Study on Cosibelimab for Skin Cancer in Patients with Kidney Transplants or Blood Cancers

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07426484

Provider View

This clinical trial is testing the safety and effectiveness of the drug cosibelimab in patients with advanced skin cancer who have either had a kidney transplant or have certain blood cancers.

Patient Parameters

Program Overview

This study aims to evaluate how safe and effective cosibelimab is for treating advanced cutaneous squamous cell carcinoma (CSCC) in special groups of patients. These groups include those who have had a kidney transplant or have specific blood cancers. Cosibelimab is a type of medication known as an anti-PD-L1 antibody, which helps the immune system fight cancer cells.

Description

This is a Phase IV clinical trial conducted at multiple locations to test cosibelimab in patients with advanced skin cancer. The study is supported by Checkpoint Therapeutics, which provides the study drug. Participants will be divided into two groups: Group A for those with a history of kidney transplant, and Group B for those with certain blood cancers.

Cosibelimab is already approved by the FDA for treating advanced skin cancer. The study involves several procedures, including eligibility screening, clinic visits, blood and urine tests, scans, heart tests, and tumor biopsies. About 80 people are expected to participate in this study.

Eligibility Criteria

Inclusion Criteria

  • Group A: Must have had a kidney transplant at least 6 months ago.
  • Group B: Must have a blood cancer like chronic myeloproliferative neoplasm or indolent non-Hodgkin's lymphoma.
  • Must have a confirmed diagnosis of advanced skin cancer (CSCC) that cannot be treated with surgery or radiation.
  • Must have measurable disease as per specific criteria.
  • Must be 18 years or older.
  • Must have good overall health and organ function as determined by specific medical tests.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for 120 days after the last dose of cosibelimab.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent treatment with certain cancer drugs within the past 12 months.
  • Recent treatment with CAR-T cell therapies or certain chemotherapy regimens within the past 6 months.
  • Unresolved side effects from previous cancer treatments.
  • Active autoimmune disease requiring certain medications.
  • Severe lung disease or history of lung inflammation requiring steroids.
  • Current participation in another cancer study or use of investigational drugs.
  • Uncontrolled infections or need for systemic antibiotics.
  • Uncontrolled brain metastases requiring steroids.
  • Significant heart disease or need for dialysis.
  • History of stem cell or bone marrow transplant.
  • Psychiatric or social issues affecting study participation.
  • Pregnant or breastfeeding women.
  • Other cancers that could interfere with the study.
  • Group A: History of organ transplant other than kidney.
  • Group B: History of any solid organ transplant, except cornea transplant.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02115BostonMassachusetts
Dana-Farber Cancer Institute02115BostonMassachusetts

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