Acarbose for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients.

Eligibility Criteria

This trial is for adults with advanced kidney cancer who haven't had systemic therapy in the last 3 weeks. They must have a certain level of physical ability, agree to use contraception, and have specific organ function levels. Excluded are those with treated diabetes, psychiatric issues affecting study cooperation, recent major surgery or other treatments, severe allergies to acarbose or standard care drugs.

Inclusion Criteria

My kidney cancer is not one of the excluded types.

My liver, kidneys, and blood counts are within the required ranges.

My kidney cancer is advanced and cannot be surgically removed.

Exclusion Criteria

I have not received a live virus vaccine in the last 30 days.

I am currently being treated for an infection.

My diabetes is managed with medication and my HbA1c is below 8.

I have untreated brain metastases or carcinomatous meningitis.

My blood pressure is high despite taking 3 or more medications for it.

I have had low blood sugar episodes in the past year.

I am not using, nor do I plan to use, certain medications like carbamazepine or St. John's wort.

I have not had active GI bleeding or unresolved issues in the last 3 months.

I have another cancer that has worsened or needed treatment in the past 3 years.

I am currently using or might need strong CYP3A4/5 inhibitors.

I have a GI condition that affects how my body absorbs pills.

Participant Groups

The trial tests the safety and effectiveness of acarbose tablets when added to standard immunotherapy in treating advanced renal cell carcinoma. Participants will receive this combination treatment and be monitored for how well they tolerate it and any signs of improvement.

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Ipilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID) OR Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Frontline/Refractory pts\] OR Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Refractory pts\] OR Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[Refractory pts\]