Adjuvant Cemiplimab for Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+301 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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). 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 * To assess cemiplimab pharmacokinetics and immunogenicity in human serum

Eligibility Criteria

This trial is for adults with high-risk cutaneous squamous cell carcinoma (CSCC) who've had surgery and radiation. They should be in good physical condition, have no other cancers or significant autoimmune diseases, and their major organs must function well.

Inclusion Criteria

My skin cancer is considered high risk.

My liver, kidneys, and bone marrow are working well.

I am 21 years old or older and live in Japan.

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Exclusion Criteria

I have received immunotherapy for skin cancer.

I have been free from advanced skin cancer spread for at least 3 years.

I have a blood cancer but haven't needed treatment for it in the last 6 months.

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Treatment Details

Interventions

Cemiplimab (Monoclonal Antibodies)
Placebo ()

Trial OverviewThe study tests if Cemiplimab improves disease-free survival compared to a placebo in patients with CSCC after surgery and radiation. It also looks at overall survival, local/regional recurrence, distant recurrence, second primary tumors, safety of the drug, and its effects on the body.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CemiplimabExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention