Comparing Immunotherapy-Based Drug Combination Therapy With or Without Kidney Surgery in Metastatic Kidney Cancer: The PROBE Trial

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04510597

Provider View

This study is exploring whether adding kidney surgery to a standard immunotherapy drug combination is more effective than using the drug combination alone for treating kidney cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This phase III trial is investigating if combining surgery to remove the kidney with a standard immunotherapy drug combination is more effective than the drug combination alone in treating metastatic kidney cancer. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab help the immune system fight cancer, while axitinib blocks enzymes that help cancer cells grow. Surgery to remove the kidney, known as nephrectomy, is a common treatment, but its benefits are debated. This study aims to find out if adding surgery improves treatment outcomes.

Description

Primary Objective:

  • To compare the overall survival of patients with newly diagnosed metastatic kidney cancer who receive a combination of immune checkpoint inhibitors and kidney surgery versus those who receive the drug combination alone.

Secondary Objectives:

  • To compare survival rates in patients who complete their assigned treatment.
  • To assess complications from kidney surgery and side effects from the drugs.
  • To compare how well the cancer responds in other parts of the body between the two groups.
  • To measure changes in the size of the primary tumor after 12 weeks of treatment.

Banking Objective:

  • To collect and store samples for future research.

Study Outline:

Pre-Randomization Treatment:

Patients who have not received prior treatment are assigned to one of three standard treatment regimens:

  • Regimen I: Nivolumab and ipilimumab given intravenously every 3 weeks for up to 4 cycles, followed by nivolumab every 2-4 weeks.
  • Regimen II: Pembrolizumab given intravenously on day 1 and axitinib taken orally twice daily for 21 days, repeated every 3 weeks.
  • Regimen III: Avelumab given intravenously on day 1 and axitinib taken orally twice daily for 14 days, repeated every 2 weeks.

Randomization Treatment:

After 10-14 weeks of pre-randomization treatment, patients are randomly assigned to one of two groups:

  • Arm I: Continue receiving nivolumab, pembrolizumab, or avelumab with axitinib.
  • Arm II: Undergo kidney surgery (nephrectomy) in addition to the same drug treatment as Arm I.

After completing the trial treatment, patients will have follow-up visits every 3 months for the first year, every 6 months for the next two years, and then annually for up to 7 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of kidney cancer, either clear cell or non-clear cell type.
  • Must have the primary kidney tumor still in place.
  • Must have scans showing the cancer has spread, completed within 90 days before joining the study.
  • Must not have any clear reasons that would prevent kidney surgery.
  • Must agree to provide samples for future research.
  • Must understand the study and sign a consent form.
  • Must have a follow-up scan 12 weeks after starting treatment to assess the cancer's response.
  • Must plan to continue the same immune-based therapy during the study.
  • Must be scheduled for surgery within 42 days of randomization.
  • Must have a physical exam and medical history review within 28 days before randomization.
  • Must have normal liver and kidney function based on specific blood tests.

Exclusion Criteria

  • Must not have active brain metastases. Previously treated brain metastases are allowed if there are no symptoms.
  • Must not have received prior treatment for metastatic kidney cancer beyond the study's specified treatment.
  • Must not have received more than the allowed amount of pre-randomization treatment.
  • Must not have received immunotherapy for any cancer within the past year.
  • Must not have a single kidney or a transplanted kidney.
  • Must not have other cancers, except for certain types that have been treated and are in remission.
  • Must not have medical conditions that make them ineligible for the study's treatments.

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