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

Study Details

Primary objective: 

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).

Secondary objectives:

1. To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
2. To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
3. To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
4. To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
5. To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT

Key Inclusion Criteria:

1. 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
2. High risk CSCC, as defined in the protocol
3. Completion of curative intent post-operative radiation therapy (RT) within 2 to 6 weeks of randomization
4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
5. Adequate hepatic, renal, and bone marrow function as defined in the protocol

Key Exclusion Criteria:

1. Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
2. 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
3. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
4. 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)
5. 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.
6. Has had prior systemic anti-cancer immunotherapy for CSCC
7. Note: Other protocol defined Inclusion/Exclusion criteria apply