A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04315701
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Skin Squamous Cell Carcinoma
  • Resectable Skin Squamous Cell Carcinoma
  • Stage I Skin Cancer
  • Stage II Skin Cancer
  • Stage III Skin Cancer

Eligibility Criteria

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

Interventions

  • Cemiplimab — BIOLOGICAL
    Given IV
  • Resection — PROCEDURE
    Undergo surgical resection

Study Details

This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). 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.

Key Dates

Start date
Jun 17, 2020
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cemiplimab, surgical resection)
    Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

Primary Outcome Measure

Confirmed pathologic partial response [ Time Frame: Up to 24 months after completion of study treatment ]

Locations (5)

FacilityCityStateZIPSite coordinators
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Hoag Memorial HospitalNewport BeachCalifornia92663-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
University of NebraskaOmahaNebraska68198-

Find similar trials in Los Angeles, CA

By research site
Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAHoag Memorial Hospital· Newport Beach, CANorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Nebraska· Omaha, NE

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