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Acarbose for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of clear cell or non-clear cell carcinoma of the kidney, except for medullary carcinoma, collecting duct carcinoma, lymphoma and sarcoma. Sarcomatoid features of any degree are allowed

Demonstrates adequate organ function defined as follows: Liver function (bilirubin < 3mg/dL, AST and/or ALT <3 x ULN), Kidney function (CrCL >=15ml/min using cockroft-gault method), ANC >= 500/microliter, Hemoglobin > 8 mg/dL, platelet count > 50,000/microliter

Must not have

Has received a live virus vaccine within 30 days of randomization

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat kidney cancer. They want to see if it's safe and how well it works.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include digestive issues like gas and bloating since acarbose works in the gut to slow carbohydrate breakdown. There may also be risks associated with combining it with immunotherapy such as fatigue, skin reactions, or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer is not one of the excluded types.

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

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My kidney cancer is advanced and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently being treated for an infection.

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

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I have untreated brain metastases or carcinomatous meningitis.

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

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

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the effect of acarbose on the gut microbiome in patients receiving as standard of care therapy.

To assess the safety profile of acarbose in addition to standard of care (SOC) treatment in RCC

Secondary study objectives

To assess the efficacy of Acarbose in combination with SOC treatment in RCC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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) \[Refractory pts\]

0 / 14Eligibility criteria met