Study Comparing Two Drug Combinations for First-line Treatment of Advanced Kidney Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06708949
This clinical trial is testing two different combinations of drugs to see which is more effective for treating advanced kidney cancer in patients who have not received prior treatment. The study involves comparing a three-drug combination with a two-drug combination.
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness of two different drug combinations in treating advanced kidney cancer. One group will receive a combination of three drugs: nivolumab, relatlimab, and ipilimumab. The other group will receive two drugs: nivolumab and ipilimumab. The study aims to determine which combination is safer and more effective in shrinking tumors in patients who have not been treated for their advanced kidney cancer before.
Description
This study is designed to evaluate the safety and effectiveness of two different drug combinations for treating advanced kidney cancer. The first combination includes nivolumab, relatlimab, and ipilimumab, while the second combination includes nivolumab and ipilimumab. The study will involve patients who have not received any prior treatment for their advanced kidney cancer.
Participants will be randomly assigned to one of the two treatment groups. The study will monitor the safety of the treatments and how well they work in reducing the size of the tumors. The main goal is to find out which combination is more effective and has fewer side effects.
The study will also look at the overall response rate, which measures how many patients experience a significant reduction in tumor size. Participants will receive the treatments through intravenous (IV) infusions at specified intervals and will be closely monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
- Must be willing and able to provide written consent to participate.
- Must be 18 years or older.
- Must have a confirmed diagnosis of kidney cancer with a clear cell component.
- Must have stage IV metastatic kidney cancer.
- Must not have received any prior systemic therapy for kidney cancer.
- Must have a performance status score of 70% or higher, indicating the ability to carry out normal activities.
- Must have at least one measurable tumor that can be tracked using standard criteria.
- Must have adequate organ function as shown by specific blood tests.
- Women must not be breastfeeding during the study and for five months after the last dose.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 23 weeks after the last dose.
Exclusion Criteria
- Cannot have received any prior systemic treatment for kidney cancer.
- Cannot have had major surgery requiring general anesthesia within 28 days before starting treatment.
- Cannot have had radiation therapy or minor surgery within 14 days before starting treatment.
- Cannot have an active infection requiring treatment.
- Cannot have a history of or current cancer spread to the brain.
- Cannot be taking high doses of steroids or other immune-suppressing medications.
- Cannot have an active autoimmune disease, except for certain controlled conditions.
- Cannot have a psychiatric or medical condition that would interfere with study participation.
- Cannot have a history of heart inflammation.
- Cannot have high levels of certain heart enzymes unless cleared by a doctor.
- Cannot have received a live vaccine within 30 days before starting treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | 77030 | Houston | Texas |
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