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Checkpoint Inhibitor
Nivolumab +/- Ipilimumab for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Jonathan Schoenfeld, 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
Only patients 18 years and older are eligible. There is no upper age limit but the patients must be able to medically tolerate the regimen. Adverse event data are currently unavailable on the use immune checkpoint blockade for participants < 18 years of age, and thus children are excluded from this study
Participants must have normal organ and marrow function as defined below: Laboratory parameters: WBC ≥ 2000/uL, Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin (Hgb) ≥ 9 g/dL; Hgb-A1C ≤ 7.5%; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); Bilirubin ≤ 2.5 × ULN (≤ 4 × ULN for subjects with Gilbert's disease); Alkaline phosphatase ≤ 2.5 × ULN; Creatinine ≤ 1.5 × ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying nivolumab and ipilimumab to see how well they work in treating patients with squamous cell carcinoma of the oral cavity.
Who is the study for?
Adults with squamous cell carcinoma of the oral cavity, who are fit for surgery and have not received certain cancer treatments or have active infections. Participants must be able to tolerate anesthesia, have no history of severe allergies to trial drugs, and women of childbearing age must use effective contraception.Check my eligibility
What is being tested?
The study is testing nivolumab alone or combined with ipilimumab against standard surgical care in treating oral cavity squamous cell carcinoma. It aims to see if these drugs can improve outcomes before patients undergo surgery.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect organs, skin rashes, hormone gland problems (like thyroid dysfunction), fatigue, and infusion-related reactions. There may also be risks associated with combining these drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and can medically handle the treatment.
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My blood tests show normal organ function and I don't have severe anemia or diabetes.
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I can carry out all my self-care but cannot do heavy physical work.
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My oral cancer is confirmed and larger than 2 cm or has spread to my lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With a Volumetric Response Rate to Treatment
Safety and Tolerability of Protocol Treatment
Secondary outcome measures
Participant One Year Progression-Free Survival Percentage
Participant Overall Survival Percentage
Percentage of Participants Demonstrating Objective Response Using RECIST Criteria
+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%
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
2Treatment groups
Experimental Treatment
Group I: Nivolumab With IpilimumabExperimental Treatment3 Interventions
Nivolumab to be delivered at a pre-determine dose for two weeks
Ipilimumab to be delivered at a pre-determine dose for one week
Blood Sample Collected
Standard of Care Surgery
Group II: NivolumabExperimental Treatment2 Interventions
Nivolumab to be delivered at a pre-determine dose for two weeks
Blood Sample Collected
Standard of Care Surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,842 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,484 Total Patients Enrolled
Jonathan Schoenfeld, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction to any kind of antibody treatment in the past.I have not received a live vaccine in the last 28 days.I am 18 or older and can medically handle the treatment.I have had chemotherapy in the past 2 years.I have lung inflammation not caused by infection, treated with steroids.I am positive for HIV, Hepatitis B, or Hepatitis C.I am not receiving any other cancer treatments while in this study.I haven't taken high-dose steroids or immunosuppressants within the last 14 days.You have had an allergic reaction to any of the ingredients in the study drug.I haven't needed immune system treatment for an autoimmune disease in the last 2 years, except for conditions like vitiligo, type 1 diabetes, thyroid issues needing only hormone replacement, or psoriasis not needing systemic treatment.My blood tests show normal organ function and I don't have severe anemia or diabetes.I am eligible for surgery and can undergo general anesthesia without serious risks.I will use highly effective contraception during and after the treatment if I am sexually active with a woman who can become pregnant.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I have previously received immunotherapy targeting PD-1 or CTLA-4.I have had radiation therapy to my head or neck.I can avoid pregnancy during and after the trial as required.I can carry out all my self-care but cannot do heavy physical work.I have been cancer-free for 2 years from a previous cancer, or had certain skin/cervical cancers treated recently.My cancer has spread to areas below my collarbone or to my bones, brain, or spinal canal.My oral cancer is confirmed and larger than 2 cm or has spread to my lymph nodes.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants included in this experiment?
"At this time, no further recruitment is being sought for the study which was first made available on November 1st 2016 and last edited on February 22nd 2022. However, there are currently 1024 clinical trials involving head neoplasms actively recruiting patients as well as 765 studies utilizing Nivolumab in search of participants."
Answered by AI
What outcome is the research team hoping to realize with this experiment?
"The primary measure of efficacy evaluated in this trial is the safety and tolerability of protocol treatment, which will be assessed at time of surgery. Additionally, there are secondary objectives to evaluate participants' pathological response using a quantitative grading scheme (PTR0-2), objective response according to RECIST criteria, and overall survival percentages."
Answered by AI
Are fresh volunteers still enrolling in this clinical investigation?
"According to information published on clinicaltrials.gov, this medical research is not actively recruiting volunteers. The trial was initially posted in November 2016 and recently updated in February 2022; however, 1789 other studies are currently seeking participants right now."
Answered by AI
What other research initiatives have been conducted utilizing Nivolumab?
"Currently, there are 765 active clinical trials being conducted on Nivolumab; of those, 86 have progressed to the third phase. Albeit most studies for this drug occur in Pittsburgh, Pennsylvania, an expansive 42707 sites worldwide are running related medical research."
Answered by AI
How might Nivolumab be impacting patients' safety?
"Due to the Phase 2 nature of this trial, Nivolumab has been given a safety rating of two as there is evidence demonstrating its protection but not yet any information on effectiveness."
Answered by AI
What has been demonstrated to be the primary purpose of utilizing Nivolumab?
"Generally, nivolumab is prescribed to patients who have previously had anti-angiogenic therapy. However, it can also be taken to treat more severe conditions such as malignant neoplasms and unresectable melanoma or squamous cell carcinomas."
Answered by AI
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