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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT03646461
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 17, 2018
Status verified
Apr 2026
Primary completion
Aug 15, 2020
Completion
May 13, 2021

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Ibrutinib + Cetuximab
    Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
  • Experimental: Arm B: Ibrutinib + Nivolumab
    Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle

Primary Outcome Measure

Clinical Efficacy of Combined Therapies Using RECIST v1.1 [ Time Frame: Up to 22 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093-

Related coverage on Hipa.ai

Find similar trials in La Jolla, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UCSD Moores Cancer Center· La Jolla, CA

Related Studies