Clinical trial · Observational
CemiplimAb Survivorship Epidemiology
Cemiplimab Survivorship Epidemiology (CASE) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objectives of the study are: * To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) basal cell carcinoma (BCC) in real-world clinical settings * To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings * To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC * To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab * To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting * To describe real-world use patterns of cemiplimab for CSCC and BCC * To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC * To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data * To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cemiplimab | Drug | Cemiplimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC.
- interventionNames
- Drug: cemiplimab
- label
- Group 2
- description
- This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.
- interventionNames
- Drug: cemiplimab
Primary outcomes (12)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 36 months
- description
- The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol Key Exclusion Criteria: * Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC * Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study * Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up) Note: Other protocol defined Inclusion/Exclusion Criteria apply
References
Publications (2)
- DERIVEDPark SJ, Ellison DM, Weight R, Homsi J, Rabinowits G, Ruiz ES, Strasswimmer J, Simmons J, Panella T, Quek RG, Pouliot JF, Khushalani NI. CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma. Future Oncol. 2025 Feb;21(4):431-436. doi: 10.1080/14796694.2024.2448416. Epub 2025 Jan 11. PMID 39797702
- DERIVEDMigden MR, Chandra S, Rabinowits G, Chen CI, Desai J, Seluzhytsky A, Sasane M, Campanelli B, Chen Z, Freeman ML, Ibrahim SF, Khushalani NI, Andria M, Ruiz E. CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Future Oncol. 2020 Feb;16(4):11-19. doi: 10.2217/fon-2019-0762. Epub 2020 Jan 17. PMID 31951149