A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fianlimab+cemiplimab.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
Overview
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).
Interventions
- Drug Fianlimab+cemiplimab
No study drug administered in this observational study.
Primary outcome 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]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
1\. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)
Exclusion criteria
None
Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 10 centers
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles
- California Pacific Medical Center — San Francisco
- University of Colorado Anschutz Medical Campus — Aurora
- University of Kansas Hospital — Westwood
- Henry Ford Hospital — Detroit
- Cancer & Hematology Centers of Western Michigan — Grand Rapids
- Rutgers Cancer Institute of New Jersey — New Brunswick
- Sarah Cannon Research Institute — Nashville
- … and 2 more centers
Ireland · 1 center
- St. Vincent's University Hospital — Dublin
Identifiers
NCT: NCT06848088 · R3767-ONC-2466 · 2024-517729-20-00