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Nivolumab + Radiation Therapy for Oropharyngeal Cancer

Phase 2
Waitlist Available
Led By Robert Ferris, MD, PhD
Research Sponsored by Robert L. Ferris, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have carcinoma of the oropharynx associated with HPV
No prior radiation above the clavicles
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1-year and at 2 year post-surgery
Awards & highlights

Study Summary

This trial is testing a new combination of treatments for cancer in the back of the throat. The new combo will be compared to the current standard of care, which has serious side effects but is usually effective. The goal is to find a new combo that is just as effective but has fewer side effects.

Who is the study for?
This trial is for adults with HPV-related oropharyngeal cancer who haven't had radiation above the clavicles, have acceptable organ function, and no distant metastases. They should be non-pregnant, not breastfeeding, and without serious illnesses that could affect treatment. Smokers are eligible based on specific criteria.Check my eligibility
What is being tested?
The study tests a new treatment combining Nivolumab (an immunotherapy drug) with reduced radiation against standard chemoradiotherapy to see if it's equally effective but has fewer side effects and improves quality of life in patients with oropharyngeal cancer.See study design
What are the potential side effects?
Nivolumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormonal gland problems like thyroid issues, fatigue, and infusion reactions. Radiotherapy can lead to skin irritation at the site of treatment and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My throat cancer is linked to HPV.
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I have not had radiation therapy above my collarbone.
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My cancer has not spread to distant parts of my body.
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I am 18 years old or older.
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My diabetes, blood pressure, and any infections are under control.
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I have a new diagnosis of a specific throat cancer that can be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My throat cancer is confirmed to be p16 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-year and at 2-year post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1-year and at 2-year post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PEG tube dependence
Progression-free survival (PFS)
Secondary outcome measures
Adverse Events Related to Treatment
Distant disease recurrence
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
+7 more
Other outcome measures
Antigen-specific immune response to Human papillomavirus (HPV)
Determination of Tumor genomics
Determination of oral Human papillomavirus (HPV) DNA
+2 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT03122509
8%
Gastrointestinal disorders - Other, specify
8%
Hyperglycemia
4%
Fever
4%
Alanine aminotransferase increased
4%
Enterocolitis infectious
4%
Gen disorders & admin site conditions Other, spec
4%
Aspartate aminotransferase increased
4%
Platelet count decreased
4%
Colitis
4%
Ileus
4%
Pneumothorax
4%
Rectal hemorrhage
4%
Sepsis
4%
Upper respiratory infection
4%
Alkaline phosphatase increased
4%
Biliary tract infection
4%
Blood bilirubin increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation
Durvalumab and Tremelimumab Plus Ablation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiotherapy (RT) + Nivolumab InjectionExperimental Treatment2 Interventions
RT of 45 or 50 Gy in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at 240 mg every 2 weeks during radiotherapy, and at 480 mg every 4 weeks for 6 doses after radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab Injection
2017
Completed Phase 2
~410
Radiotherapy (RT)
2017
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Robert L. Ferris, MD, PhDLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Robert FerrisLead Sponsor
6 Previous Clinical Trials
233 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,494 Total Patients Enrolled

Media Library

Radiotherapy (RT) Clinical Trial Eligibility Overview. Trial Name: NCT03715946 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Radiotherapy (RT) + Nivolumab Injection
Squamous Cell Carcinoma Clinical Trial 2023: Radiotherapy (RT) Highlights & Side Effects. Trial Name: NCT03715946 — Phase 2
Radiotherapy (RT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03715946 — Phase 2

Frequently Asked Questions

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

Are there any positions available for participants in this experiment?

"The clinical trial in question is no longer actively recruiting patients, as the last update on trials.gov was over 3 months ago. That being said, there are still 3548 other ongoing trials that are looking for volunteers right now."

Answered by AI

Do we have a history of using Radiotherapy (RT) for this purpose?

"As of right now, 747 clinical trials are being conducted that focus on radiotherapy (RT). Out of those 747 trials, 82 are currently in phase 3. Although a majority of the trials for RT are located in Basel, BE, 40325 different locations around the world are running studies for this treatment."

Answered by AI

What are the most common indications for Radiotherapy (RT)?

"Radiotherapy is most often used to treat cancer, but it can also be useful for managing other conditions like unresectable melanoma or squamous cell carcinoma."

Answered by AI

What are the aims of this research?

"According to the study's sponsor, Bristol-Myers Squibb, the primary outcome of this trial will be dependence on PEG tubes. This will be measured over a 3 year period from the beginning of treatment (post surgery). In addition to the primary outcome, other secondary outcomes being evaluated include Overall Survival (OS), which is defined as The length of time (in months) from the start of treatment patients remain alive., Adverse Events Related to Treatment, which is defined as Number of patients experiencing Adverse Events and Serious Adverse Events related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE)"

Answered by AI

How many people total will be participating in this experiment?

"Unfortunately, this particular clinical trial is no longer recruiting patients. The trial was originally posted on November 1st, 2018 but the most recent edit occurred on March 24th, 2022. However, there are still 2801 trials searching for carcinoma patients and 747 studies involving Radiotherapy (RT) that are currently enrolling participants."

Answered by AI

What is the unique aspect of this clinical trial?

"Radiotherapy (RT) has been under investigation for about a decade. The first official trial was completed in 2010 by Medarex and, after being successful, led to Radiotherapy's Phase 1 drug approval. Now, there are over 700 active trials in more than 2300 cities across 50 nations."

Answered by AI

Are there long-term risks associated with RT treatments?

"Radiotherapy (RT) has received a score of 2 because, while there is some evidence supporting its safety from Phase 2 trials, there is no data backing its efficacy."

Answered by AI
~7 spots leftby Mar 2025