A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
Melanoma
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 28 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Key Inclusion Criteria:
1\. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
Key Exclusion Criteria:
None
Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
With Disease Progression at Enrollment
Not reported in this registry record.
Drug: Fianlimab+cemiplimab
No Progressive Disease at Enrollment
Not reported in this registry record.
Drug: Fianlimab+cemiplimab
Fianlimab+cemiplimab DRUG
No study drug administered in this observational study.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Not reported in this registry record.
Secondary measures
Progressive-Free Survival (PFS)
Time frame: Up to 4 years
Not reported in this registry record.
Objective Response Rate (ORR)
Time frame: Up to 4 years
Not reported in this registry record.
Duration of Response (DOR)
Time frame: Up to 4 years
Not reported in this registry record.
Disease Control Rate (DCR)
Time frame: Up to 4 years
Not reported in this registry record.
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 years
Not reported in this registry record.
Severity of SAEs
Time frame: Up to 4 years
Not reported in this registry record.
Incidence of treatment-related AEs
Time frame: Up to 4 years
Not reported in this registry record.
Severity of treatment-related AEs
Time frame: Up to 4 years
Not reported in this registry record.
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
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (11)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
11 locations
The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, California, United StatesStatus unknown
California Pacific Medical CenterSan Francisco, California, United StatesStatus unknown
University of Colorado Anschutz Medical CampusAurora, Colorado, United StatesStatus unknown
University of Kansas HospitalWestwood, Kansas, United StatesStatus unknown
Henry Ford HospitalDetroit, Michigan, United StatesStatus unknown
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan, United StatesStatus unknown
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesStatus unknown
Sarah Cannon Research InstituteNashville, Tennessee, United StatesStatus unknown
South Texas Oncology And HematologySan Antonio, Texas, United StatesStatus unknown
Virginia Cancer Care Specialist, PCFairfax, Virginia, United StatesStatus unknown
St. Vincent's University HospitalDublin, IrelandStatus unknown
Study team and timeline
- Lead sponsor
- Regeneron Pharmaceuticals
- Study start
- Apr 14, 2025 Actual
- Primary completion
- Oct 9, 2030 Estimated
- Study completion
- Oct 9, 2030 Estimated
- First posted
- Feb 26, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026