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Kinase Inhibitor
Immunotherapy +/− Targeted Therapy for Nasopharyngeal Cancer
Phase 2
Recruiting
Led By Glenn J Hanna
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how well immunotherapy and targeted therapy can treat recurrent or incurable nasopharyngeal cancer.
Who is the study for?
Adults (18+) with nasopharyngeal cancer that's returned, spread, or is incurable can join. They should have had no more than two prior treatments and not been on VEGFR targeted therapy. A good performance status (ECOG 0-2) and certain blood counts are required. The cancer must be measurable by scans or physical exam.
What is being tested?
The trial tests nivolumab and ipilimumab immunotherapy combined with cabozantinib against the same immunotherapy without cabozantinib to see if it helps control nasopharyngeal cancer better. These drugs may boost the immune system to fight cancer and block proteins that help cancer grow.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, skin issues, digestive problems like diarrhea, liver enzyme changes, hormone gland problems (like thyroid), and potential increase in bleeding risk due to cabozantinib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Incidence of adverse events
ORR
Overall survival (OS)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (nivolumab, ipilimumab, cabozantinib)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may continue with cabozantinib S-malate after 2 years per treating investigator. Patients undergo CT or MRI and collection of blood samples throughout the trial.
Group II: Arm A (nivolumab, ipilimumab)Active Control5 Interventions
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Cabozantinib S-malate
2013
Completed Phase 2
~470
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,415 Total Patients Enrolled
Glenn J HannaPrincipal InvestigatorAlliance for Clinical Trials in Oncology
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