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Immunotherapy + Radiation for Throat Cancer
Phase 2
Recruiting
Led By Maura L Gillison
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have radiographically evident measurable disease at the primary site or at nodal stations per response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]) 1.1 documented by diagnostic quality CT or magnetic resonance imaging (MRI) of the neck with contrast within 28 days prior to registration; a FDG-PET/CT of the neck performed for the purposes of radiation planning is acceptable as a substitute if the CT is of diagnostic quality
Clinical American Joint Committee on Cancer (AJCC) 7th edition stage T1N2a-N2CM0, T2N1-N2CM0, T3N0-N2CM0, equivalent to AJCC 8th edition stage 1 and 2 (T1 N2, T2 N1-N2, T3 N0-N2) excluding T1N0-N1 and T2N0 (Brian O'Sullivan et al. 2016)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years
Awards & highlights
Study Summary
This trialstudies how well immunotherapy and radiation work to treat advanced HPV+ throat cancer.
Who is the study for?
This trial is for adults with advanced HPV-positive oropharyngeal squamous cell carcinoma. Participants must have certain blood counts, organ function tests within normal ranges, and a confirmed diagnosis through specific tests. Pregnant women, those with other cancers (except some skin cancers), previous radiation in the same area, severe allergies to contrast material, active infections or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The study is testing the combination of two immunotherapy drugs—Ipilimumab and Nivolumab—with intensity-modulated radiation therapy to see if they improve outcomes for patients. The trial will also determine the best doses of these drugs when used together with radiation.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that can affect organs like the lungs or intestines, fatigue, allergic reactions to infusion of medication, skin rash and potential complications from high-energy x-rays used in radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be seen and measured on scans.
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My cancer is at a specific stage according to AJCC guidelines, not the earliest or very advanced.
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I have a new diagnosis of squamous cell carcinoma in my oropharynx.
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I had a throat exam by a specialist within the last 28 days.
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I can carry out all my normal activities without help.
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I can provide a sample of my tumor for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate (Phase II)
Dose limiting toxicity (DLT) (safety lead-in)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Acute toxicity profiles (Phase II)
Incidence of acute and chronic adverse events (Phase II)
Late toxicity profiles (Phase II)
+7 moreSide effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Vascular access complication
10%
Wound dehiscence
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab, IMRT)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,902 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,166 Total Patients Enrolled
Maura L GillisonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the neck but its original source is unknown.I have had a neck FDG-PET/CT scan within the last 28 days.I have not had chemotherapy for my current cancer but may have for another.My scans show cancer has spread below my collarbone.I have not received a live vaccine in the last 30 days.I've had a detailed chest scan within the last 28 days.My kidney function is normal, with creatinine levels below 1.5 mg/dl or clearance above 50 ml/min.I do not have severe health issues like recent heart failure, serious infections, lung problems, liver issues, or a weak immune system.I have a severe allergy to CT or PET scan dyes that can't be managed with medication.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I've had radiation in the same area as my current cancer.My cancer can be seen and measured on scans.My cancer is at a specific stage according to AJCC guidelines, not the earliest or very advanced.I have a new diagnosis of squamous cell carcinoma in my oropharynx.I had surgery to remove all visible signs of my cancer, including the primary site and lymph nodes.My tumor is positive for p16 and HPV according to specific tests.I had a throat exam by a specialist within the last 28 days.My hemoglobin level is at least 8.0 g/dl, possibly after receiving treatment.My cancer is located in my mouth, throat, or voice box.I can carry out all my normal activities without help.I can provide a sample of my tumor for testing.I have more than one primary cancer or tumors in both sides of a body part.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.I have lung inflammation not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab, IMRT)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 most patients using Intensity-Modulated Radiation Therapy to treat?
"Intensity-Modulated Radiation Therapy, which is often used to treat patients that have undergone anti-angiogenic therapy, can also help those struggling with conditions like malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Are there any available slots for volunteers in this experiment?
"That is correct. The clinical trial information available on clinicaltrials.gov reveals that the study is currently enrolling patients. This research was originally posted on 7/25/2019, and the most recent update occurred on 11/8/2022. Only 1 site is participating in this trial, but up to 180 patients may be enrolled."
Answered by AI
Has the FDA okayed Intensity-Modulated Radiation Therapy for use?
"Intensity-Modulated Radiation Therapy is rated as a 2 in terms of safety by our analysts at Power. This reflects the fact that, while there is some data supporting its safety, none supports its efficacy (as this is only a Phase 2 trial)."
Answered by AI
To date, how many individuals have taken part in this test?
"That is correct. The clinicaltrials.gov website lists this trial as currently recruiting patients. This study, which began recruitment on 7/25/2019, is admitting a total of 180 patients at 1 location."
Answered by AI
How does this new type of radiation therapy compare to other treatments?
"Intensity-Modulated Radiation Therapy is being investigated in 796 different clinical trials, 86 of which are Phase 3. While some of these studies are taking place in Pittsburgh, 43300 other locations across the world are also running trials for Intensity-Modulated Radiation Therapy."
Answered by AI
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