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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04428671
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo standard of care radiation therapy
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo standard of care surgery

Study Details

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.

Key Dates

Start date
May 15, 2020
Status verified
Aug 2025
Primary completion
Oct 1, 2030
Completion
Oct 1, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cemiplimab)
    NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Pathologic response rate [ Time Frame: From screening up to 10 years post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University/Winship Cancer InstituteAtlantaGeorgia30322
Allyson R. Anderson
[email protected]
404-251-2854
Michael Lowe, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University/Winship Cancer Institute· Atlanta, GA

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