A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06848088
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 14, 2025
Status verified
Jan 2026
Primary completion
Oct 10, 2029
Completion
Oct 10, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: With Disease Progression at Enrollment
  • Other: No Progressive Disease at Enrollment

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 ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute - West Los Angeles OfficeLos AngelesCalifornia90025-
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Henry Ford HospitalDetroitMichigan48202-
Cancer & Hematology Centers of Western MichiganGrand RapidsMichigan49546-
Sarah Cannon Research InstituteNashvilleTennessee37203-
South Texas Oncology And HematologySan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute - West Los Angeles Office· Los Angeles, CACalifornia Pacific Medical Center· San Francisco, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COHenry Ford Hospital· Detroit, MICancer & Hematology Centers of Western Michigan· Grand Rapids, MISarah Cannon Research Institute· Nashville, TN

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