Clinical trial • Phase II/III • Oncology
NIVOLUMAB for Metastatic melanoma | Unresectable melanoma
Phase II/III trial of NIVOLUMAB for Metastatic melanoma | Unresectable melanoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic melanoma | Unresectable melanoma
- Trial Stage
- Phase II/III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 12-03-2024
- First CTIS Authorization Date
- 10-04-2024
Trial design
Randomised, relatlimab combined with nivolumab (investigational combination) versus nivolumab monotherapy (comparator arm, opdivo 10 mg/ml). dose and schedule not specified in the provided record.-controlled Phase II/III trial in Norway, Denmark, Sweden and others.
- Randomised
- Yes
- Comparator
- Relatlimab combined with Nivolumab (investigational combination) versus Nivolumab monotherapy (comparator arm, OPDIVO 10 mg/mL). Dose and schedule not specified in the provided record.
- Biomarker Stratified
- True, biomarker: LAG-3 expression and PD-L1 status (subgroups defined by combinations of LAG-3 expression and PD-L1 status)
- Target Sample Size
- 660
Stratification factors
- LAG-3 expression
- PD-L1 status
Eligibility
Recruits 660 paediatric patients.
- Vulnerable Population
- Vulnerable population selected. Consent materials and assent forms are provided (documents include adult, parent and assent ICF versions in multiple countries/languages). Parental consent and participant assent procedures are referenced (e.g., documents named "Main_adult_parent" and "Main_assent" for France and other country-specific ICFs), indicating minors are handled via parental consent and assent forms as appropriate.
Inclusion criteria
- {"criterion_text":"- Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system"}
- {"criterion_text":"- Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma"}
- {"criterion_text":"- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses"}
Exclusion criteria
- {"criterion_text":"- Participants must not have active brain metastases or leptomeningeal metastases"}
- {"criterion_text":"- Participants must not have uveal melanoma"}
- {"criterion_text":"- Participants must not have an active, known, or suspected autoimmune disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Assessed by a Blinded Independent Central Review (BICR); PFS defined as time from randomization to first documented disease progression or death from any cause."}
- {"endpoint_text":"- PFS Phase 2 portion of trial, assessed by a BICR","definition_or_measurement_approach":"Assessed by a Blinded Independent Central Review (BICR); PFS (as above) measured using RECIST v1.1 per BICR."}
Secondary endpoints
- {"endpoint_text":"- Phase 3 portion of trial: Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}
- {"endpoint_text":"- Phase 3 portion of trial: ORR , assessed by a BICR","definition_or_measurement_approach":"Objective response rate assessed by Blinded Independent Central Review (BICR) using RECIST v1.1."}
- {"endpoint_text":"- Phase 2 portion of trial: ORR , assessed by a BICR. In the randomized population and in subgroups","definition_or_measurement_approach":"Objective response rate assessed by BICR (RECIST v1.1) in randomized population and specified biomarker subgroups."}
- {"endpoint_text":"- Phase 2 portion of trial: Duration of Response (DOR) in the randomized population and in subgroups","definition_or_measurement_approach":"Duration of response per BICR/RECIST v1.1 in randomized population and subgroups."}
- {"endpoint_text":"- Phase 2 portion of trial: PFS in subgroups","definition_or_measurement_approach":"Progression-free survival measured by BICR/RECIST v1.1 in pre-specified subgroups."}
- {"endpoint_text":"- Phase 2 portion of trial: OS in the randomized population and in subgroups","definition_or_measurement_approach":"Overall survival in randomized population and subgroups."}
- {"endpoint_text":"- Phase 2 portion of the trial: Number of Adverse Events (AEs)","definition_or_measurement_approach":"Count of adverse events as reported in trial safety data."}
- {"endpoint_text":"- Phase 2 portion of the trial: Number of Serious Adverse Events (SAEs)","definition_or_measurement_approach":"Count of serious adverse events as reported in trial safety data."}
- {"endpoint_text":"- Phase 2 portion of the trial: Number of AEs Leading to Discontinuation","definition_or_measurement_approach":"Count of adverse events that resulted in treatment discontinuation."}
- {"endpoint_text":"- Phase 2 portion of the trial: Number of Deaths","definition_or_measurement_approach":"Count of deaths occurring during the study period."}
- {"endpoint_text":"- Phase 2 portion of the trial: Number of Laboratory Abnormalities","definition_or_measurement_approach":"Count of laboratory abnormalities (clinically significant) observed during the trial."}
Recruitment
- Planned Sample Size
- 660
- Recruitment Window Months
- 152
- Consent Approach
- Informed consent is managed with country-specific subject information sheets and informed consent forms. Documents include adult ICFs, parent/guardian ICFs and assent forms (e.g., files named 'Main_adult_parent', 'Main_assent' and country-specific addenda). ICFs and addenda are available in multiple languages corresponding to participating countries (examples: DE, FR, ES, IT, PL, BE/NL, SE etc.). Specific optional consent components (optional biopsy, treatment beyond progression, pregnant partner information) are provided as separate ICF addenda where applicable.
