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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 • NCT0204153357%
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%
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%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
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
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
557 Previous Clinical Trials
32,874 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,474 Total Patients Enrolled
Tanguy Lim-Seiwert, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease, but it's under control or not expected to come back.My cancer can be measured by scans or physical exams.A team of doctors has approved me for surgery.I can carry out all my daily activities without help.My oxygen levels stay above 90% whether I'm resting or walking.My cancer is a type of squamous cell carcinoma located in the head or neck area.I have another cancer, but it's either under control or not life-threatening within the next 3 years.My kidney function, measured by creatinine or its clearance, is within or above the normal range.I am not pregnant or nursing.I do not have HIV.I have an untreated squamous cell carcinoma of the head or neck that can be surgically removed.I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.My organ and bone marrow functions are normal.I had surgery to remove cancer that spread, within the last 3 months.I have had chemotherapy for head and neck cancer, either as a new or recurrent case.I agree to use contraception and not donate sperm during and 7 months after treatment.I have a recurring squamous cell carcinoma in my head or neck that can be removed with surgery.I have not had specific immune therapies or live vaccines recently.I do not have any severe illnesses or recent major heart issues that would interfere with the study.My brain metastases are stable, I've been off steroids or on a low dose for 2 weeks, and I don't have carcinomatous meningitis.I have an active hepatitis B or C infection.I have EBV+ nasopharyngeal cancer.I am a man and my partner and I do not plan to use birth control.I have not received a live vaccine in the last 30 days.I understand the study, its risks, and I'm willing to sign the consent form.I am older than 18 years.I have brain metastases that are not currently under control.
Research Study Groups:
This trial has the following groups:- Group 1: Reccurence of SCCHN
- Group 2: Newly diagnosed SCCHN
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the combination of Nivolumab 480mg and surgical resection pose any health risks for individuals?
"Given that this is a Phase 2 trial, and there is some data available to support safety but none regarding efficacy, our team at Power assigned Nivolumab 480mg and surgical resection a score of 2."
Answered by AI
Are there still opportunities for individuals to become involved with this experiment?
"As suggested by clinicaltrials.gov, this trial is not currently actively seeking new participants; however, it was originally posted on July 8th 2019 and last updated February 25th 2022. Fortunately, there are 3276 other trials that patients can join at the present time."
Answered by AI
Does this research represent a pioneering effort in its field?
"Currently, 718 active trials for Nivolumab 480mg and surgical resection are in progress across 2356 cities spanning 49 nations. This therapeutic combination was first tested back in 2012 by Ono Pharmaceutical Co. Ltd's Phase 1 & 2 drug approval trial which enrolled 659 participants. Since then, a further 250 studies have been conducted on the subject matter."
Answered by AI
What maladies are ameliorated through the combination of Nivolumab 480mg and surgical resection?
"Nivolumab 480mg and surgical resection are commonly utilized to treat malignant neoplasms. However, this duo of treatments may also prove effective for certain cases of unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
What is the total number of participants in this clinical trial?
"At this time, the recruitment period for this research study has closed. The posting was initially made on July 8th 2019 and last revised on February 25th 2022. Fortunately, there are still many other trials that may match your needs; 3008 studies recruiting patients with carcinoma squamous cell, as well as 718 investigations involving Nivolumab 480mg in combination with surgical resection currently admit participants."
Answered by AI
Has Nivolumab 480mg been explored in conjunction with surgical removal during previous research studies?
"At present, 718 clinical trials assessing the effectiveness of Nivolumab 480mg in combination with surgical resection are underway. Of these trials, 82 have progressed to Phase 3. Switzerland's Zürich is home to the majority of these studies; however, research locations span 40285 around the world."
Answered by AI
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