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Checkpoint Inhibitor

Preoperative Nivolumab for Head and Neck Cancers

Phase 2
Waitlist Available
Led By Tanguy Lim-Seiwert, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field.
Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing nivolumab, a drug that may help the immune system fight cancer, before surgery in people with SCCHN.

Who is the study for?
This trial is for adults with newly diagnosed or recurrent head and neck squamous cell carcinoma (SCCHN) that can be surgically removed. Participants must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have autoimmune diseases, uncontrolled illnesses, recent live vaccines, prior treatments with certain immunotherapies or chemotherapy for SCCHN.Check my eligibility
What is being tested?
The trial tests the effectiveness of Nivolumab (an immune checkpoint inhibitor) given before surgery in patients with primary untreated or recurrent/metastatic SCCHN. The goal is to see if this preoperative treatment improves outcomes compared to standard care.See study design
What are the potential side effects?
Possible side effects of Nivolumab include fatigue, skin reactions, inflammation of organs like lungs and intestines (pneumonitis and colitis), hormonal gland problems (like thyroid dysfunction), infusion-related reactions, and potential worsening of underlying autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a recurring squamous cell carcinoma in my head or neck that can be removed with surgery.
Select...
A team of doctors has approved me for surgery.
Select...
I can carry out all my daily activities without help.
Select...
My oxygen levels stay above 90% whether I'm resting or walking.
Select...
My kidney function, measured by creatinine or its clearance, is within or above the normal range.
Select...
I have an untreated squamous cell carcinoma of the head or neck that can be surgically removed.
Select...
I am older than 18 years.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility as measured by number of participants with successful completion of preoperative treatment and no extended treatment-related delays
Safety as measured by number of participants with drug-related adverse events
Secondary outcome measures
Major pathologic response rate
Progression free survival (PFS)
Radiographic response rate

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%
Hyponatraemia
14%
Rash
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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
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

2Treatment groups
Experimental Treatment
Group I: Reccurence of SCCHNExperimental Treatment1 Intervention
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Group II: Newly diagnosed SCCHNExperimental Treatment1 Intervention
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab 480mg and surgical resection
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,073 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,806 Total Patients Enrolled
Tanguy Lim-Seiwert, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03878979 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Reccurence of SCCHN, Newly diagnosed SCCHN
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03878979 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878979 — Phase 2
~4 spots leftby Jun 2025
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