Geography
- Total Number Of Sites
- 47
- Total Number Of Participants
- 340
Norway
- Earliest CTIS Part Ii Submission Date
- 10-04-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 693
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Principal Investigator Name
- Anna Winge-Main
- Principal Investigator Email
- annwi@ous-hf.no
- Contact Person Name
- Anna Winge-Main
- Contact Person Email
- annwi@ous-hf.no
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 11-04-2026
- Processing Time Days
- 691
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Oncology
- Principal Investigator Name
- Inge Marie Svane
- Principal Investigator Email
- inge.marie.svane@regionh.dk
- Contact Person Name
- Inge Marie Svane
- Contact Person Email
- inge.marie.svane@regionh.dk
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 692
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Klinisk Prövningsenhet, Verksamhetsområde Onkologi, Blå stråket 2 413 45 Göteborg
- Principal Investigator Name
- Lars Ny
- Principal Investigator Email
- lars.ny@oncology.gu.se
- Contact Person Name
- Lars Ny
- Contact Person Email
- lars.ny@oncology.gu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematologimottagningen Lasarettsgatan 23A Plan 2 221 85 Lund
- Principal Investigator Name
- Ana Carneiro
- Principal Investigator Email
- ana.carneiro@med.lu.se
- Contact Person Name
- Ana Carneiro
- Contact Person Email
- ana.carneiro@med.lu.se
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 689
- Number Of Sites
- 5
- Number Of Participants
- 54
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- Oncology
- Principal Investigator Name
- Cralo Alberto Tondini
- Principal Investigator Email
- carlo.tondini@asst-pg23.it
- Contact Person Name
- Cralo Alberto Tondini
- Contact Person Email
- carlo.tondini@asst-pg23.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- Oncology
- Principal Investigator Name
- Michele Maio
- Principal Investigator Email
- mmaiocro@gmail.com
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology
- Principal Investigator Name
- Jacopo Pigozzo
- Principal Investigator Email
- jacopo.pigozzo@iov.veneto.it
- Contact Person Name
- Jacopo Pigozzo
- Contact Person Email
- jacopo.pigozzo@iov.veneto.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncology
- Principal Investigator Name
- Paolo Antonio Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncology
- Principal Investigator Name
- Michele Del Vecchio
- Principal Investigator Email
- michele.delvecchio@istitutotumori.mi.it
- Contact Person Name
- Michele Del Vecchio
- Contact Person Email
- michele.delvecchio@istitutotumori.mi.it
Finland
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 692
- Number Of Sites
- 4
- Number Of Participants
- 29
Sites
- Site Name
- Turku University Hospital
- Department Name
- Department of oncology, Clinical trial unit
- Principal Investigator Name
- Pia Vihinen
- Principal Investigator Email
- pia.vihinen@varha.fi
- Contact Person Name
- Pia Vihinen
- Contact Person Email
- pia.vihinen@varha.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Comprehensive cancer center, Clinical Trial Unit
- Principal Investigator Name
- Micaela Hernberg
- Principal Investigator Email
- micaela.hernberg@hus.fi
- Contact Person Name
- Micaela Hernberg
- Contact Person Email
- micaela.hernberg@hus.fi
- Site Name
- Oulu University Hospital
- Department Name
- Department of Oncology and Radiotherapy, Oncology and hematology
- Principal Investigator Name
- Sanna Iivanainen
- Principal Investigator Email
- tutkimuspalvelut@pohde.fi
- Contact Person Name
- Sanna Iivanainen
- Contact Person Email
- tutkimuspalvelut@pohde.fi
- Site Name
- Tampere University Hospital
- Department Name
- Department of oncology, Clinical trial unit
- Principal Investigator Name
- Tanja Skyttä
- Principal Investigator Email
- clinicaltrials@pirha.fi
- Contact Person Name
- Tanja Skyttä
- Contact Person Email
- clinicaltrials@pirha.fi
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 685
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Medishe Oncologie
- Principal Investigator Name
- Celine Jacobs
- Principal Investigator Email
- poli.oncologie@uzgent.be
- Contact Person Name
- Celine Jacobs
- Contact Person Email
- poli.oncologie@uzgent.be
Romania
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 697
- Number Of Sites
- 2
- Number Of Participants
- 26
Sites
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- tudor_ciuleanu@hotmail.com
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 10-04-2024
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 695
- Number Of Sites
- 4
- Number Of Participants
- 34
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Principal Investigator Name
