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

NCT03829722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-22

Study results available
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Summary

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.

Conditions

  • Oropharynx Squamous Cell Carcinoma

Interventions

DRUG

Nivolumab

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.

DRUG

Carboplatin

Given IV once per week during radiation therapy (AUC=1).

DRUG

Paclitaxel

Given IV once per week during radiation therapy (30mg/m\^2)

RADIATION

Radiation Therapy

Given 5 days/week for a total of 35 doses (70 gray total).

Sponsors & Collaborators

Principal Investigators

  • Michelle Mierzwa, M.D. · University of Michigan Rogel 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
2019-09-05
Primary Completion
2024-06-11
Completion
2024-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03829722 on ClinicalTrials.gov