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Tyrosine Kinase Inhibitor

Treatment (nivolumab and cabozantinib) for Hypopharyngeal Cancer

Phase 2

Recruiting

Led By Siwen Hu-Lieskovan

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 must not have evidence of preexisting uncontrolled hypertension

Participants must have an adequate archival tissue specimen or be willing to undergo research biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trialstudies combining two drugs to treat melanoma and head/neck cancer that has spread to other parts of the body. It also looks at biomarkers in tumors to see how well treatment works.

Who is the study for?

Adults with advanced melanoma or squamous cell head and neck cancer that has spread, who have progressed after PD-1 checkpoint therapy. They must be able to take oral medication, have measurable disease, known HPV/p16 status for oropharyngeal cancer, adequate organ function and performance status. Exclusions include prior anti-VEGF therapies, active autoimmune diseases requiring steroids, significant infections or organ dysfunction.Check my eligibility

What is being tested?

The trial is testing the combination of Cabozantinib (an enzyme blocker) and Nivolumab (an immunotherapy antibody) on patients with certain types of advanced cancers. It aims to see if these drugs can shrink or stabilize tumors based on biomarkers like 'tumor mutational burden' and 'tumor inflammation signature'.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs, fatigue, digestive issues due to Cabozantinib's enzyme-blocking action; Nivolumab might cause infusion reactions and increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I do not have high blood pressure that is uncontrolled.

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I can provide tissue samples or am willing to have a biopsy for research.

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I have never been treated with anti-VEGF therapies.

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I am not at high risk for bleeding due to my treatment.

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My melanoma is advanced (stage III or IV), cannot be surgically removed, or has spread.

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My cancer is a type of head and neck cancer that cannot be cured with surgery or has spread.

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I do not need blood thinners.

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I do not have any other cancer that could affect this treatment's safety or results.

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My cancer can be measured by tests or scans.

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My cancer progressed within 3 months after my last PD-1 inhibitor treatment.

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I do not have a condition that prevents me from absorbing nutrients properly.

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I can take pills as required.

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I have not received an organ transplant from another person.

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I can carry out all my normal activities without help.

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My chronic HBV infection is under control with an undetectable viral load.

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I am 18 years old or older.

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I have had only one radiotherapy for head/neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Biomarker results turnaround time

Objective response rate

Secondary outcome measures

Disease control rate

Overall survival

Progression-free survival

+2 more

Other outcome measures

Additional markers of response or resistance

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab and cabozantinib)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and cabozantinib PO daily. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans and collection of blood samples throughout the trial. Patients undergo a tumor biopsy during screening and optionally during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib S-malate

2013

Completed Phase 2

~470

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1720

Nivolumab

2014

Completed Phase 3

~4750

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,722 Previous Clinical Trials

40,964,932 Total Patients Enrolled

Siwen Hu-LieskovanPrincipal InvestigatorSWOG Cancer Research Network

1 Previous Clinical Trials

42 Total Patients Enrolled

~15 spots leftby Sep 2024

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