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Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer

NCT02764593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-29

No results posted yet for this study

Summary

This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

DRUG

Nivolumab

Anti-PD-1 targeted immunotherapy

DRUG

Cisplatin

Anti-cancer alkylating agent

DRUG

Cetuximab

Epidermal Growth Factor Receptor (EGFR) antagonist

RADIATION

IMRT

High-precision radiotherapy

Sponsors & Collaborators

Principal Investigators

  • Maura Gillison, MD, PhD · RTOG Foundation

  • Robert Ferris, MD, PhD · RTOG Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-09-25
Completion
2022-02-21

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 NCT02764593 on ClinicalTrials.gov