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Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC

NCT03646461 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-05-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

Ibrutinib 560mg PO daily (Imbruvica)

BTK inhibitor combined with PD-1 inhibitor

DRUG

Cetuximab

Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle

DRUG

Nivolumab

Nivolumab 3mg/kg biweekly 28 day cycle

Sponsors & Collaborators

Principal Investigators

  • Kathryn Gold, MD · University of California San Diego, Moores Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2020-08-15
Completion
2021-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646461 on ClinicalTrials.gov