Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
Eligible participants will be randomised to receive intravenous cemiplimab or a placebo for a duration of 30 minutes. The primary objective of the trial will be to compare disease-free survival between the two arms of the study.
Conditions
This trial is treating people with cutaneous squamous cell carcinoma
Eligibility
Inclusion
- For Japan only, men and women ≥21 years old
- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
- High risk CSCC, as defined in the protocol
- Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
- Adequate hepatic, renal, and bone marrow function as defined in the protocol
Exclusion
- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
- Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
- Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)
- Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
- Has had prior systemic anti-cancer immunotherapy for CSCC
Note: Other protocol defined Inclusion/Exclusion criteria apply
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Regeneron Pharmaceuticals
Scientific Title
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
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