Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.
Recruiting
Observational Study
Cutaneous Squamous Cell Carcinoma (CSCC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 30 (estimated)
- Sponsor
- Instituto de Investigación Biomédica de Salamanca · Other
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About This Trial
Cutaneous squamous cell carcinoma (CSCC) is the second most frequent cancer in humans, it exhibits a high tumor mutational burden and is more common in immunocompromised patients, which aimed to explore the impact of immunotherapy in this cancer. CSCC shows good response to anti-PD1 immunotherapy, and cemiplimab is the first FDA-approved and the only EMA-approved treatment for this tumor. However,…
Trial Locations
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Eligibility Criteria
\- Inclusion criteria At least 18 years old
Hepatic function:
1. Total bilirubin ≤1.5x upper limit of normal (ULN) (or ≤3x ULN, if liver metastases).
2. Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor
3…
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