Study on Cemiplimab or Cemiplimab and Fianlimab After Radiation Therapy for Clear Cell Kidney Cancer

Sponsor: University of Oklahoma

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07223541

Provider View

This clinical trial is testing the safety and effects of the drug cemiplimab, alone or with another drug called fianlimab, in patients with a type of kidney cancer called clear cell renal cell carcinoma. The study focuses on patients who have received radiation therapy for cancer that has spread to a few other areas.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of using cemiplimab, a PD-1 inhibitor, with or without fianlimab, a LAG-3 inhibitor, in patients with clear cell renal cell carcinoma that has spread to a few other areas (oligometastatic) after they have completed radiation therapy. The study will look at both the positive and negative effects of these treatments.

Description

All eligible patients will first receive standard radiation therapy to the main tumor and any cancer that has spread before being randomly assigned to one of two groups:

  • Group A: Patients will receive cemiplimab and fianlimab through an IV every three weeks for one year.
  • Group B: Patients will receive cemiplimab alone through an IV every three weeks for one year.

The treatment will continue for up to 17 cycles (about 12 months) or until the cancer returns, side effects become too severe, or other health issues prevent further treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
  • Must have between 1 and 5 cancer spots that can be measured by scans.
  • Can have small, untreated brain tumors with minimal symptoms or treated brain tumors that are stable.
  • Must have confirmation from a radiation doctor that all cancer sites can be treated with radiation.
  • Can have other cancers if they don't interfere with this study.
  • Must have a heart health assessment if there's a history of heart issues.
  • Women of childbearing age must have a negative pregnancy test before starting.
  • Must be able to understand and sign a consent form.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must have adequate organ and bone marrow function.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Patients with controlled hepatitis B or C are eligible.
  • Patients with previous radiation or surgery for cancer can participate if the cancer hasn't progressed.

Exclusion Criteria

  • Have untreated brain tumors larger than 2 cm or significant neurological issues.
  • Have a different type of kidney cancer.
  • Have cancer that has spread to the digestive tract.
  • Have more than 2 liver tumors or liver tumors causing jaundice.
  • Have received certain cancer treatments in the past year.
  • Have active autoimmune diseases requiring treatment.
  • Have had more than one prior treatment for metastatic cancer.
  • Have active tuberculosis.
  • Have uncontrolled high blood pressure.
  • Have had major surgery or serious wounds recently.
  • Have had recent heart attacks or strokes.
  • Have severe liver problems.
  • Have untreated blood clots.
  • Have unstable heart rhythms.
  • Have certain digestive issues or inflammatory bowel disease.
  • Are pregnant or breastfeeding.
  • Are not using effective birth control.
  • Have a history of heart inflammation.
  • Have high levels of certain heart markers.
  • Have recent serious infections.
  • Have uncontrolled infections or immune deficiencies.
  • Have allergies to study drugs.
  • Have received a live vaccine recently.
  • Women of childbearing potential must have a negative pregnancy test before starting.

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