Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03829722
Phase
PHASE2
Status
Completed

Conditions

  • Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
  • Carboplatin — DRUG
    Given IV once per week during radiation therapy (AUC=1).
  • Paclitaxel — DRUG
    Given IV once per week during radiation therapy (30mg/m\^2)
  • Radiation Therapy — RADIATION
    Given 5 days/week for a total of 35 doses (70 gray total).

Study Details

The purpose of this study is to find out if the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with high risk HPV-related squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate). Fractionated means the radiation will be administered in fragments or parts across multiple days.

Key Dates

Start date
Sep 5, 2019
Status verified
Jan 2026
Primary completion
Jun 11, 2024
Completion
Jun 11, 2024

Study Design

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

Arms

  • Experimental: Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
    Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 2 years after completion of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-

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University of Michigan Rogel Cancer Center· Ann Arbor, MI

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