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Alkylating agents

Nivolumab + Chemoradiation for Nasopharyngeal Cancer

Phase 2

Waitlist Available

Led By Sue S Yom, MD, PhD

Research Sponsored by Sue Yom

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No distant metastasis as verified by one of the study investigators

Ability to tolerate radiation therapy (e.g. lie flat and hold position for treatment)

Must not have

Medical contraindication to radiation treatment

Known active hepatitis B or hepatitis C virus (HBV or HCV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies nivolumab in combination with chemoradiotherapy for nasopharyngeal cancer. Nivolumab is an antibody that may help fight cancer by targeting certain cells, and chemoradiotherapy is the combination of chemotherapy and radiation therapy. The goal of this trial is to see if nivolumab in combination with chemoradiotherapy may better treat patients with nasopharyngeal cancer.

Who is the study for?

Adults (≥18 years) with stage II-IVB nasopharyngeal carcinoma, who can undergo radiation therapy and have no severe allergies to immunotherapy or chemotherapy. They must not have other active cancers, untreated brain metastases, recent monoclonal antibody treatment, or certain autoimmune diseases. Participants need functioning major organs and agree to use effective contraception.

What is being tested?

The trial is testing the effectiveness of combining nivolumab (a type of immunotherapy that targets cancer cells) with chemoradiotherapy (cisplatin plus radiation therapy) in treating patients with nasopharyngeal cancer. The goal is to see if this combination works better than standard treatments alone.

What are the potential side effects?

Possible side effects include immune-related reactions affecting various organs, infusion-related symptoms, fatigue, liver function changes, blood cell count variations which could increase infection risk. There may also be typical side effects from chemotherapy and radiation like nausea and skin irritation.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread to distant parts of my body, as confirmed by a study investigator.

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I can lie flat and stay still for radiation therapy.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I cannot undergo radiation treatment due to health reasons.

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I have an active hepatitis B or C infection.

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I have not had any radiation therapy in the last 7 days.

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I have an autoimmune disease that needed treatment in the last 2 years.

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I have untreated brain metastases.

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I've had a severe allergic reaction to a monoclonal antibody or any study drug component before.

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I have not had a live-virus vaccine in the last 30 days.

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I do not have active diverticulitis, abdominal infections, blockages, or widespread cancer in my abdomen.

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I've had radiation in the head/neck area that overlaps with planned treatment.

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I have not received treatments targeting immune system checkpoints.

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I have never needed steroids for lung inflammation.

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I have not had signs of infection in the last 2 weeks.

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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of completion of all adjuvant immunotherapy

Secondary study objectives

Change in scores on the Functional Assessment of Cancer Therapy - Nasopharyngeal Cancer (FACT-NP)

Distant Metastasis (DM) Rate

Loco-regional Control (LRC) Rate

+5 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: Nivolumab + chemoradiationExperimental Treatment3 Interventions

Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Cisplatin

2013

Completed Phase 3

~3120