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Immunotherapy + Radiation for Throat Cancer

Phase 2

Waitlist Available

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)

Must not have

Carcinoma of the neck of unknown primary site origin (even if p16 positive)

Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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My cancer is in the neck but its original source is unknown.

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My scans show cancer has spread below my collarbone.

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I do not have severe health issues like recent heart failure, serious infections, lung problems, liver issues, or a weak immune system.

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I have a severe allergy to CT or PET scan dyes that can't be managed with medication.

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I've had radiation in the same area as my current cancer.

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I had surgery to remove all visible signs of my cancer, including the primary site and lymph nodes.

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My cancer is located in my mouth, throat, or voice box.

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I have more than one primary cancer or tumors in both sides of a body part.

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I have lung inflammation not caused by an infection.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity (DLT) (safety lead-in)

Secondary study objectives

Acute toxicity profiles (Phase II)

Incidence of acute and chronic adverse events (Phase II)

Late toxicity profiles (Phase II)

+1 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741

30%

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%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

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.

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

~2140

Ipilimumab

FDA approved

Nivolumab

FDA approved