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Monoclonal Antibodies

Radiation Therapy + Immunotherapy for Head and Neck Cancer

Phase 2 & 3

Waitlist Available

Led By Loren K Mell

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have locoregionally advanced head and neck squamous cell carcinoma (HNSCC)

For patients with oropharyngeal or unknown primaries: p16 determination by immunohistochemistry confirmed by central pathology review

Must not have

Prior invasive malignancy within the past 3 years (except for non-melanomatous skin cancer, and early stage treated prostate cancer); synchronous head and neck primaries are ineligible

Zubrod performance status >= 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well radiation therapy works with durvalumab or cetuximab to treat patients with head and neck cancer that has spread.

Who is the study for?

This trial is for adults with advanced head and neck cancer who can't use cisplatin. They must have untreated, unresected squamous cell carcinoma in specific regions (larynx, hypopharynx, oropharynx, oral cavity) and meet health criteria like blood counts and organ function tests. Pregnant women are excluded, as are those with recent cancers (except certain skin/prostate cancers), severe illnesses or allergies to the drugs tested.

What is being tested?

The study compares radiation therapy combined with durvalumab (an immunotherapy drug) versus cetuximab (another type of monoclonal antibody). It aims to see which combination works better for shrinking tumors in patients who cannot take cisplatin.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect organs, infusion reactions from the antibodies used, fatigue, skin rashes and allergic responses. Durvalumab may also cause changes in liver enzymes and cetuximab might trigger acne-like rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced cancer in my head or neck area.

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My throat cancer is p16 positive, confirmed by a specialized lab.

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I have submitted tissue samples for review and analysis to UCSF.

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I cannot take cisplatin due to health reasons.

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I have a confirmed, untreated squamous cell carcinoma in my head or neck area.

Exclusion Criteria

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

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I haven't had cancer (except skin or early prostate cancer) in the last 3 years.

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I need help with my personal care and cannot do any physical work.

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My body weight is 30 kg or less.

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I have received an organ transplant from another person.

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

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I have received immunotherapy or systemic therapy for my cancer.

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I have not had major surgery in the last 28 days.

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I do not have major heart, lung, liver, or autoimmune diseases.

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My cancer has spread to distant parts of my body.

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I do not have uncontrolled high blood pressure, serious heart rhythm problems, severe stomach issues, or active infections like TB or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

(Lead-in) Number of Participants With Dose-limiting Toxicity (DLT)

Overall Survival (Percentage of Participants Alive)

Progression-free Survival (Percentage of Participants Alive Without Progression)

Secondary study objectives

Change in Quality of Life (QOL) Analysis

Change in Swallowing QOL Using Total Composite M. D. Anderson Dysphagia Inventory (MDADI) Score

Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)

+5 more

Other study objectives

Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales

Secondary Biomarker Analysis

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (durvalumab, radiation therapy)Experimental Treatment5 Interventions

Patients receive durvalumab IV over 60 minutes every 4 weeks. Treatment repeats every 4 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients undergo IMRT 5 fractions per week for up to 7 weeks.

Group II: Arm I (cetuximab, radiation therapy)Active Control5 Interventions

Patients receive cetuximab IV weekly over 60-120 minutes. Treatment repeats every week for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Beginning 5-7 days after first cetuximab dose, patients undergo IMRT 5 fractions per week for up to 7 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2140

Durvalumab

2017

Completed Phase 2

~3750