A Study to Evaluate Cemiplimab Survivorship Epidemiology
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-008337
NCT ID: NCT03836105
Sponsor Protocol Number: R2810-ONC-1806
About this study
The primary purpose of this study is to identify potential determinants of disease progression, Quality of Life (QOL), and other health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab. In addition, the study will aim to assess patient experience, including QOL and functional status, to identify and describe long-term effects of treatment of patients with CSCC, to collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants, to describe patients who receive cemiplimab as treatment for CSCC in a real-world setting, to describe real-world use patterns of cemiplimab for CSCC, to assess the long-term effectiveness of cemiplimab in CSCC patients in a real-world setting, to assess the effectiveness of cemiplimab as a first-line or later systemic treatment in patients with Advanced and metastatic cutaneous squamous cell carcinoma (aCSCC), regardless of etiology, to assess the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with a CSCC, regardless of etiology, to assess the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Receiving treatment with cemiplimab for CSCC, or initiating treatment with cemiplimab for CSCC.
Exclusion Criteria:
- Receiving cemiplimab for an indication other than CSCC.
- Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study.
- Note: Other protocol defined Inclusion/Exclusion Criteria apply.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Roxana Dronca, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available