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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer has not spread to distant parts of my body, as confirmed by a study investigator.
Select...
I can lie flat and stay still for radiation therapy.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of completion of all adjuvant immunotherapy
Secondary outcome measures
Change in scores on the Functional Assessment of Cancer Therapy - Nasopharyngeal Cancer (FACT-NP)
Distant Metastasis (DM) Rate
Loco-regional Control (LRC) Rate
+5 moreTrial 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
~1940
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,474 Total Patients Enrolled
National University Cancer Institute, SingaporeUNKNOWN
1 Previous Clinical Trials
244 Total Patients Enrolled
Sue YomLead Sponsor
2 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo radiation treatment due to health reasons.I have no health conditions that prevent me from receiving immunotherapy.My biopsy confirms I have stage II-IV nasopharyngeal cancer, not the keratinizing type.My scans within the last 2 months show stage II to IVB nasopharyngeal cancer.My cancer has not spread to distant parts of my body, as confirmed by a study investigator.I have an active hepatitis B or C infection.I have not had any radiation therapy in the last 7 days.I have an autoimmune disease that needed treatment in the last 2 years.I have another type of cancer that could be life-threatening.I have untreated brain metastases.I am approved for chemoradiation for my nasopharyngeal cancer by a study investigator.All side effects from my previous cancer treatments have mostly gone away.My liver, blood, and kidney functions are good enough for cisplatin and nivolumab treatment.I have not had a live-virus vaccine in the last 30 days.I have taken antibiotics by mouth or IV within the last 2 weeks.I've had radiation in the head/neck area that overlaps with planned treatment.I am 18 years old or older.I haven't had cancer treatment or major surgery in the last 28 days.I've had a severe allergic reaction to a monoclonal antibody or any study drug component before.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I do not have active diverticulitis, abdominal infections, blockages, or widespread cancer in my abdomen.I have active tuberculosis or a high risk of its reactivation.I have not received treatments targeting immune system checkpoints.I can lie flat and stay still for radiation therapy.I have never needed steroids for lung inflammation.I have not had signs of infection in the last 2 weeks.I am fully active or can carry out light work.I am not taking any medications that are not allowed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + chemoradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the common afflictions that Radiation Therapy is used as a treatment for?
"Radiation therapy is often used to treat metastatic ureter urothelial carcinoma, but it can also help patients with metastatic hepatocellular carcinoma, malignant melanoma of the skin, and neoplasm metastasis."
Answered by AI
Are there any other case examples where Radiation Therapy has been used?
"Radiation Therapy is being researched in 1424 different trials, with 355 of those being in the critical third phase. The large majority of these studies are based in Mexico City and Maryland; however, there are 76822 total locations running clinical trials for this treatment."
Answered by AI
Has the FDA greenlit radiation therapy?
"Phase 2 trials have less data supporting their safety relative to Phase 3 trials. Therefore, our team has given Radiation Therapy a score of 2."
Answered by AI
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