Study on Combination Treatment with 177Lu Girentuximab, Cabozantinib, and Nivolumab for Patients with Advanced Clear Cell Kidney Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05663710
This clinical trial is exploring whether a combination of the drugs 177Lu girentuximab, cabozantinib, and nivolumab can help control advanced clear cell kidney cancer in patients who have not received prior treatment.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining the drugs 177Lu girentuximab, cabozantinib, and nivolumab can effectively manage advanced clear cell renal cell carcinoma (ccRCC) in patients who have not been treated before. The study will assess the safety of this combination and how well it works in shrinking tumors.
Description
The study aims to determine if the combination of 177Lu girentuximab, cabozantinib, and nivolumab is safe and effective for patients with advanced clear cell kidney cancer who have not received any previous treatment. Researchers will look at how many patients experience complete tumor shrinkage and how long the treatment can keep the cancer from progressing. The study will also evaluate the overall response rate and progression-free survival of patients receiving this combination therapy.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form before any study procedures.
- Must be 18 years or older.
- Must have advanced or metastatic kidney cancer with clear cell type.
- Must have at least one tumor that can be measured by scans.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must have adequate organ function, including specific blood counts and kidney and liver function.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must agree to use effective birth control during the study and for 120 days after the last dose.
- Must be able to swallow pills.
- Must provide a tumor tissue sample.
- Patients with brain metastases can participate if the brain tumors are stable and not life-threatening.
Exclusion Criteria
- Have received any prior treatment for metastatic kidney cancer.
- Have a history of certain brain or spinal cord conditions.
- Have an autoimmune disease requiring treatment.
- Have uncontrolled high blood pressure.
- Have had major heart problems in the last 6 months.
- Have any other serious medical or psychiatric conditions that could interfere with the study.
- Have an active infection needing treatment.
- Are participating in another clinical trial.
- Are taking certain medications that affect the liver.
- Have digestive issues that could affect medication absorption.
- Have tumors affecting major blood vessels.
- Have had major surgery recently without full recovery.
- Have another active cancer, except for certain skin cancers or cervical cancer in situ.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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