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Chemotherapy

Nivolumab + Chemotherapy for Nasopharyngeal Cancer

Phase 2

Recruiting

Led By Robyn D Gartrell

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

Patients must be ≤ 21 years of age at the time of study enrollment

Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 (within 7 days prior to start of protocol therapy)

Must not have

Patients who received prior radiotherapy to the head or neck

Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

"This trial is testing a combination of nivolumab with chemotherapy drugs and radiation therapy to treat patients with nasopharyngeal cancer. The goal is to see if this combination can help the immune

Who is the study for?

This trial is for individuals up to 21 years old with newly diagnosed stage II-IV nasopharyngeal carcinoma. Participants need a certain level of physical health (Lansky or Karnofsky score ≥60%), adequate platelet count, and normal kidney function. It's recommended but not required to provide tumor tissue for research.

What is being tested?

The study tests the effectiveness of Nivolumab combined with chemotherapy drugs Gemcitabine and Cisplatin, plus radiation therapy in treating nasopharyngeal cancer. The goal is to see if this combination helps the immune system fight cancer better.

What are the potential side effects?

Potential side effects include typical reactions from immunotherapy like fatigue, skin issues, or inflammation in organs; chemotherapy-related nausea, hair loss, and low blood cell counts; and radiation therapy effects such as skin irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

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

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I am 21 years old or younger.

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My kidney function, measured by creatinine clearance or GFR, is normal or near normal.

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My nasopharyngeal cancer is at stage II-IV.

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I can do most activities but may need help.

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My hepatitis B is under control, or I've been cured of hepatitis C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my head or neck.

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I had cancer treatment in the last 3 years and am now in remission.

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I have been diagnosed with an immune system deficiency.

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I have an autoimmune disease treated within the last 2 years.

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I have had pneumonitis that needed steroids or have it now.

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I have an active infection of HIV, hepatitis B, hepatitis C, or tuberculosis.

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I have had an organ or bone marrow transplant.

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I am not pregnant and agree to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 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

Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)

Secondary outcome measures

Cumulative incidence of local or distant relapse

Event-free survival (EFS)

Feasibility success of the induction regimen

+1 more

Other outcome measures

EFS

EFS in patients receiving intensity modulated radiation therapy with those who receive proton therapy

Incidence of grade 3 or higher adverse events

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, gemcitabine, cisplatin, radiattion)Experimental Treatment17 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Computed Tomography

2017

Completed Phase 2

~2740

Radiation Therapy

2017

Completed Phase 3

~7250

Echocardiography

2013

Completed Phase 4

~11580

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020

Chest Radiography

2018

N/A

~560

Cisplatin

2013

Completed Phase 3

~2360

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Multigated Acquisition Scan

2015

Completed Phase 3

~270

Nivolumab

2014

Completed Phase 3

~5220

Positron Emission Tomography

2011

Completed Phase 2

~2200

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,842 Previous Clinical Trials

41,002,950 Total Patients Enrolled

70 Trials studying Nasopharyngeal Carcinoma

13,838 Patients Enrolled for Nasopharyngeal Carcinoma

Robyn D GartrellPrincipal InvestigatorChildren's Oncology Group

~33 spots leftby Dec 2026

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