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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 27.2 months post salvage surgery, up to 28 months total.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27.2 months post salvage surgery, up to 28 months total. for reporting.

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 more

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%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
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

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
1,080 Previous Clinical Trials
340,901 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,803 Total Patients Enrolled
Glenn J. Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03341936 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Nivolumab+Lirilumab
Squamous Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03341936 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03341936 — Phase 2
~4 spots leftby Jun 2025
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