Clinical trial • Phase IV|Phase II • Oncology
CEMIPLIMAB for Melanoma
Phase IV|Phase II trial of CEMIPLIMAB for Melanoma. None/Not specified-controlled. 53 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma
- Trial Stage
- Phase IV|Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 20-03-2025
- First CTIS Authorization Date
- 04-07-2025
Trial design
None/Not specified-controlled Phase IV|Phase II trial across 1 site in Ireland.
- Comparator
- None/Not specified
- Target Sample Size
- 53
- Trial Duration For Participant
- 1645
Eligibility
Recruits 53 Vulnerable population selected; no details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the record.
Inclusion criteria
- {"criterion_text":"- Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613."}
Exclusion criteria
- {"criterion_text":"- None"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Progressive-Free Survival (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Objective Response Rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Disease Control Rate (DCR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of Serious Adverse Events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Severity of SAEs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment-related AEs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Severity of treatment-related AEs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 53
- Recruitment Window Months
- 54
- Consent Approach
- Informed consent referenced (subject information and informed consent form listed) but specific details on who provides consent, assent process, age-specific documents, or available languages are not provided in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 53
Ireland
- Earliest CTIS Part Ii Submission Date
- 09-06-2025
- Latest Decision Or Authorization Date
- 04-07-2025
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 45
Sites
- Site Name
- St Vincent's University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- John Crown
- Principal Investigator Email
- john.crown@ccrt.ie
- Contact Person Name
- John Crown
- Contact Person Email
- john.crown@ccrt.ie
- Number Of Participants
- 45
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
- codes: 1,13,14,2,5,8
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,13,14,2,5,8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Participant retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Radmd LLC","duties_or_roles":"Medical Imaging","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- LIBTAYO 350 mg concentrate for solution for infusion.
- Active Substance
- CEMIPLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/19/1376/001)
- Investigational Product Name
- Fianlimab
- Active Substance
- FIANLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised / Investigational (no marketing authorisation listed)
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