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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
No Placebo-Only Group

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)
Secondary study objectives
Cumulative incidence of local or distant relapse
Event-free survival (EFS)
Feasibility success of the induction regimen
+1 more
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Echocardiography
2013
Completed Phase 4
~11580
Computed Tomography
2017
Completed Phase 2
~2740
Radiation Therapy
2017
Completed Phase 3
~7250
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Chest Radiography
2018
N/A
~560
Cisplatin
2013
Completed Phase 3
~3120
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Nivolumab
2015
Completed Phase 3
~4010
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,010 Total Patients Enrolled
72 Trials studying Nasopharyngeal Carcinoma
14,015 Patients Enrolled for Nasopharyngeal Carcinoma
Robyn D GartrellPrincipal InvestigatorChildren's Oncology Group
~33 spots leftby Dec 2026
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