Sitravatinib + Nivolumab for Advanced Kidney Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Pavlos Msaouel | MD Anderson Cancer Center

Overseen byPavlos Msaouel

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?

This phase II trial investigates the effect of sitravatinib and nivolumab in treating patients with clear cell renal cell cancer that has spread to other places in the body (metastatic/advanced). Sitravatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sitravatinib and nivolumab may kill more tumor cells.

Eligibility Criteria

This trial is for adults with advanced or metastatic clear cell renal cell cancer who've had 1-2 previous treatments including specific therapies like PD-1/PD-L1 CPI. They must have measurable disease, be in good physical condition, and not pregnant. Exclusions include other recent cancers, certain medical conditions, and those on conflicting medications.

Inclusion Criteria

Your hemoglobin level is at least 9 grams per deciliter.

Your total bilirubin level should be less than or equal to 1.5 mg/dL.

My kidney function is normal and I don't need dialysis.

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Exclusion Criteria

Patients who cannot be compliant with the appointments required in this protocol

I have or had an autoimmune disease.

I have not had major surgery or significant injury within the last 28 days.

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Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Sitravatinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe trial tests sitravatinib combined with nivolumab against advanced kidney cancer. Sitravatinib may halt tumor growth by blocking enzymes needed for cell growth while nivolumab boosts the immune system to fight cancer cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (sitravatinib, nivolumab)Experimental Treatment4 Interventions

Patients receive sitravatinib PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: