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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 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
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Nivolumab
2014
Completed Phase 3
~4750
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,003 Total Patients Enrolled
Siwen Hu-LieskovanPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

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

To what ailments is the treatment of nivolumab and cabozantinib most commonly applied?

"Nivolumab and cabozantinib are treatments traditionally used for malignant neoplasms. But, they can be prescribed to patients with unresectable melanoma, squamous cell carcinoma, or metastatic esophageal adenocarcinoma if their symptoms warrant it."

Answered by AI

What evidence is there to suggest that the use of nivolumab and cabozantinib carries no risk for those receiving it?

"The safety of the nivolumab and cabozantinib combination therapy was deemed a 2 because, despite there being some evidence supporting its security profile, no data confirming efficacy has been presented."

Answered by AI

Is this study precedent-setting in its methodology?

"Treatment (nivolumab and cabozantinib) has been the subject of extensive clinical research since its initial trial in 2012, sponsored by Exelixis. Following a successful Phase 1 study involving 86 patients, it was progressed to Phase 2 approval. In total, 794 trials are currently underway across 53 nations and 2553 cities."

Answered by AI

What is the maximum capacity of participants for this experiment?

"Affirmative. Clinicaltrials.gov displays evidence that this clinical trial, initially put up on October 14th 2022, is actively enrolling patients. Around 150 individuals are being recruited from 28 distinct medical sites."

Answered by AI

Are there slots available for participation in this scientific experiment?

"Accurate. According to records located on clinicaltrials.gov, this trial is accepting participants and was first posted on October 14th 2022 with the latest update occurring November 24th of the same year."

Answered by AI

How many facilities are administering this experiment?

"This clinical trial is inviting patients across 28 sites, including Illinois CancerCare-Ottawa Clinic in Ottawa, McFarland Clinic PC - Ames in Ames, and McFarland Clinic PC-Jefferson in Jefferson."

Answered by AI

Have any further investigations been conducted utilizing nivolumab and cabozantinib?

"At present, 794 clinical trials concerning Treatment (nivolumab and cabozantinib) are in progress. 90 of these studies have reached Phase 3 with the majority taking place in Zürich, BE. However, 43554 sites worldwide are running trials for this particular intervention."

Answered by AI
~30 spots leftby Sep 2024