Study on Ipilimumab, Nivolumab, and Ciforadenant for First-line Treatment of Advanced Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05501054

Provider View

This clinical trial is testing a combination of three drugs—ipilimumab, nivolumab, and ciforadenant—to see if they can help control advanced kidney cancer in patients who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—ipilimumab, nivolumab, and ciforadenant—can safely and effectively treat advanced kidney cancer that has not been treated before. Researchers will look at how well the treatment works in shrinking tumors and how long patients can live without the cancer getting worse.

Description

This study is divided into two phases: Phase 1b and Phase 2.

In Phase 1b, the main goal is to determine if the combination of ipilimumab, nivolumab, and ciforadenant is safe and tolerable for patients with advanced kidney cancer. Researchers will monitor patients for any side effects and assess how well they tolerate the treatment.

In Phase 2, the study will evaluate how effective the treatment is in controlling the cancer. Researchers will measure the response rate, how long the response lasts, and how long patients can live without the cancer progressing. They will also explore any potential links between genetic markers and treatment outcomes.

Participants will undergo various tests and scans to monitor their health and the cancer's response to the treatment. The study aims to provide valuable insights into whether this combination of drugs can offer a new treatment option for patients with advanced kidney cancer.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate in the study.
  • Be 18 years or older.
  • Have a confirmed diagnosis of clear cell kidney cancer.
  • Have stage IV metastatic kidney cancer.
  • Have not received any prior systemic treatment for advanced kidney cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Provide a tumor tissue sample for analysis.
  • Be willing to undergo bone and brain scans at the start of the study and continue if needed.
  • Have adequate organ function as determined by specific blood tests.
  • Women must not be breastfeeding and must have a negative pregnancy test before starting treatment.
  • Women of childbearing potential must agree to use effective contraception during the study and for 23 weeks after the last dose.
  • Men must agree to use effective contraception during the study and for 31 weeks after the last dose if they are sexually active with women of childbearing potential.

Exclusion Criteria

  • Have received any prior systemic treatment for advanced kidney cancer within 6 months before starting the study.
  • Have had major surgery or a suspected COVID-19 infection within 28 days before starting the study.
  • Have had radiosurgery, radiotherapy, minor surgery, or an active infection requiring treatment within 14 days before starting the study.
  • Have active bleeding or difficulty swallowing medication.
  • Have cancer that has spread to the brain unless it is stable and not causing symptoms.
  • Require treatment with high-dose steroids or other immunosuppressive medications.
  • Have an active autoimmune disease, except for certain conditions like type I diabetes or hypothyroidism that only require hormone replacement.
  • Have a psychiatric or medical condition that could increase the risk of participating in the study or affect the ability to follow study procedures.

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