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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 2 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients with Grade 3 and 4 adverse events of nivolumab
Secondary outcome measures
Disease free survival
Percentage of patients any grade adverse events of nivolumab

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
2,638 Previous Clinical Trials
4,128,475 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate on the research already done with Nivolumab?

"Presently, there are 718 active studies involving Nivolumab. Out of those trials 82 have advanced to phase 3 and 40237 trial sites across the world are running research for this medication with most located in Basel, BE."

Answered by AI

Is this experiment a pioneering endeavor in its field?

"At present, 718 active clinical trials related to Nivolumab are being conducted in 2354 cities and 49 countries. This drug has been studied heavily since its initial trial sponsored by Ono Pharmaceutical Co. Ltd in 2012 which included 659 participants completing Phase 1 & 2 of the approval process. Subsequently, a total of 252 subsequent studies have taken place."

Answered by AI

Has Nivolumab obtained regulatory approval from the Food and Drug Administration?

"Taking into consideration the Phase 2 nature of this experiment, our team has assigned Nivolumab a safety rating of 2 due to existing evidence regarding its security profile but lack thereof pertaining to efficacy."

Answered by AI

What conditions is Nivolumab typically administered to alleviate?

"Nivolumab can be employed to treat potentially deadly neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Is enrollment still open for this investigation?

"Unfortunately, this clinical trial is not presently accepting participants; the last update was made on October 3rd 2022. If you're in search of other studies related to head and neck cancer, there are 481 trials that may suit your needs; similarly, 718 trials using Nivolumab as an intervention are actively recruiting right now."

Answered by AI

How many individuals have enrolled in this clinical trial?

"Unfortunately, the trial is currently not accepting any more applicants. It was posted on December 6th 2017 and last updated October 3rd 2022. If you are searching for clinical studies related to head and neck cancer, there are 481 I trials; if Nivolumab interests you, then 718 studies may be suitable."

Answered by AI
~5 spots leftby Apr 2025