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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.
Must not have
Prior therapy with an EGFR inhibitor in the recurrent or metastatic setting
Active autoimmune disease or other contraindication to PD-1 inhibition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 yrs
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am not able to become pregnant or I have a negative pregnancy test.
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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.
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I am fully active or can carry out light work.
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My cancer's p16 or HPV status is known.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with an EGFR inhibitor for my cancer when it came back or spread.
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I do not have an active autoimmune disease or a condition that prevents me from receiving PD-1 inhibitors.
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I have not had major surgery in the last 4 weeks.
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I haven't had chemotherapy in the last 28 days or immunotherapy in the last 16 weeks.
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I have a history of HIV, or I am currently infected with hepatitis B or C.
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I have a history of interstitial lung disease.
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I have moderate to severe liver problems.
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I understand the study's purpose and risks and can sign the consent form.
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I am willing and able to follow all study requirements.
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I have been treated with BTK, PD-1, or PD-L1 inhibitors before.
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I do not have any severe illnesses or organ problems.
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I have a bleeding disorder or hemophilia.
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I am currently taking warfarin or similar blood thinners.
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I need treatment with a strong medication that affects liver enzymes.
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I have a serious heart condition that is currently causing symptoms.
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My cancer is nasopharyngeal carcinoma.
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I do not have any ongoing infections that aren't being treated.
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I cannot swallow pills or have a condition that affects how my body absorbs nutrients.
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I have no lasting side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 yrs
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 yrs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Efficacy of Combined Therapies using RECIST v1.1
Secondary study objectives
Duration of Response
Overall Survival
Progression Free Survival
+1 more
Other study objectives
Measurement of Biomarkers

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Hyponatremia
19%
Acne
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Pruritus
15%
Fatigue
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypocalcaemia
7%
Dermatitis Acneiform
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%
Mouth hemorrhage
1%
Pneumonia
1%
Electrolyte imbalance
1%
Microcytic anemia
1%
Myocardial infarction
1%
Pneumonitis
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Pulmonary embolism
1%
Respiratory alkalosis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Nivolumab
2015
Completed Phase 3
~4010
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,187 Previous Clinical Trials
1,576,842 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,848 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

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03646461 — Phase 2
Head and Neck Cancers Research Study Groups: Arm A: Ibrutinib + Cetuximab, Arm B: Ibrutinib + Nivolumab
Head and Neck Cancers Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03646461 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646461 — Phase 2
~0 spots leftby Jan 2025
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