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Monoclonal Antibodies
Ibrutinib + Nivolumab/Cetuximab for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Kathryn Gold, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects who are of non-reproductive potential or have a negative serum pregnancy test upon study entry
Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy. P16 or HPV status must be known on all patients with oropharyngeal primaries or unknown primaries.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 yrs
Awards & highlights
Study Summary
This trial is testing whether ibrutinib, in combination with either nivolumab or cetuximab, is effective in treating recurrent and/or metastatic head and neck squamous cell carcinoma.
Who is the study for?
Adults with recurrent or metastatic head and neck squamous cell carcinoma not suitable for curative treatment. Participants must have known P16/HPV status, measurable tumor lesions, a life expectancy over 12 weeks, adequate organ function, and agree to use effective birth control. Exclusions include active central nervous system metastases, recent immunosuppressant therapy or live vaccines, prior specific cancer treatments, certain bleeding disorders or infections.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Ibrutinib in combination with either Nivolumab or Cetuximab in treating advanced head and neck cancers. It's an open-label (patients know what they're getting), randomized (assigned by chance), phase II study to see which combination works better.See study design
What are the potential side effects?
Possible side effects may include immune-related reactions due to Nivolumab such as inflammation of organs; skin rashes from Cetuximab; bleeding risks from Ibrutinib; fatigue; digestive issues like diarrhea; liver enzyme changes indicating potential liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not able to become pregnant or I have a negative pregnancy test.
Select...
My cancer is a type that started in my head or neck and cannot be cured with surgery or radiation. I know if it's related to HPV.
Select...
I am fully active or can carry out light work.
Select...
My cancer's p16 or HPV status is known.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 yrs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 yrs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Efficacy of Combined Therapies using RECIST v1.1
Secondary outcome measures
Duration of Response
Overall Survival
Progression Free Survival
+1 moreOther outcome measures
Measurement of Biomarkers
Side effects data
From 2012 Phase 3 trial • 73 Patients • NCT0117795643%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Cough
9%
Dizziness
9%
White Blood Cell Count Decreased
7%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Hypochloremia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Dyspnoea
6%
Neck pain
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Respiratory alkalosis
1%
Microcytic anemia
1%
Myocardial infarction
1%
Pneumonia
1%
Pneumonitis
1%
Electrolyte imbalance
1%
Mouth hemorrhage
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Ibrutinib + NivolumabExperimental Treatment2 Interventions
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Group II: Arm A: Ibrutinib + CetuximabExperimental Treatment2 Interventions
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,630 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,815 Total Patients Enrolled
Kathryn Gold, MD4.735 ReviewsPrincipal Investigator - University of California San Diego, Moores Cancer Center
Doctors Community Hospital
Medical School - St. George's University School of Medicine, Doctor of Medicine
Saint Joseph Mercy Oakland, Residency in Internal Medicine
5Patient Review
Perfect
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an EGFR inhibitor for my cancer when it came back or spread.I do not have an active autoimmune disease or a condition that prevents me from receiving PD-1 inhibitors.I have not had major surgery in the last 4 weeks.I haven't had chemotherapy in the last 28 days or immunotherapy in the last 16 weeks.I have a history of HIV, or I am currently infected with hepatitis B or C.I have a history of interstitial lung disease.I have moderate to severe liver problems.I understand the study's purpose and risks and can sign the consent form.My liver and kidneys are working well.I am willing and able to follow all study requirements.I have been treated with BTK, PD-1, or PD-L1 inhibitors before.I have had cancer before, but it fits the exceptions.I have not received any live vaccines in the last 4 weeks.I do not have any severe illnesses or organ problems.I have a bleeding disorder or hemophilia.My blood counts are stable without transfusions or most growth supports for a week.I am not able to become pregnant or I have a negative pregnancy test.I am currently taking warfarin or similar blood thinners.I need treatment with a strong medication that affects liver enzymes.My cancer is a type that started in my head or neck and cannot be cured with surgery or radiation. I know if it's related to HPV.I am fully active or can carry out light work.I agree to use effective birth control and a barrier method during and after treatment.I am 18 years old or older.I have a serious heart condition that is currently causing symptoms.I have stable brain metastases.My cancer is nasopharyngeal carcinoma.I do not have any ongoing infections that aren't being treated.My cancer's p16 or HPV status is known.I cannot swallow pills or have a condition that affects how my body absorbs nutrients.I haven't taken immunosuppressants in the last 28 days.I finished treatment for an infection less than 14 days ago.I have not had a stroke or brain bleed in the last 6 months.I have no lasting side effects from previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Ibrutinib + Cetuximab
- Group 2: Arm B: Ibrutinib + Nivolumab
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.
What maladies does Cetuximab typically address?
"Cetuximab is most frequently utilized to address inoperable cases of melanoma, as well as squamous cell carcinoma with a high risk of recurrence and patients who are unable to tolerate irinotecan."
Answered by AI
What prior research has been conducted concerning the viability of Cetuximab for clinical use?
"A total of 980 clinical trials studying Cetuximab are currently in operation, 133 of which are at the stage 3. Despite a majority being conducted from Pittsburgh, Pennsylvania there are 52625 different locations running trails for this medication."
Answered by AI
Are there any opportunities for patients to participate in this medical trial at the present?
"The clinicaltrial.gov platform indicates that this medical study is not presently recruiting patients, despite being created on October 17th 2018 and edited January 12th 2022. Fortunately, there are an abundance of alternative trials currently accepting participants - 3882 to be exact."
Answered by AI
Has Cetuximab been sanctioned by the Food and Drug Administration?
"Cetuximab's safety was graded as a 2 on our team's rating system, since the drug is currently in Phase 2 trials and has only yielded evidence of its security."
Answered by AI
What is the aggregate of participants engaged in this experiment?
"Recruitment for this trial has concluded. It was first posted on October 17, 2018 and last edited January 12, 2022. If you are still looking to participate in a study, there are currently 2902 trials that require participants with oral squamous cell carcinoma and another 980 studies actively searching for patients taking Cetuximab medication."
Answered by AI
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