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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

Awards & 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