← Back to Search

Checkpoint Inhibitor

Cabozantinib + Atezolizumab for Adrenocortical Cancer

Q: Is this clinical research presently accepting participants?

<p>Clinicaltrials.gov attests that the trial is no longer actively recruiting patients, as was last evidenced on August 17th 2023 when it was updated for the final time since its inception on October 1st 2023. Nevertheless, there are currently 2566 other trials searching for volunteers.</p>

Q: What potential risks may patients encounter when taking cabozantinib and atezolizumab?

<p>Due to the nature of this Phase 2 trial, and the lack of evidence for efficacy but some data on safety, Treatment (cabozantinib, atezolizumab) was ranked a 2 by our team.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks, assessed up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My cancer is confirmed to be adrenal cortical carcinoma.

Select...

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

Select...

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

Select...

My cancer has spread or cannot be removed by surgery.

Select...

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

Select...

I am 18 years old or older.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Incidence of adverse events

Overall survival

Progression free survival

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

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1730

Cabozantinib S-malate

2013

Completed Phase 2

~470

Atezolizumab

2017

Completed Phase 3

~5860

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,552 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,646 Total Patients Enrolled

1 Trials studying Adrenal Cortex Carcinoma

109 Patients Enrolled for Adrenal Cortex Carcinoma

Bassel Nazha, MD, MPHPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

3 Previous Clinical Trials

79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research presently accepting participants?

"Clinicaltrials.gov attests that the trial is no longer actively recruiting patients, as was last evidenced on August 17th 2023 when it was updated for the final time since its inception on October 1st 2023. Nevertheless, there are currently 2566 other trials searching for volunteers."

Answered by AI

What potential risks may patients encounter when taking cabozantinib and atezolizumab?

"Due to the nature of this Phase 2 trial, and the lack of evidence for efficacy but some data on safety, Treatment (cabozantinib, atezolizumab) was ranked a 2 by our team."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cabozantinib in Combination With Atezolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer

Bassel Nazha 2024. "Cabozantinib in Combination With Atezolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006013.