Drug Combinations for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmado Zurita, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.

Eligibility Criteria

Adults with metastatic renal cell carcinoma (RCC) that includes a clear cell component, who have had surgery or certain other treatments for their primary tumor. They must be able to swallow pills, not have received targeted therapy or chemotherapy for mRCC (though prior immunotherapy is okay), and agree to use birth control. People with active infections, another cancer treatment ongoing, significant heart issues, uncontrolled hypertension or diabetes, severe liver disease, brain metastases (except controlled solitary ones), coagulation disorders on certain anticoagulants are excluded.

Inclusion Criteria

Patients must give written informed consent prior to initiation of study-related procedures. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy

I can swallow pills.

I am 18 years old or older.

+8 more

Exclusion Criteria

Your diabetes is not well managed, as shown by high fasting blood sugar levels.

I am not allergic to bevacizumab, pazopanib, or everolimus.

I am not planning to take any experimental drugs but can take bisphosphonates while in this study.

+22 more

Participant Groups

The START trial is testing six different combinations of the drugs everolimus, bevacizumab, and pazopanib in sequences to see which works best against metastatic kidney cancer. Participants will start with one drug and may switch to another as part of the sequence while researchers monitor safety and effectiveness.

6Treatment groups

Experimental Treatment

Group I: Group 6Experimental Treatment2 Interventions

Bevacizumab + possible Everolimus

Group II: Group 5Experimental Treatment1 Intervention

Bevacizumab + possible Pazopanib

Group III: Group 4Experimental Treatment2 Interventions

Everolimus + possible Pazopanib

Group IV: Group 3Experimental Treatment2 Interventions

Everolimus + possible Bevacizumab

Group V: Group 2Experimental Treatment2 Interventions

Pazopanib + possible Everolimus