Afatinib and Nivolumab as Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03652233
Phase
PHASE1
Status
Withdrawn

Conditions

  • Metastatic Squamous Cell Carcinoma of the Head or Neck
  • Recurrent Squamous Cell Carcinoma of the Head or Neck
  • Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Given by vein every 14 days for up to 12 months
  • Afatinib — DRUG
    Taken by mouth daily for up to 12 months

Study Details

This phase I/Ib trial will assess the dose, safety and side effects of the combination of the cancer drugs afatinib (GILOTRIF®) and nivolumab (OPDIVO®) and to assess the anti-cancer effects of this combination of drugs when used to treat patients with advanced head and neck cancers that did not respond to previous treatments.

Key Dates

Start date
Nov 2, 2018
Status verified
Jun 2019
Primary completion
Nov 30, 2021
Completion
Nov 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib and Nivolumab

Primary Outcome Measure

Maximum tolerated dose (phase I) [ Time Frame: Up to 42 days ]

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