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Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

NCT04428671 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-14

No results posted yet for this study

Summary

This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.

Conditions

  • Metastatic Skin Squamous Cell Carcinoma
  • Recurrent Skin Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Cemiplimab

Given IV

RADIATION

Radiation Therapy

Undergo standard of care radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo standard of care surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Michael Lowe, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2030-10-01
Completion
2031-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428671 on ClinicalTrials.gov