MelanomaPhase 2NCT06848088
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
A Phase 2 study testing Fianlimab+cemiplimab in people with Melanoma, run by Regeneron Pharmaceuticals at 11 sites in 2 countries.
Trial summary
This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Fianlimab+cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 14 Apr 2025to 10 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
Who cannot join
- None
- Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States10 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Henry Ford Hospital
Detroit, Michigan, 48202
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, 22031
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
South Texas Oncology And Hematology
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94115
University of Kansas Hospital
Westwood, Kansas, 66205
About this study
Official title: Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).
The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).
- Conditions
- Melanoma
- Being tested
- Fianlimab+cemiplimab
- Keywords
- Advanced Skin Cancer
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fianlimab+cemiplimabDrug
Also called REGN3767, REGN2810, Libtayo®
No study drug administered in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| With Disease Progression at Enrollment | Other | Not described Receives: Drug: Fianlimab+cemiplimab |
| No Progressive Disease at Enrollment | Other | Not described Receives: Drug: Fianlimab+cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Measured: Up to 4 years
Secondary outcomes (9)
Progressive-Free Survival (PFS)
Measured: Up to 4 years
Objective Response Rate (ORR)
Measured: Up to 4 years
Duration of Response (DOR)
Measured: Up to 4 years
Disease Control Rate (DCR)
Measured: Up to 4 years
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 4 years
Severity of SAEs
Measured: Up to 4 years
Incidence of treatment-related AEs
Measured: Up to 4 years
Severity of treatment-related AEs
Measured: Up to 4 years
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start14 Apr 2025
- Primary completion10 Oct 2029 (estimated)
- Study completion10 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848088
- Sponsor's protocol ID
- R3767-ONC-2466
- Other IDs
- 2024-517729-20-00
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
- ClinicalTrials.gov ID
- NCT06848088
- Acronym / sponsor ID
- R3767-ONC-2466
- Conditions
- Melanoma
- Keywords
- Advanced Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 10 Oct 2029 (estimated)
- Study completion
- 10 Oct 2029 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).
The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Disease Progression at Enrollment | Other | Drug: Fianlimab+cemiplimab |
| No Progressive Disease at Enrollment | Other | Drug: Fianlimab+cemiplimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
Key exclusion criteria (2 listed)
- None
- Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fianlimab+cemiplimabAlso: REGN3767, REGN2810, Libtayo®No study drug administered in this observational study. | Drug | No Progressive Disease at Enrollment, With Disease Progression at Enrollment |
Primary outcome
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time frame: Up to 4 years
9 secondary outcomes
Progressive-Free Survival (PFS)
Time frame: Up to 4 years
Objective Response Rate (ORR)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 4 years
Disease Control Rate (DCR)
Time frame: Up to 4 years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 years
Severity of SAEs
Time frame: Up to 4 years
Incidence of treatment-related AEs
Time frame: Up to 4 years
Severity of treatment-related AEs
Time frame: Up to 4 years
Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fianlimab+cemiplimab in people with Melanoma, run by Regeneron Pharmaceuticals at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613 (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.