Ibrutinib + Nivolumab/Cetuximab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Kathryn Gold, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is an open-label, randomized, phase II trial to test the efficacy of Ibrutinib in combination with either Nivolumab or Cetuximab in the treatment of recurrent and/or metastatic head an neck squamous cell carcinoma

Eligibility Criteria

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.

Inclusion Criteria

Ability and willingness to provide written informed consent

My liver and kidneys are working well.

Presence of measurable tumor lesions per RECIST criteria v1.1 by investigator review

Exclusion Criteria

Lactating or pregnant

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.

Participant Groups

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.

Group I: Arm B: Ibrutinib + Nivolumab Experimental Treatment 2 Interventions

Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle

Group II: Arm A: Ibrutinib + Cetuximab Experimental Treatment 2 Interventions

Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

• Locally or regionally advanced squamous cell carcinoma of the head and neck
• Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
• BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for:

• Squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSD Moores Cancer Center La Jolla, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

Pharmacyclics LLC. Industry Sponsor

References