Genetic Testing to Choose Treatment for Advanced or Metastatic Kidney Cancer: OPTIC RCC Study

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05361720

Provider View

This study is exploring whether genetic testing of kidney cancer tumors can help doctors choose the best treatment for patients with advanced or metastatic kidney cancer. The study compares two treatment options: a combination of two immunotherapy drugs or one immunotherapy drug with a targeted therapy pill.

Patient Parameters

Program Overview

This phase II study is investigating if genetic testing of tumor tissue can help select the best treatment for patients with advanced or metastatic kidney cancer. The study compares two FDA-approved treatment options: one uses two immunotherapy drugs (nivolumab and ipilimumab) given through IV, and the other combines an immunotherapy drug (nivolumab) with a targeted therapy pill (cabozantinib). Immunotherapy helps the immune system fight cancer, while targeted therapy blocks cancer growth. The study aims to see if genetic testing can match the best treatment to the cancer, improving the chances of a positive response.

Description

The main goal of this study is to improve the response rate of initial treatment in advanced kidney cancer by using genetic testing to assign patients to one of two treatment groups based on their tumor's genetic profile.

In the first group, patients receive two immunotherapy drugs, ipilimumab and nivolumab, through IV every 21 days for four cycles. After that, they continue with nivolumab every four weeks if the cancer does not progress or cause severe side effects.

In the second group, patients receive nivolumab through IV and take cabozantinib as a daily pill. This cycle repeats every four weeks as long as the treatment is effective and tolerable.

After finishing the study treatment, patients will have a follow-up visit within 30 days of their last dose.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of kidney cancer with clear cell features.
  • Cancer is advanced or has spread and cannot be cured with surgery or radiation.
  • Able to understand and sign the consent form.
  • Aged 18 or older.
  • Good overall health with a performance status of 70% or higher.
  • No previous systemic treatment for kidney cancer.
  • At least one measurable tumor.
  • Tumor tissue available for genetic testing.
  • Good kidney and liver function based on specific blood tests.
  • Women of childbearing age must have a negative pregnancy test and use effective birth control.

Exclusion Criteria

  • Major surgery within 14 days before starting treatment.
  • Uncontrolled high blood pressure.
  • Active infection needing IV treatment.
  • Existing fistula or abnormal connection between organs.
  • High levels of protein in urine.
  • Non-healing wounds (for patients taking cabozantinib).
  • Significant bleeding issues.
  • Difficulty swallowing pills or severe digestive disorders (for patients taking cabozantinib).
  • Serious heart conditions or recent heart attack.
  • Brain metastases are allowed if treated and stable.
  • Need for high-dose steroids or immunosuppressive drugs within 14 days before treatment.

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