Study on Using a Recombinant Virus with Cemiplimab for Treating Kidney Cancer

Sponsor: SillaJen, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03294083

Provider View

This clinical trial is testing a new treatment that combines a recombinant virus, Pexa-Vec, with the drug Cemiplimab to see if it is safe and effective for patients with kidney cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

This study is exploring a new treatment for kidney cancer that has spread or cannot be surgically removed. The treatment combines a virus-based therapy called Pexa-Vec with Cemiplimab, a drug that helps the immune system fight cancer. The trial will first determine the safest dose of Pexa-Vec when used with Cemiplimab. Then, it will test the effectiveness of Cemiplimab alone or with Pexa-Vec, which can be given through a vein or directly into the tumor.

Eligibility Criteria

Inclusion Criteria

  • Have kidney cancer that has spread or cannot be removed by surgery.
  • For certain parts of the study, must have cancer that did not respond to previous treatments targeting PD-1 or PD-L1 proteins.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be 20 years or older.
  • Have good overall health and organ function as determined by specific tests.

Exclusion Criteria

  • Have a significant immune system deficiency or are taking medications that suppress the immune system.
  • Have had major surgery within the last 4 weeks.
  • Have severe skin conditions or a history of eczema that required treatment.
  • Have tumors affecting major blood vessels or important body structures.
  • Have significant heart disease or fluid buildup around the heart or lungs.
  • Cannot stop taking certain medications before and after receiving Pexa-Vec.
  • Have active Hepatitis B or C infections.

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