Study on V940 and Pembrolizumab for Treating Advanced Skin Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06295809

Provider View

This clinical trial is testing a new treatment using V940 and pembrolizumab for patients with advanced cutaneous squamous cell carcinoma (cSCC) that can be surgically removed. The study aims to see if this combination, given before and after surgery, is more effective than the standard treatment alone.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with advanced cutaneous squamous cell carcinoma (cSCC) that can be surgically removed. The trial is divided into two parts. In the first part, researchers will test the safety and effectiveness of combining V940, an individualized therapy, with pembrolizumab, an immunotherapy drug, both before and after surgery. This will be compared to the standard treatment, which may include surgery and possibly radiation. If the results are promising, the study will expand to include more participants to further evaluate the treatment's effectiveness in improving event-free survival, which means the time patients remain free from cancer-related events.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with resectable cutaneous squamous cell carcinoma (cSCC) as the main cancer type.
  • Cancer is at stage II-IV without spreading to distant parts of the body.
  • Cancer can be surgically removed with the aim of curing it.
  • Able to provide a suitable tumor sample for genetic testing required for the study.
  • Men must agree to use effective birth control during and after treatment.
  • Women must not be pregnant or breastfeeding and must use effective birth control if they are of childbearing potential.
  • Have measurable cancer as determined by medical scans.
  • Expected to live for more than 3 months according to the doctor.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Have adequate organ function based on medical tests.
  • If positive for hepatitis B, must have undetectable viral load after treatment.
  • If previously infected with hepatitis C, must have undetectable viral load.
  • If HIV-positive, must have well-controlled HIV with medication.

Exclusion Criteria

  • Have any other type of skin cancer besides invasive cSCC.
  • Cancer has spread to distant parts of the body.
  • Have received certain types of cancer treatments before joining the study.
  • Have had recent radiation therapy or have side effects from it.
  • Have received a live vaccine recently.
  • Have had a blood transfusion or certain medications recently.
  • Have been treated with another cancer vaccine before.
  • Have had radiation to the main cancer area and not fully recovered.
  • Have used an investigational drug or device recently.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
  • Have another progressing cancer or one that needed treatment in the last 2 years.
  • Have a history of chronic lymphocytic leukemia (CLL).
  • Have cancer that has spread to the brain or spinal cord.
  • Have severe allergies to V940 or pembrolizumab.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung disease needing steroids.
  • Have an active infection needing treatment.
  • Have HIV with a history of certain related diseases.
  • Have active hepatitis B and C infections.
  • Have had a heart attack in the last 6 months.
  • Have had a tissue or organ transplant.
  • Have not fully recovered from major surgery.

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