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RecruitingLast updated: 11 October 2023

This phase III trial is comparing survival outcomes for patients with high-risk cutaneous squamous cell carcinoma who are treated with adjuvant immunotherapy (cemiplimab), compared to those who are treated with a placebo, after surgery and radiotherapyA 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

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 patients with cutaneous squamous cell carcinoma

Cancer

Skin Cancers Skin

Age

People18+

Phase

III

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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