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Chemotherapy
Chemoradiotherapy + Nivolumab for Oropharyngeal Carcinoma
Phase 2
Waitlist Available
Led By Michelle Mierzwa, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Due to the potential for serious adverse reactions in breastfed infants from carboplatin/paclitaxel and nivolumab, women are advised not to breast-feed during treatment with carboplatin/paclitaxel or nivolumab
- Age ≥ 18;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after completion of study treatment
Awards & highlights
Study Summary
This trial is testing whether adding the drug nivolumab to standard radiation and chemotherapy can improve the chances of surviving for at least two years without the disease progressing.
Who is the study for?
Adults with high-risk HPV-related squamous cell carcinoma of the oropharynx, without distant metastases. They must have a good performance status, adequate organ function, and agree to use effective contraception. Excluded are those with recent heart issues, active infections like TB or hepatitis B/C, prior treatments for the study cancer within 3 years (except non-melanomatous skin cancer), uncontrolled health conditions such as diabetes or adrenal insufficiency, known allergies to trial drugs, and women who are breastfeeding.Check my eligibility
What is being tested?
The trial is testing if adding nivolumab to standard care (fractionated radiation therapy plus carboplatin/paclitaxel) improves two-year progression-free survival in patients with high-risk HPV-related head and neck cancer. Fractionated radiation means treatment is given over multiple days.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can cause inflammation in organs; infusion reactions; blood disorders; fatigue; digestive issues like nausea and diarrhea; increased risk of infection due to immunosuppression from nivolumab; allergic reactions to any of the medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not breastfeeding while receiving treatment.
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I am 18 years old or older.
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My throat cancer is HPV positive or has p16 positive cells.
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My cancer is at stage III or I have matted lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Correlation of mid-treatment FDG-PET scans with post-treatment PET-CT.
Acute Coryza
Incidence of late toxicity
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab, Carboplatin/Paclitaxel, RadiotherapyExperimental Treatment4 Interventions
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Radiation Therapy
2017
Completed Phase 3
~7250
Nivolumab
2014
Completed Phase 3
~4750
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,071 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,006 Total Patients Enrolled
Michelle Mierzwa, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe lung condition that requires hospital care right now.I am not breastfeeding while receiving treatment.I am not allergic to nivolumab, carboplatin, or paclitaxel.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My diabetes is not well-controlled despite trying to manage it with fasting and medication adjustments.I agree to use effective birth control during and up to 5 months after the study.I had a PET/CT scan for cancer staging within the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I am breastfeeding and not willing to stop during the trial.I do not have uncontrolled diarrhea.You have a serious and ongoing health condition.My adrenal glands are not working properly and it's not under control.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I had a major heart attack in the last 3 months.I am not pregnant or willing to use birth control during the study.I have an active tuberculosis infection.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.I have not had treatment for this cancer before, but I may have had chemotherapy for another cancer over 3 years ago.I have not had radiation in the same area where my current cancer is.I do not have an active bacterial or fungal infection requiring antibiotics.I do not have AIDS or my CD4+ count is above 350.I have not taken immunosuppressive drugs or steroids, except for short treatments, in the last 7 days.My throat cancer is HPV positive or has p16 positive cells.My cancer is at stage III or I have matted lymph nodes.My kidney function tests are within normal range.I have a history of or currently have non-infectious lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
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.
Are there vacancies still accessible to prospective participants of this experiment?
"Affirmative. According to information on clinicaltrials.gov, this research initiative began recruiting participants in September 2019 and is still searching for enrollees as of December 2021. A total of 40 individuals need be enrolled at one medical centre."
Answered by AI
What maladies could be assisted by Nivolumab treatment?
"Nivolumab is an effective form of treatment for malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."
Answered by AI
How many participants are being recruited for this experiment?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants; the trial was originally posted on September 5th 2019 and concluded its last revision on December 15th 2021. 40 individuals are being sought out from one medical facility for enrolment in this study."
Answered by AI
Could you expound on the findings of prior experiments related to Nivolumab?
"Currently, 1827 studies are underway regarding Nivolumab. Of those trials, 400 of them are in the final clinical trial phase (Phase 3). Although most research is conducted out of Shanghai, nearly 100 thousand other sites worldwide offer this treatment."
Answered by AI
What safety protocols are observed when administering Nivolumab?
"Although no efficacy has been confirmed, Nivolumab scored a 2 in our safety assessment due to the presence of some clinical data supporting its security."
Answered by AI
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