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Adjuvant Cemiplimab for Squamous Cell Carcinoma

Phase 3

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status (ECOG PS) ≤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

Must not have

Has had prior systemic anti-cancer immunotherapy for CSCC

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing if a drug called cemiplimab can help people with high-risk cutaneous squamous cell carcinoma (CSCC) live longer without their cancer coming back.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of Cemiplimab may include immune-related reactions due to it being an immunotherapy drug. These can range from mild skin conditions to more serious organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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I had surgery to remove skin cancer that was confirmed by a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received immunotherapy for skin cancer.

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I have no other cancers besides localized CSCC or any cancer in the last 3 years.

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My cancer is a squamous cell type but not of the skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.

Secondary study objectives

FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.

Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.