Clinical trial • Phase II • Oncology
nivolumab for Melanoma
Phase II trial of nivolumab for Melanoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 13-09-2023
- First CTIS Authorization Date
- 16-01-2024
Trial design
open-label, comparators are route-of-administration arms: nivolumab + relatlimab fixed-dose combination subcutaneous (sc) versus the same combination intravenous (iv); and nivolumab subcutaneous (sc) versus nivolumab intravenous (iv). doses and schedules are not specified in the available record.-controlled Phase II trial across 20 sites in Greece, Italy, Spain.
- Open Label
- Yes
- Comparator
- Comparators are route-of-administration arms: nivolumab + relatlimab fixed-dose combination subcutaneous (SC) versus the same combination intravenous (IV); and nivolumab subcutaneous (SC) versus nivolumab intravenous (IV). Doses and schedules are not specified in the available record.
- Target Sample Size
- 63
Eligibility
Recruits 63 Vulnerable population selected (isVulnerablePopulationSelected=true). Participants are adults (18 years or older). Informed consent will be obtained using Main ICF documents (L1_Main ICF variants) and country-specific ICFs/patient information brochures are provided (documents in Greek, Italian, Spanish and English are present). No assent procedures for minors are indicated in the documentation..
- Pregnancy Exclusion
- (who are not pregnant or breastfeeding)
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Participants are adults (18 years or older). Informed consent will be obtained using Main ICF documents (L1_Main ICF variants) and country-specific ICFs/patient information brochures are provided (documents in Greek, Italian, Spanish and English are present). No assent procedures for minors are indicated in the documentation.
Inclusion criteria
- {"criterion_text":"- The study population will be made up of men and women (who are not pregnant or breastfeeding) 18 years of age or older that have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease. Participants must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma."}
Exclusion criteria
- {"criterion_text":"- Participants must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body’s immune system response (immunosuppressive drugs)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.","definition_or_measurement_approach":"Percentage of participants who report preferring subcutaneous (SC) administration over intravenous (IV) administration (assessed as participant-reported preference)."}
Secondary endpoints
- {"endpoint_text":"- The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.","definition_or_measurement_approach":"Assessment of adverse events (side effects) and abnormal laboratory test results occurring during the study period."}
Recruitment
- Planned Sample Size
- 63
- Recruitment Window Months
- 44
- Consent Approach
- Informed consent obtained from participants (all participants aged 18 years or older) using Main ICF documents. Country-specific subject information and informed consent forms are provided (examples: L1_Main ICF_Redacted, L1_Main ICF_GR_Redacted, L1_Main ICF and SIS_IT_Redacted). Patient-facing brochures and interview guides are available in Greek, Italian, Spanish and English.
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 82
Greece
- Earliest CTIS Part Ii Submission Date
- 28-09-2023
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 796
- Number Of Sites
- 6
- Number Of Participants
- 31
Sites
- Site Name
- Bioclinic S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Ioannis Boukovinas
- Contact Person Email
- ibouk@otenet.gr
- Site Name
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
- Department Name
- 5th Oncology
- Contact Person Name
- Theofanis Floros
- Contact Person Email
- fanis_fl@yahoo.gr
- Site Name
- Metropolitan Hospital
- Department Name
- A' Oncology Clinic
- Contact Person Name
- Dimitrios Bafaloukos
- Contact Person Email
- dimmp@otenet.gr
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Apostolos Laskarakis
- Contact Person Email
- aplaskarakis@gmail.com
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Department of Medical Oncology
- Contact Person Name
- George Lazaridis
- Contact Person Email
- georlaz@yahoo.gr
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- A' Department of Medicine
- Contact Person Name
- Helen Gogas
- Contact Person Email
- helgogas@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 30-11-2023
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 754
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia clinica e sperimentale, Immunoterapia e Tumori rari
- Contact Person Name
- Laura Ridolfi
- Contact Person Email
- Laura.ridolfi@irst.emr.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Oncologia Medica del Melanoma, Sarcomi e Tumori rari
- Contact Person Name
- Carolina Cimminiello
- Contact Person Email
- carolina.cimminiello@ieo.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Sarcomi e Tumori Rari
- Contact Person Name
- Virginia Ferraresi
- Contact Person Email
- virginia.ferraresi@ifo.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Oncoematologia
- Contact Person Name
- Teresa Troiani
- Contact Person Email
- teresa.troiani@unicampania.it
- Site Name
- Azienda Ospedaliera Papa Giovanni XXIII
- Department Name
- Oncologia
- Contact Person Name
- Barbara Merelli
- Contact Person Email
- bmerelli@asst-pg23.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia 2
- Contact Person Name
- Jacopo Pigozzo
- Contact Person Email
- jacopo.pigozzo@iov.veneto.it
- Site Name
- Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
- Department Name
- Dermatologia U
- Contact Person Name
- Pietro Quaglino
- Contact Person Email
- pietro.quaglino@unito.it
Spain
- Earliest CTIS Part Ii Submission Date
- 30-11-2023
- Latest Decision Or Authorization Date
- 05-01-2026
- Processing Time Days
- 767
- Number Of Sites
- 7
- Number Of Participants
- 31
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology Service
- Contact Person Name
- Andrés Barba
- Contact Person Email
- abarba@santpau.cat
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Medical Oncology Service
- Contact Person Name
- Pablo Ayala
- Contact Person Email
- pabloayala2003@gmail.com
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Oncolgy Service
- Contact Person Name
- José Luis Manzano
- Contact Person Email
- jmanzano@iconcologia.net
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Medical Oncology Service
- Contact Person Name
- Laura Jimenez
- Contact Person Email
- ljcolomo@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncolgy Service
- Contact Person Name
- Pilar Sancho
- Contact Person Email
- sanchomarquez@hotmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Medical Oncology Service
- Contact Person Name
- Pablo Cerezuela
- Contact Person Email
- pcerezuelaf@seom.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Medical Oncolgy Service
- Contact Person Name
- Marta Sotelo
- Contact Person Email
- m.sotelogarcia@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Qualitative interview services
- Name
- Parexel International Corp.
- Name
- Fortrea Inc.
Third parties
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"COA harmonization and translations","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Qualitative interview services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Fortrea Development Ltd. Branch Of Foreign Company","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- OPDIVO 10 mg/mL concentrate for solution for infusion.
- Active Substance
- nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketingAuthorisation: EU/1/15/1014/002)
- Investigational Product Name
- Nivolumab Subcutaneous
- Active Substance
- nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus:1
- Investigational Product Name
- Nivolumab/Relatlimab
- Active Substance
- nivolumab, relatlimab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus:1
- Investigational Product Name
- FDC Nivolumab + Relatlimab + rHuPH20 Injection
- Active Substance
- nivolumab, relatlimab (and rHuPH20)
- Modality
- Monoclonal antibody|Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus:1
- Combination Treatment
- Yes
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