Long-term Effects of Fianlimab and Cemiplimab in Advanced Melanoma
Fianlimab+cemiplimab
Melanoma+9
+ Neoplasms
+ Neoplasms by Histologic Type
Other Study
Summary
Study start date: April 14, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding the long-term safety and effectiveness of two experimental drugs, fianlimab and cemiplimab, in individuals with advanced melanoma, a serious form of skin cancer. Participants in this study have previously been treated with these drugs in an earlier study. The research aims to gather information on how these drugs impact the health of patients over a longer period, which can help improve future treatment strategies and provide better care for melanoma patients. During this study, participants will not receive any new doses of fianlimab or cemiplimab. Instead, their health will be closely monitored to observe the status of their cancer and gather data on their overall well-being. The study will also collect details about any other treatments participants might have received after the previous study. This approach helps researchers evaluate the lasting effects of the drugs without introducing new interventions, ensuring a focus on long-term health outcomes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, United StatesOpen The Angeles Clinic and Research Institute - West Los Angeles Office in Google MapsCalifornia Pacific Medical Center
San Francisco, United StatesUniversity of Colorado Anschutz Medical Campus
Aurora, United StatesHenry Ford Hospital
Detroit, United States