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Nivolumab + Lirilumab for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Glenn J. Hanna, 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
Subject must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck (including any primary site, such as oral cavity, oropharynx, larynx or hypopharynx, and nasopharyngeal carcinoma)
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27.2 months post salvage surgery, up to 28 months total.
Awards & highlights
Study Summary
This trial is testing whether or not the two drugs work well together to treat locoregionally recurrent squamous cell carcinoma of the head and neck.
Who is the study for?
Adults with confirmed recurrent squamous cell carcinoma of the head and neck, who can provide tissue samples, have not had certain treatments recently, and are in relatively good health. Women must use contraception and have a negative pregnancy test; men must also agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing a combination of two immunotherapy drugs called Nivolumab (Opdivo™) and Lirilumab as potential treatments for head and neck cancer before and after surgery.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting different organs, infusion-related symptoms, fatigue, liver enzyme changes, blood count variations, kidney function alterations, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of squamous cell carcinoma in the head or neck area.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am eligible for additional surgery to treat my cancer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27.2 months post salvage surgery, up to 28 months total.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27.2 months post salvage surgery, up to 28 months total.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-Year Disease-Free Survival Percentage
Secondary outcome measures
1-Year Overall Survival Percentage
Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score
Median Disease-Free Survival Rate
+1 moreSide 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%
Hypomagnesaemia
19%
Headache
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
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: Nivolumab+LirilumabExperimental Treatment2 Interventions
The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection.
In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle
In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Lirilumab
2017
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,843 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,485 Total Patients Enrolled
Glenn J. Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune condition but am stable, not on high-dose steroids for over 4 weeks.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have been treated with immunotherapy targeting cancer.I have a lung condition not caused by infection.My cancer is a type of squamous cell carcinoma in the head or neck area.I agree to give blood and tissue samples for research.My oropharyngeal cancer's HPV status is known.I can take care of myself but might not be able to do heavy physical work.My kidney function is normal or nearly normal.I am a woman who can still have children, not sterilized, and not in menopause.I will use highly effective contraception during and for 7 months after the trial if I'm sexually active with a woman who can become pregnant.I am eligible for additional surgery to treat my cancer.My organ and bone marrow functions are normal.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from its side effects.I do not have brain metastases.I was cancer-free for more than 8 weeks after my first treatment ended.I have not received a live vaccine in the last 30 days.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Lirilumab
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.
Is Nivolumab a viable treatment option for patients?
"Because Nivolumab is in Phase 2 of clinical trials, there is evidence suggesting it is safe but not yet effective. Our team gave it a rating of 2."
Answered by AI
How many guinea pigs are testing this new medication?
"Unfortunately, this trial is not currently admitting patients. The posting for this study was first made on March 15th, 2018 and was updated as recently as May 23rd, 2022. If you are interested in other trials, there are presently 2758 clinical trials actively admitting patients with carcinoma, squamous cell and 748 studies for Nivolumab actively admitting patients."
Answered by AI
What are the standard uses for Nivolumab?
"Nivolumab, while most often used to treat malignant neoplasms, can also be an effective treatment for various other conditions such as unresectable melanoma and squamous cell carcinoma."
Answered by AI
What other research has been conducted with Nivolumab?
"As of right now, there are 748 different ongoing clinical trials that involve the use of Nivolumab. Out of those, 82 have reached Phase 3 testing. However, these studies are not limited to Basel as 40405 locations across the globe are conducting research on this medication."
Answered by AI
Can patients sign up for this clinical trial at this time?
"Unfortunately, this trial is no longer enrolling patients. The last update on clinicaltrials.gov was from 5/23/2022 and it first posted on 3/15/2018. With that said, there are 3506 other trials currently looking for participants."
Answered by AI
Have there been other scientific investigations like this one before?
"Nivolumab has a long research history, with the first clinical study being performed in 2010. After the initial Phase 1 127-person trial sponsored by Medarex, Nivolumab received approval for use as a drug. As of now, there are 748 live studies involving Nivolumab taking place across 2349 cities and 50 countries."
Answered by AI
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