Study on Pembrolizumab for High-Risk Cutaneous Squamous Cell Carcinoma Before Surgery

Sponsor: Diwakar Davar

Sponsor score: 0

ClinicalTrials ID:NCT04808999

Provider View

This clinical trial is testing the use of pembrolizumab, a PD-1 inhibitor, in patients with high-risk cutaneous squamous cell carcinoma (cSCC) who have not yet had surgery. The study aims to see if this treatment can improve outcomes before surgery and help prevent cancer from returning.

Patient Parameters

Program Overview

This study is exploring the use of pembrolizumab, a medication that helps the immune system fight cancer, in patients with high-risk cutaneous squamous cell carcinoma (cSCC) who have not yet had surgery. The goal is to see if this treatment can help control the cancer and improve the chances of staying cancer-free after surgery. The study will last for 52 weeks and will include patients who have not previously received PD-1 inhibitor treatments.

Description

Participants in this study will be patients with high-risk cutaneous squamous cell carcinoma (cSCC) who have not yet had surgery to remove the cancer. The study excludes those who have previously been treated with PD-1 inhibitors like nivolumab or pembrolizumab. Eligible patients will undergo a screening process that includes scans, biopsies, and blood tests to confirm their suitability for the study.

Once enrolled, participants will receive pembrolizumab for 6 weeks before surgery. After surgery, they will continue to receive pembrolizumab for an additional 45 weeks. If needed, radiation therapy may be given alongside pembrolizumab after surgery. The total treatment duration with pembrolizumab is one year.

The study aims to evaluate how well pembrolizumab works in shrinking the cancer before surgery and in preventing the cancer from returning after surgery. Participants will be closely monitored throughout the study to assess the treatment's effectiveness and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of high-risk localized or regional cutaneous squamous cell carcinoma (cSCC).
  • Cancer must be considered resectable (able to be surgically removed) and meet specific size and risk criteria.
  • Men must agree to use contraception during treatment and for 120 days after the last dose.
  • Women must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.
  • Participants must provide written informed consent.
  • Must have at least one measurable site of cancer.
  • Willing to undergo pre-treatment biopsies.
  • Have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have an immune system deficiency or are taking medications that suppress the immune system.
  • Have previously received PD-1 or similar immune therapies.
  • Have had recent chemotherapy or radiation therapy and not fully recovered from side effects.
  • Are currently participating in another clinical trial or have used an investigational device recently.
  • Women who are pregnant or breastfeeding.
  • Have received a live vaccine recently.
  • Have active autoimmune diseases requiring treatment.
  • Have other active cancers or untreated brain metastases.
  • Have severe allergies to pembrolizumab or its components.
  • Have active infections or a history of certain viral infections like HIV or hepatitis.
  • Have a history of tuberculosis or other conditions that could interfere with the study.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Have had an organ transplant.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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