- Luis De la Cruz
- Principal Investigator Email
- xxxx@xxxxx
- Contact Person Name
- Luis De la Cruz
- Contact Person Email
- xxxx@xxxxx
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Ana Arance
- Principal Investigator Email
- amarance@clinic.cat
- Contact Person Name
- Ana Arance
- Contact Person Email
- amarance@clinic.cat
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Oncology
- Principal Investigator Name
- Eva Muñoz
- Principal Investigator Email
- emunoz@vhio.net
- Contact Person Name
- Eva Muñoz
- Contact Person Email
- emunoz@vhio.net
- Site Name
- Fundacion Onkologikoa Fundazioa
- Department Name
- Oncology
- Principal Investigator Name
- Karmele Mujika
- Principal Investigator Email
- kmujika@onkologikoa.org
- Contact Person Name
- Karmele Mujika
- Contact Person Email
- kmujika@onkologikoa.org
Poland
- Earliest CTIS Part Ii Submission Date
- 12-04-2024
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 694
- Number Of Sites
- 3
- Number Of Participants
- 38
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
- Principal Investigator Name
- Jacek Mackiewicz
- Principal Investigator Email
- jmackiewicz@ump.edu.pl
- Contact Person Name
- Jacek Mackiewicz
- Contact Person Email
- jmackiewicz@ump.edu.pl
- 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
- piotr.rutkowski@nio.gov.pl
- Contact Person Name
- Piotr Rutkowski
- Contact Person Email
- piotr.rutkowski@nio.gov.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
- Principal Investigator Name
- Jacek Mackiewicz
- Principal Investigator Email
- ucwbk@ump.edu.pl
- Contact Person Name
- Jacek Mackiewicz
- Contact Person Email
- ucwbk@ump.edu.pl
Austria
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 689
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Peter Michael Rohrer
- Principal Investigator Email
- peter.rohrer@medunigraz.at
- Contact Person Name
- Peter Michael Rohrer
- Contact Person Email
- peter.rohrer@medunigraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- Dermatology
- Principal Investigator Name
- Christoph Höller
- Principal Investigator Email
- christoph.hoeller@meduniwien.ac.at
- Contact Person Name
- Christoph Höller
- Contact Person Email
- christoph.hoeller@meduniwien.ac.at
- Site Name
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
- Department Name
- Dermatology
- Principal Investigator Name
- Peter Kölblinger
- Principal Investigator Email
- p.koelblinger@salk.at
- Contact Person Name
- Peter Kölblinger
- Contact Person Email
- p.koelblinger@salk.at
Greece
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 654
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Internal Medicine- Oncology Clinic
- Principal Investigator Name
- Helen Gogas
- Principal Investigator Email
- helgogas@gmail.com
- Contact Person Name
- Helen Gogas
- Contact Person Email
- helgogas@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 690
- Number Of Sites
- 8
- Number Of Participants
- 44
Sites
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Service 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
- Hopital Saint Louis
- Department Name
- Polyclinique de Dermatologie
- Principal Investigator Name
- Céleste LEBBE
- Principal Investigator Email
- celeste.lebbe@sls.aphp.fr
- Contact Person Name
- Céleste LEBBE
- Contact Person Email
- celeste.lebbe@sls.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Clinique 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
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- Ewa WIERZBICKA-HAINAUT
- Principal Investigator Email
- ewa.hainaut@chu-poitiers.fr
- Contact Person Name
- Ewa WIERZBICKA-HAINAUT
- Contact Person Email
- ewa.hainaut@chu-poitiers.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service 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 Universitaire De Bordeaux
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Caroline DUTRIAUX
- Principal Investigator Email
- caroline.dutriaux@chu-bordeaux.fr
- Contact Person Name
- Caroline DUTRIAUX
- Contact Person Email
- caroline.dutriaux@chu-bordeaux.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Service Oncologie Médicale
- Principal Investigator Name
- Marc PRACHT
- Principal Investigator Email
- m.pracht@rennes.unicancer.fr
- Contact Person Name
- Marc PRACHT
- Contact Person Email
- m.pracht@rennes.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Service Dermatologie
- Principal Investigator Name
- Jean-Philippe ARNAULT
- Principal Investigator Email
- arnault.jean-philippe@chu-amiens.fr
- Contact Person Name
- Jean-Philippe ARNAULT
- Contact Person Email
- arnault.jean-philippe@chu-amiens.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 689
- Number Of Sites
- 12
- Number Of Participants
