Study on XL092 with Immunotherapy for Patients with Clear Cell Kidney Cancer After Previous Treatment
Sponsor: Karie Runcie
ClinicalTrials ID:NCT06863311
This clinical trial is testing a new treatment using the drug XL092, alone or with the immunotherapy drug nivolumab, for patients with clear cell kidney cancer that has progressed after standard therapy. The study aims to determine if these treatments can help control the cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This Phase 2 study is for adults with clear cell kidney cancer that has worsened after receiving standard immunotherapy. Participants will be randomly assigned to one of two groups: one group will receive the drug XL092 alone, and the other group will receive XL092 combined with the immunotherapy drug nivolumab. The treatments will be given in 28-day cycles, and participants will continue treatment until the cancer progresses, side effects become too severe, or other reasons arise.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced or metastatic clear cell kidney cancer.
- Cancer must have worsened after receiving standard immunotherapy (anti-PD-1/PD-L1) and no other systemic therapy.
- Must have measurable disease based on specific medical criteria.
- Must have completed previous cancer treatment at least 2 weeks before starting the study and recovered from any side effects.
- Must have adequate organ function as shown by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Men must agree to use effective contraception if sexually active with a woman of childbearing potential.
- Patients with controlled HIV, hepatitis B, or hepatitis C infections may be eligible.
- Must be able to understand and agree to follow study procedures.
Exclusion Criteria
- Recent radiation therapy or ongoing complications from previous radiation.
- Known brain metastases unless treated and stable.
- Use of certain complementary medicines within 2 weeks before starting the study.
- Active infection requiring treatment.
- Positive TB test with active infection.
- Pregnant or breastfeeding women.
- Severe allergic reactions to study drugs.
- Other cancers that could interfere with the study.
- Recent live vaccine.
- Certain lung diseases or history of lung inflammation.
- Prior organ transplant.
- Inability to swallow pills.
- Uncontrolled major health issues.
- Recent blood clots or heart issues.
- Certain gastrointestinal disorders.
- Significant bleeding history.
- Other serious health conditions that could affect participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Columbia University Irving Medical Center | 10032 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
