Clinical Trial 20068

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03969004

Phase: Phase III
Principal Investigator: Khushalani, Nikhil

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Overview

Study 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

Summary

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).

Objective

The primary objective of the study is to compare DFS of patients with high-risk CSCC treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT. Secondary Objectives The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients freedom from distant recurrence (FFDR) after surgery and RT - 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 - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT

Treatments

Therapies

Immunotherapy

Medications

Cemiplimab (); Placebo (); REGN2810 (Cemiplimab)

Inclusion Criteria

Participant 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 6 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 Criteria

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

Participants with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))

Participants 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

Other protocol defined Inclusion/Exclusion criteria apply

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