Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03646461 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by University of California, San Diego.

Active
Registry status
Phase 2
Development phase
5
Enrollment target
1
Study location

NCT03646461: Active Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by University of California, San Diego.

NCT03646461 is a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 5 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03646461, a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, is active but no longer recruiting, sponsored by University of California, San Diego.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
5 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

The primary endpoint is the clinical efficacy of each combinatorial treatment regimen as defined by the best overall response rate (proportion of patients with a partial or complete response in tumor burden) using RECIST v1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Conditions Studied

Head and Neck Cancer Squamous Cell Carcinoma of the Head and Neck

Interventions

  • DRUG Nivolumab
  • DRUG Cetuximab
  • DRUG Ibrutinib 560mg PO daily (Imbruvica)

Study Locations (1)

California

  • UCSD Moores Cancer Center - La Jolla

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-10-17
Est. Completion 2025-12-30
Phase Phase 2
University of California, San Diego

775 total trials

What the registry record for NCT03646461 still lists

NCT03646461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.

NCT03646461 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT03646461 about?

NCT03646461 is a clinical study titled "Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC". 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

What is the current status of trial NCT03646461?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-10-17. Estimated completion is 2025-12-30.

What conditions does trial NCT03646461 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck.

What interventions are being tested in trial NCT03646461?

The interventions under investigation include: Nivolumab (DRUG), Cetuximab (DRUG), Ibrutinib 560mg PO daily (Imbruvica) (DRUG).

Who is sponsoring clinical trial NCT03646461?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03646461 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03646461's enrollment target sits among peer trials

5 244th of 250 higher than 6 of 250 other Head and Neck Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT03646461, the US trial registry maintained by the National Library of Medicine. NCT03646461 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.