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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Jonathan Schoenfeld, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Only patients 18 years and older are eligible. There is no upper age limit but the patients must be able to medically tolerate the regimen. Adverse event data are currently unavailable on the use immune checkpoint blockade for participants < 18 years of age, and thus children are excluded from this study

Participants must have normal organ and marrow function as defined below: Laboratory parameters: WBC ≥ 2000/uL, Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin (Hgb) ≥ 9 g/dL; Hgb-A1C ≤ 7.5%; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); Bilirubin ≤ 2.5 × ULN (≤ 4 × ULN for subjects with Gilbert's disease); Alkaline phosphatase ≤ 2.5 × ULN; Creatinine ≤ 1.5 × ULN

Must not have

Has received a live vaccine within 28 days of planned start of study therapy

Prior chemotherapy within the last 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying nivolumab and ipilimumab to see how well they work in treating patients with squamous cell carcinoma of the oral cavity.

Who is the study for?

Adults with squamous cell carcinoma of the oral cavity, who are fit for surgery and have not received certain cancer treatments or have active infections. Participants must be able to tolerate anesthesia, have no history of severe allergies to trial drugs, and women of childbearing age must use effective contraception.

What is being tested?

The study is testing nivolumab alone or combined with ipilimumab against standard surgical care in treating oral cavity squamous cell carcinoma. It aims to see if these drugs can improve outcomes before patients undergo surgery.

What are the potential side effects?

Potential side effects include immune-related reactions that could affect organs, skin rashes, hormone gland problems (like thyroid dysfunction), fatigue, and infusion-related reactions. There may also be risks associated with combining these drugs.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and can medically handle the treatment.

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My blood tests show normal organ function and I don't have severe anemia or diabetes.

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I can carry out all my self-care but cannot do heavy physical work.

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My oral cancer is confirmed and larger than 2 cm or has spread to my lymph nodes.

Exclusion Criteria

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

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I have not received a live vaccine in the last 28 days.

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I have had chemotherapy in the past 2 years.

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I have lung inflammation not caused by infection, treated with steroids.

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I am positive for HIV, Hepatitis B, or Hepatitis C.

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I am not receiving any other cancer treatments while in this study.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.

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I have previously received immunotherapy targeting PD-1 or CTLA-4.

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I have had radiation therapy to my head or neck.

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My cancer has spread to areas below my collarbone or to my bones, brain, or spinal canal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

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

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants With a Volumetric Response Rate to Treatment

Safety and Tolerability of Protocol Treatment

Secondary study objectives

Participant One Year Progression-Free Survival Percentage

Participant Overall Survival Percentage

Percentage of Participants Demonstrating Objective Response Using RECIST Criteria

+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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

Group I: Nivolumab With IpilimumabExperimental Treatment3 Interventions

* Nivolumab to be delivered at a pre-determine dose for two weeks * Ipilimumab to be delivered at a pre-determine dose for one week * Blood Sample Collected * Standard of Care Surgery

Group II: NivolumabExperimental Treatment2 Interventions

* Nivolumab to be delivered at a pre-determine dose for two weeks * Blood Sample Collected * Standard of Care Surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015