Immunotherapy with Prednisone and Sirolimus for Kidney Transplant Patients with Advanced Skin Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05896839

Provider View

This study is testing a combination of immunotherapy drugs, nivolumab and ipilimumab, with sirolimus and prednisone to treat skin cancer that can't be removed or has spread in kidney transplant patients. The goal is to see if this treatment can kill cancer cells while keeping the transplanted kidney healthy.

Patient Parameters

Program Overview

This phase II trial is exploring a new treatment for kidney transplant patients who have skin cancer that cannot be surgically removed or has spread to other parts of the body. The treatment combines immunotherapy drugs, nivolumab and ipilimumab, with sirolimus and prednisone, which are used to prevent kidney rejection. The aim is to see if this combination can effectively target cancer cells while maintaining the health of the transplanted kidney.

Description

The main goal of this study is to see how well the combination of prednisone, sirolimus, nivolumab, and ipilimumab works in kidney transplant patients with advanced skin cancer. Researchers will check if patients have a complete or partial response to the treatment or if their disease remains stable without losing the transplanted kidney.

The study will also look at how long patients live without the cancer getting worse and their overall survival. Researchers will explore how the immune system responds to the treatment and if there are any changes in the cancer environment.

Patients will take sirolimus and prednisone by mouth daily, starting a week before the first immunotherapy session. They will receive nivolumab and ipilimumab through an IV on specific days. After six weeks, doctors will assess the cancer's response. If the cancer is stable or improving, patients will continue with nivolumab every four weeks for up to 24 cycles, unless the cancer progresses or side effects become too severe.

Patients may have MRI scans, tumor biopsies, CT scans, and blood tests throughout the study. If kidney rejection is suspected, a kidney biopsy may be performed. Follow-up visits will occur every 12 weeks for the first year after stopping treatment, then every 16 weeks for the second year, and every 20 weeks for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must be a kidney transplant recipient with a working kidney and not on dialysis.
  • Must be 18 years or older.
  • Must have certain types of skin cancer that can't be treated with standard therapies.
  • Must have measurable cancer that can be tracked.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential must use contraception during and after treatment.
  • Must not have active HIV, hepatitis B, or hepatitis C infections unless controlled.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have received a liver, lung, heart, or pancreas transplant.
  • Cannot have a history of organ rejection within the last three months.
  • Cannot have had certain cancer treatments within the last year.
  • Cannot have untreated brain metastases or require high-dose steroids for brain symptoms.
  • Cannot have severe allergies to study drugs.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot be pregnant or breastfeeding.
  • Cannot have active autoimmune diseases affecting vital organs.
  • Cannot have certain gastrointestinal or heart conditions without evaluation.

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