Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
98
Countries
1
Sites
1
Melanoma
Assess Overall Survival (OS)
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-07-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Regeneron Pharmaceuticals Inc.
External identifiers
- EU CT number
- 2024-517729-20-00
- ClinicalTrials.gov
- NCT06848088
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Assess Overall Survival (OS)
Secondary objectives 6
- Assess Progression-Free Survival (PFS)
- Assess Objective Response Rate (ORR)
- Assess Duration of Response (DOR)
- Assess Disease Control Rate (DCR) and CR
- Assess long-term safety
- Concomitant medications
Conditions and MedDRA coding
Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613.
Exclusion criteria 1
- None
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Secondary endpoints 9
- Progressive-Free Survival (PFS)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Disease Control Rate (DCR)
- Incidence of Serious Adverse Events (SAEs)
- Severity of SAEs
- Incidence of treatment-related AEs
- Severity of treatment-related AEs
- Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7478447 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF06 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10082279 · Product
- Active substance
- Fianlimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Radmd LLC ORG-100044816
|
Conshohocken, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 13, Code 14, Code 2, Code 5, Code 8 |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Authorised, recruitment pending | 45 | 1 |
| Rest of world
United States
|
— | 53 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517729-20-00_redacted | 1 |
| Recruitment arrangements (for publication) | K1_R3767-ONC-2466_Recruit arrang_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R3767-ONC-2466_SIS-ICF_Main_FP | 2.0 |
| Synopsis of the protocol (for publication) | D1_Plain Language Protocol synopsis_2024-517729-20-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-20 | Ireland | Acceptable 2025-07-04
|
2025-07-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-15 | Ireland | Acceptable 2026-06-02
|
2026-06-02 |