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Nivolumab for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Trisha Wise-Draper, MD
Research Sponsored by Trisha Wise-Draper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test whether the immunotherapy drug nivolumab is safe and effective in people with head and neck cancer who have already had surgery and radiation.

Who is the study for?
This trial is for individuals who have had head and neck cancer, were treated with radiation (and possibly chemotherapy), and then underwent surgery to remove the cancer. They should be in good health otherwise, able to undergo scans, provide tissue samples, and have no other treatment options.
What is being tested?
The study is examining the effectiveness of Nivolumab as an additional treatment after surgical removal of head and neck cancer in patients who've already received radiation therapy. It aims to see if this drug can improve outcomes post-surgery.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs like lungs or intestines, skin rash, hormone gland problems (like thyroid), fatigue, infusion reactions, and increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
0%
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

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: NivolumabExperimental Treatment1 Intervention
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
193 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,530 Total Patients Enrolled
Trisha Wise-Draper, MDPrincipal InvestigatorUniversity of Cincinnati
2 Previous Clinical Trials
59 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03355560 — Phase 2
Head and Neck Cancers Research Study Groups: Nivolumab
Head and Neck Cancers Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03355560 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355560 — Phase 2
~5 spots leftby Nov 2025
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