab (monotherapy or combination) and measurement of duration of exposure (time on treatment/exposure duration per subject)."}
Recruitment
- Planned Sample Size
- 44
- Recruitment Window Months
- 125
- Consent Approach
- Signed informed consent must be obtained from participants prior to participation. Multiple ICF documents are provided (Main ICF - Adult versions and related ICFs) in multiple languages including Polish, Spanish, Hungarian, German, Italian, French, English, Dutch and Czech. There are also specific ICFs for pregnant participants and partner information sheets. No explicit assent procedures or age‑specific consent handling are described in the available record.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 75
Czechia
- Latest Decision Or Authorization Date
- 27-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- 6302: Masarykuv Onkologicky Ustav
- Contact Person Name
- Peter Grell
- Contact Person Email
- grell@mou.cz
France
- Latest Decision Or Authorization Date
- 27-03-2024
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- 7007: Medical Oncology
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Institut Paoli-Calmettes
- Department Name
- 7002: Medical Oncology
- Contact Person Name
- Patricia Niccoli
- Contact Person Email
- niccolip@ipc.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- 7001: Medical Oncology
- Contact Person Name
- Caroline Even
- Contact Person Email
- caroline.even@gustaveroussy.fr
- Site Name
- Hopital Huriez
- Department Name
- 7006: Medical Oncology
- Contact Person Name
- Stephane Cattan
- Contact Person Email
- stephane.cattan@chru-lille.fr
- Site Name
- Centre Leon Berard
- Department Name
- 7004: Medical Oncology
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
Poland
- Latest Decision Or Authorization Date
- 28-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- 8503
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- badania.kliniczne@medpolonia.pl
Germany
- Latest Decision Or Authorization Date
- 22-03-2024
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 7511: Klinik fuer Endokrinologie und Stoffwechselerkrankungen
- Contact Person Name
- Harald Lahner
- Contact Person Email
- Harald.lahner@uk-essen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- 7512: Klinik fuer Innere Medizin III
- Contact Person Name
- Frank Stegelmann
- Contact Person Email
- Frank.stegelmann@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- 7510: Klinik fuer Innere Medizin II
- Contact Person Name
- Thomas Ernst
- Contact Person Email
- Thomas.ernst@med.uni-jena.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 7514: National center for Tumor Diseases
- Contact Person Name
- Christoph Springfeld
- Contact Person Email
- Christoph.Springfeld@med.uni-heidelberg.de
Hungary
- Latest Decision Or Authorization Date
- 26-03-2024
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- 8303: Dermatoonkologiai Osztaly
- Contact Person Name
- Gabriella Liszkay
- Contact Person Email
- Liszkay@oncol.hu
- Site Name
- University Of Debrecen
- Department Name
- 8301: Onkologiai Klinika
- Contact Person Name
- Peter Arkosy
- Contact Person Email
- arkosy.peter@med.unideb.hu
- Site Name
- University Of Debrecen
- Department Name
- 8302: Borgyogyaszati Klinika
- Contact Person Name
- Eva Remenyik
- Contact Person Email
- Remenyik@med.unideb.hu
Italy
- Latest Decision Or Authorization Date
- 26-03-2024
- Number Of Sites
- 7
- Number Of Participants
- 26
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- #8001: S.C. Oncologia Medica 1
- Contact Person Name
- Filippo de Braud
- Contact Person Email
- filippo.debraud@istitutotumori.mi.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- #8008: Divisione Sviluppo Nuovi Farmaci per Terapie Innovative – Oncologia Medica
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- #8009: U.O.C. Immunoterapia Oncologica
- Contact Person Name
- Michele Maio
- Contact Person Email
- maio@unisi.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- #8002: U.O. Oncologia Medica
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- Universita' Degli Studi Di Modena E Reggio Emilia
- Department Name
- #8010: S.S. Day Hospital Oncologico
- Contact Person Name
- Roberta Depenni
- Contact Person Email
- depenni.roberta@aou.mo.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- #8007: U.O.C. Melanoma, Immunoterapia Oncologica e Terapie Innovative
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- paolo.ascierto@gmail.com
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- #8006: S.C. Oncologia Medica
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
Spain
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 5
- Number Of Participants
- 22
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- #9007: Oncology
- Contact Person Name
- Marta Gil Martin
- Contact Person Email
- mgilmartin@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- #9002: Oncology
- Contact Person Name
- Sara López Tarruella Cobo
- Contact Person Email
- sara.lopeztarruella@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #9001: Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- #9006: Oncology
- Contact Person Name
- Ana Maria Arance Fernandez
- Contact Person Email
- amarance@clinic.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- #9005: Oncology
- Contact Person Name
- Desamparados Roda Perez
- Contact Person Email
- droda@incliva.es
Belgium
- Latest Decision Or Authorization Date
- 02-04-2024
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- UZ Leuven
- Department Name
- 6001: Medical Oncology
- Contact Person Name
- Patrick Schöffski
- Contact Person Email
- patrick.schoffski@uzleuven.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- 6002: Medical Oncology
- Contact Person Name
- Pierre Frères
- Contact Person Email
- pfreres@chuliege.be
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes present (no descriptive text provided)
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes present (no descriptive text provided)
- Name
- Syneos Health Clinical Spain S.L.
- Responsibilities
- sponsorDuties codes present (no descriptive text provided)
- Name
- IQVIA RDS Spain S.L.
- Responsibilities
- sponsorDuties codes present (no descriptive text provided)
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive Activation sites activities","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Syneos Health Clinical Spain S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"Local drug supply Local equipment storage","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Patient compensation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Czechia","full_name":"Movianto Ceska republika s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Local distribution and destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PDR001
- Active Substance
- SPARTALIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- Authorised
- Maximum Dose
- 400 mg
- Investigational Product Name
- TRAMETINIB DIMETHYL SULFOXIDE (TMT212)
- Active Substance
- TRAMETINIB DIMETHYL SULFOXIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg
- Investigational Product Name
- DABRAFENIB MESYLATE
- Active Substance
- DABRAFENIB MESYLATE
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Not Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 300 mg
- Investigational Product Name
- LAG525
- Active Substance
- IERAMILIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- Authorised
- Maximum Dose
- 800 mg
- Investigational Product Name
- MCS110
- Active Substance
- LACNOTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- Authorised
- Maximum Dose
- 7.5 mg/kg
- Investigational Product Name
- NIZ985
- Active Substance
- HETERODIMERIC INTERLEUKIN-15
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Maximum Dose
- 12 µg/Kg
- Investigational Product Name
- CANAKINUMAB
- Active Substance
- CANAKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Not Authorised
- Maximum Dose
- 600 mg
- Investigational Product Name
- LXH254
- Active Substance
- NAPORAFENIB
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 800 mg
- Investigational Product Name
- NIR178
- Active Substance
- TAMINADENANT
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 480 mg
- Investigational Product Name
- INC280
- Active Substance
- CAPMATINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 600 mg
- Investigational Product Name
- DKY709
- Active Substance
- 3-[6-(1-BENZYLPIPERIDIN-4-YL)-3-OXO-1H-ISOINDOL-2-YL]PIPERIDINE-2,6-DIONE
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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