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Tyrosine Kinase Inhibitor

Cabozantinib for Melanoma

Phase 2

Waitlist Available

Led By Geoffrey T Gibney, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

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

Must have

Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

Adequate organ and marrow function.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a combination of three drugs to treat melanoma. The drugs will be given for 12 weeks, followed by maintenance therapy for up to 2 years. The goal is to see how well the combination works in preventing disease progression.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

The progression free survival (PFS) for nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

Secondary outcome measures

The incidence of treatment-emergent adverse events of nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

The overall survival (OS) of patients with unresectable advanced melanoma treated with nivolumab/ipilimumab plus cabozantinib.

The response rate of nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

Other outcome measures

Associations between baseline mutations in genes regulating anti-tumor immunity with tumor immunophenotype and clinical activity of nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

Associations between baseline tumor mutational burden (TMB), angiogenesis pathways, and immunophenotyping with clinical activity of nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

On treatment biopsy for evidence of increased immune infiltration, vascularization, and MHC expression to nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment3 Interventions

Induction phase: Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period) Cabozantinib 40mg PO daily for 12 weeks Maintenance phase: Nivolumab 480mg IV every 4 weeks for up to 92 weeks Cabozantinib 40mg PO daily for up to 92 weeks Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Cabozantinib

2020

Completed Phase 2

~1080

Nivolumab

2014

Completed Phase 3

~4750

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedStar Franklin Square Medical CenterOTHER

1 Previous Clinical Trials

100 Total Patients Enrolled

Hackensack Meridian HealthOTHER

131 Previous Clinical Trials

28,217 Total Patients Enrolled

1 Trials studying Melanoma

ExelixisIndustry Sponsor

117 Previous Clinical Trials

19,524 Total Patients Enrolled

5 Trials studying Melanoma

293 Patients Enrolled for Melanoma

Frequently Asked Questions

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

Are there any available positions for patients in this trial?

"Yes, this experiment is still ongoing and looking for volunteers. The trial was announced on March 2nd, 2020 and has had two updates since then; the most recent being on May 3rd, 2022."

Answered by AI

How many people have been asked to participate in this clinical trial?

"Yes, this clinical trial is still recruiting patients. Per the information available on clinicaltrials.gov, the original posting was on March 2nd, 2020. The most recent update was on May 3rd, 2022. They are currently looking for 27 individuals to participate at 3 different locations."

Answered by AI

What are the short-term and long-term effects of Cabozantinib?

"Because this is a Phase 2 trial, there is clinical evidence indicating that Cabozantinib is safe for human use. However, its efficacy has not yet been studied."

Answered by AI

What medical conditions does Cabozantinib help to treat?

"Cabozantinib is most often used to treat melanoma that cannot be surgically removed. However, it can also help patients with squamous cell carcinoma and a high risk of disease recurrence."

Answered by AI

Are there other ongoing or completed research projects that have looked at Cabozantinib?

"The first clinical trial studying the effects of cabozantinib was completed in 2009 at Texas Children's Hospital. Since then, there have been a total of 415 clinical trials evaluating this medication. As of now, 879 different clinical trials are ongoing with numerous sites based in Hackensack, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

2020. "Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04091750.