- 64
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Dermatologie, Allergologie und Venerologie
- Principal Investigator Name
- Imke Wasielewski
- Principal Investigator Email
- vonwasielewski.imke@mh-hannover.de
- Contact Person Name
- Imke Wasielewski
- Contact Person Email
- vonwasielewski.imke@mh-hannover.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Innere Medizin III
- Principal Investigator Name
- Folker Schneller
- Principal Investigator Email
- folker.schneller@tum.de
- Contact Person Name
- Folker Schneller
- Contact Person Email
- folker.schneller@tum.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Anja Gesierich
- Principal Investigator Email
- gesierich_a@ukw.de
- Contact Person Name
- Anja Gesierich
- Contact Person Email
- gesierich_a@ukw.de
- Site Name
- HELIOS Klinikum Erfurt GmbH
- Department Name
- Klinik für Hautkrankheiten und Allergologie
- Principal Investigator Name
- Rudolf Alexander Herbst
- Principal Investigator Email
- rudolf.v@helios-gesundheit.de
- Contact Person Name
- Rudolf Alexander Herbst
- Contact Person Email
- rudolf.v@helios-gesundheit.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- 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
- University Hospital Cologne AöR
- Department Name
- Dermatologie und Venerologie
- Principal Investigator Name
- Cindy Franklin
- Principal Investigator Email
- cindy.franklin@uk-koeln.de
- Contact Person Name
- Cindy Franklin
- Contact Person Email
- cindy.franklin@uk-koeln.de
- Site Name
- Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
- Department Name
- Dermato- Onkologie
- Principal Investigator Name
- Peter Mohr
- Principal Investigator Email
- peter.mohr@elbekliniken.de
- Contact Person Name
- Peter Mohr
- Contact Person Email
- peter.mohr@elbekliniken.de
- Site Name
- Universitat Heidelberg
- Department Name
- Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Jochen Sven Utikal
- Principal Investigator Email
- jochen.utikal@umm.de
- Contact Person Name
- Jochen Sven Utikal
- Contact Person Email
- jochen.utikal@umm.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Zentrum für Dermatologie und Onkologie
- Principal Investigator Name
- Ulrike Leiter- Stöppke
- Principal Investigator Email
- ulrike.leiter@med.uni-tuebingen.de
- Contact Person Name
- Ulrike Leiter- Stöppke
- Contact Person Email
- ulrike.leiter@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- NCT / Hauttumorzentrum Heidelberg
- Principal Investigator Name
- Jessica Hassel
- Principal Investigator Email
- jessica.hassel@med.uni-heidelberg.de
- Contact Person Name
- Jessica Hassel
- Contact Person Email
- jessica.hassel@med.uni-heidelberg.de
- Site Name
- Harzklinikum Dorothea Christiane Erxleben GmbH
- Department Name
- Dermatologie und Allergologie
- Principal Investigator Name
- Florian Joithe
- Principal Investigator Email
- florian.joithe@harzklinikum.com
- Contact Person Name
- Florian Joithe
- Contact Person Email
- florian.joithe@harzklinikum.com
- Site Name
- Medizinische Hochschule Hannover (additional listed site record)
- Department Name
- Dermatologie, Allergologie und Venerologie
- Principal Investigator Name
- Imke Wasielewski
- Principal Investigator Email
- vonwasielewski.imke@mh-hannover.de
- Contact Person Name
- Imke Wasielewski
- Contact Person Email
- vonwasielewski.imke@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Bioclinica Inc.
- Responsibilities
- Collect de-identified images; Imaging documentation development; independent reader training; analysis data & images transfer; archive
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- Data entry of Local Laboratory Values
- Name
- Q2 Solutions
- Responsibilities
- Sample management, kit building, storage and distribution of samples to other vendors for analysis
Third parties
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Collect de-identified images;Imaging doc dev;Indip Rder training;anlysis data&images trasfer;archive","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"submission administrative support","organisation_type":"SME"}
- {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Immunohistochemistry (IHC) Biomarker expression analysis (PD-L1)","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"SME"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- OPDIVO 10 mg/mL concentrate for solution for infusion.
- Active Substance
- NIVOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation EU/1/15/1014/002
- Maximum Dose
- 480 mg (max daily dose)
- Investigational Product Name
- Nivolumab/Relatlimab
- Active Substance
- NIVOLUMAB, RELATLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Combination Treatment
- Yes
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