Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT03247712
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 240mg IV q2wks or 480mg IV q4wks
  • Surgical Resection — PROCEDURE
    Surgical Resection of Tumor
  • Radiation (5 days) — RADIATION
    8Gy x 5 (Mon-Fri) GTV+3mm
  • Radiation (3 days) — RADIATION
    8Gy x 3 (Monday, Wednesday, Friday) GTV+3mm

Study Details

The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.

Key Dates

Start date
Jan 15, 2018
Status verified
Jul 2025
Primary completion
Feb 13, 2020
Completion
Dec 31, 2026

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Cohort 1
    Nivolumab administration (3 doses) and radiation (5 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
  • Experimental: Treatment Cohort 2
    Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
  • Experimental: Treatment Cohort 3
    Radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
  • Experimental: Treatment Cohort 4
    Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Primary Outcome Measure

Number of patients with an Unplanned Delay to Surgery [Safety and Tolerability of Neoadjuvant Treatment] [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97213-

Find similar trials in Portland, OR

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Providence Portland Medical Center· Portland, OR

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