Study on Maintenance Therapy with Pembrolizumab After Radiation for Oligometastatic Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06004336

Provider View

This clinical trial is exploring whether adding a year of treatment with pembrolizumab can help control kidney cancer after radiation therapy. The study compares the effects of pembrolizumab with just observation after radiation.

Patient Parameters

Program Overview

The purpose of this study is to find out if continuing treatment with pembrolizumab for one year after radiation therapy can help keep kidney cancer under control. The study will compare patients who receive pembrolizumab with those who are only observed after radiation to see which approach is more effective in preventing cancer from coming back or spreading.

Description

This study aims to determine if pembrolizumab, given after radiation therapy, can improve outcomes for patients with kidney cancer that has spread to a few other areas (oligometastatic). The main goal is to see if this approach can help patients live longer without the cancer getting worse.

Secondary goals include:

  • Checking overall survival rates between the two groups.
  • Measuring the time until patients need another type of treatment.
  • Evaluating how long patients remain free from cancer returning locally or spreading to distant areas.
  • Monitoring any side effects from the treatment.

The study will also explore how certain biological markers in the blood and tissue relate to patient outcomes and how they change after radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a confirmed diagnosis of kidney cancer with a clear cell component.
  • Be willing to undergo a biopsy of a tumor planned for radiation, unless medically unfit or at risk.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have measurable disease based on specific criteria.
  • Have no more than 5 metastatic lesions at the time of study entry.
  • Have adequate organ function as shown by specific blood tests.
  • Have at least one tumor site that can be treated with radiation and biopsied.
  • Meet specific criteria for hepatitis B and C if applicable.
  • Have adequate blood cell counts and organ function as defined by laboratory tests.

Exclusion Criteria

  • Have received certain cancer treatments within specific time frames before starting the study.
  • Have conditions that weaken the immune system, such as HIV or a history of organ transplant.
  • Have used immunosuppressive medication recently, except for certain types of steroids.
  • Have psychiatric or substance abuse disorders that interfere with study participation.
  • Have had severe side effects from previous immune therapy, except for hormone-related issues.
  • Have received a live vaccine recently.
  • Have cognitive impairments that prevent understanding the study.
  • Have widespread cancer that cannot be treated definitively.
  • Be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have a positive pregnancy test before starting the study.

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