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Checkpoint Inhibitor

Cabozantinib + Atezolizumab for Adrenocortical Cancer

Phase 2

Waitlist Available

Led By Bassel Nazha, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Histologically documented adrenal cortical carcinoma

Tumor tissue samples must be available for submission prior to initiation of study treatment. If not, agree to undergo biopsy

Must not have

Concomitant mitotane use

Current treatment with anti-viral therapy for hepatitis B virus (HBV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a combo of drugs can help treat advanced adrenal cortical cancer. The drugs may inhibit tumor growth/blood vessel formation and help body's immune system attack.

Who is the study for?

Adults with advanced or inoperable adrenal cortical cancer, who may have had previous treatments. They must be physically able to perform daily activities (ECOG <=2), expect to live at least 12 weeks, and not have certain viral infections. Women of childbearing age need a negative pregnancy test and agree to use effective contraception.

What is being tested?

The trial is testing the combination of Cabozantinib, which blocks tumor growth signals, with Atezolizumab, an immunotherapy that helps the immune system fight cancer. The study aims to see if this combo is better than using each drug alone for treating adrenal cortical cancer.

What are the potential side effects?

Possible side effects include fatigue, high blood pressure, hand-foot syndrome (redness and pain in hands/feet), diarrhea, decreased appetite, nausea; Atezolizumab can cause immune-related issues like inflammation in organs such as lungs or intestines.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed to be adrenal cortical carcinoma.

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I can provide tumor samples or agree to a biopsy before starting the study.

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I have either not been treated or have received multiple treatments.

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My cancer has spread or cannot be removed by surgery.

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I am a woman who can have children and have a negative pregnancy test.

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I am 18 years old or older.

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

Exclusion Criteria

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

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I am currently taking mitotane.

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I am currently on medication for hepatitis B.

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I have had cancer spread to the lining of my brain and spinal cord.

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I am currently taking blood thinners.

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I do not have any major health issues like heart problems, severe pain, or uncontrolled bleeding.

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I do not have an active infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks, assessed up to 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

Overall response rate (ORR)

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

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 (cabozantinib, Atezolizumab)Experimental Treatment5 Interventions

Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle 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 computed tomography (CT) and/or magnetic resonance imaging (MRI) at screening and then every 12 weeks on study and undergo collection of blood samples at screening, on study, and at end of treatment. Patients without archival tissue also undergo biopsy at screening.

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