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Monoclonal Antibodies

Triple Drug Therapy for Kidney Cancer

Phase 2

Recruiting

Led By Ramaprasad Srinivasan

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

Subjects must provide archival tissue block or unstained tumor tissue or be willing to undergo biopsy to collect samples for retrospective central pathology review

Patients must have received no more than two prior regimens targeting the VEGF pathway and no prior bevacizumab therapy in the metastatic/advanced setting

Must not have

Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1

Major surgical procedure < 28 days before cycle 1, day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from study enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of 3 drugs to treat patients with advanced hereditary leiomyomatosis and kidney cancer.

Who is the study for?

This trial is for individuals aged 12 or older with advanced kidney cancer, including hereditary leiomyomatosis and renal cell carcinoma. Participants must have measurable disease, acceptable organ function, no more than two prior VEGF-targeted treatments, and no recent use of certain medications or therapies. Those with treated brain metastases stable for at least 3 months can join. Pregnant women and tobacco users who cannot quit are excluded.

What is being tested?

The study tests a combination therapy using bevacizumab (stops blood vessels from feeding tumors), erlotinib (blocks proteins that signal cancer cells to multiply), and atezolizumab (boosts the immune system to fight cancer). The goal is to see if this trio can stabilize or shrink advanced-stage kidney cancers.

What are the potential side effects?

Potential side effects include high blood pressure, bleeding problems from bevacizumab; rash and diarrhea from erlotinib; fatigue, coughing up blood, shortness of breath due to lung inflammation from atezolizumab. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I can provide a tissue sample from my tumor or am willing to have a biopsy.

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I have had 2 or fewer treatments targeting VEGF but no bevacizumab for my advanced cancer.

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I have been diagnosed with HLRCC or papillary renal cell carcinoma.

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I can take care of myself but might not be able to do heavy physical work.

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I am 12 years old or older.

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My hepatitis B is under control with treatment.

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My kidney function, measured by GFR, is adequate.

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I had hepatitis C but have been treated and cured.

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I have advanced kidney cancer with at least one tumor that can be measured.

Exclusion Criteria

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

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have not had major surgery in the last 28 days.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.

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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.

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I am not pregnant or breastfeeding.

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I am not taking strong drugs that affect liver enzyme CYP450 3A4 or 1A2, or I can stop them before starting the study treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from study enrollment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Incidence of adverse events

+4 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

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: Treatment (bevacizumab, atezolizumab, erlotinib)Experimental Treatment11 Interventions

Patients receive bevacizumab IV over 30-90 minutes and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Patients also receive erlotinib 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 with or without contrast and MRI throughout the trial. Patients undergo collection of blood throughout the trial, and may undergo a biopsy during screening, as well as a brain MRI/CT scan with contrast, bone scan, and/or F-18 sodium fluoride PET scan as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Bone Scan

2015

Completed Phase 2

~50