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Checkpoint Inhibitor

Cabozantinib +/− Atezolizumab for Advanced Kidney Cancer

Phase 2

Recruiting

Led By Benjamin L Maughan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS

Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling

Must not have

Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers

Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether cabozantinib with or without atezolizumab can shrink tumors in patients with metastatic papillary kidney cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, while atezolizumab may help the body's immune system attack the cancer.

Who is the study for?

Adults with advanced papillary kidney cancer that has spread, who have not had certain treatments like PD-1/PD-L1 inhibitors in the past 6 months. They must be able to swallow pills, have no major health issues affecting trial participation, and agree to use effective contraception if of reproductive potential.

What is being tested?

The PAPMET2 trial is comparing cabozantinib alone versus combining it with atezolizumab in patients with metastatic papillary renal cell carcinoma. The goal is to see if adding the immunotherapy agent improves outcomes compared to just the kinase inhibitor.

What are the potential side effects?

Potential side effects include high blood pressure, fatigue, diarrhea, liver enzyme changes, mouth sores, hand-foot syndrome (redness and pain on palms or soles), and possibly increased risk of infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured and is not in my brain or spinal cord.

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I don't need immediate treatment for brain metastases and don't have leptomeningeal disease.

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My blood pressure was below 150/100 mm Hg in the last two weeks.

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I have been diagnosed with a type of kidney cancer known as metastatic papillary renal cell carcinoma.

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I am 18 years old or older.

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I have never had bleeding in my brain or spinal cord.

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I have HIV, am on effective treatment, and my viral load is undetectable.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My recent tests show my urine protein is under control.

Exclusion Criteria

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

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I am not taking, nor will I take, strong medications that affect liver enzymes while on this treatment.

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I am not taking warfarin at doses meant to treat conditions. I may be on low dose aspirin or LMWH.

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I haven't had major surgery in the last 28 days and have recovered from any surgery effects.

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I am not taking, nor plan to take, strong CYP3A4 inducers.

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I haven't coughed up a noticeable amount of blood in the last 3 months.

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I am not on steroids for a brain condition.

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I haven't had PD-1/PD-L1 inhibitors in the last 6 months.

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My cancer has not spread to or around any major blood vessels.

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My cancer has not spread to my digestive system or airways in the last 28 days.

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I haven't had specific brain treatments in the last month before starting the study.

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I have never been treated with cabozantinib.

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I do not have holes in my lung tissue.

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I do not have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Progression free survival

Secondary study objectives

Incidence of adverse events

Objective response rate

Overall survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (cabozantinib S-malate, atezolizumab)Experimental Treatment6 Interventions

Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.

Group II: Arm I (cabozantinib S-malate)Active Control5 Interventions

Patients receive cabozantinib S-malate PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Atezolizumab

2016

Completed Phase 3

~5860