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

NCT03652233 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-06-20

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Nivolumab

Given by vein every 14 days for up to 12 months

DRUG

Afatinib

Taken by mouth daily for up to 12 months

Sponsors & Collaborators

Principal Investigators

  • Mike Gibson, MD, PhD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-02
Primary Completion
2021-11-30
Completion
2022-11-30
FDA Drug
Yes

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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 NCT03652233 on ClinicalTrials.gov