← Back to Search

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Incidence of adverse events

ORR

Overall survival (OS)

+2 more

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 at baseline, every 3 cycles on treatment, and every 8-12 weeks during follow-up. Patients may also undergo collection of blood samples at baseline, day 1 of cycle 2, and at progression or end of treatment.

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 at baseline, every 3 cycles on treatment, and every 8-12 weeks during follow-up. Patients may also undergo collection of blood samples at baseline, day 1 of cycle 2, and at progression or end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Biospecimen Collection

2004

Completed Phase 2

~1700

Ipilimumab

2014

Completed Phase 3

~2620

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Cabozantinib S-malate

2013

Completed Phase 2

~470

Computed Tomography

2017

Completed Phase 2

~2720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,391 Total Patients Enrolled

Glenn J HannaPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

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

Is enrollment still open for this research project?

"Per the information presented on clinicaltrials.gov, this research study is actively recruiting subjects to participate. It was first posted in June of 2024 and underwent its last update near the end of September 2023."

Answered by AI

Has the Arm B (nivolumab, ipilimumab, cabozantinib) treatment regimen been given regulatory clearance?

"Our analysis of Arm B (nivolumab, ipilimumab, cabozantinib) resulted in a 2 rating due to the lack of efficacy data from Phase 2 trials and just some evidence suggesting safety."

Answered by AI

What is the aggregate participation rate for this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov attests to the fact that, as of June 14th 2024 and last updated September 29th 2023, this trial is actively recruiting a cohort of 50 subjects from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

2024. "Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05904080.

All > Nasopharyngeal Carcinoma > Spokane