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Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT02741570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 947

Last updated 2023-09-21

Study results available
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Summary

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

Conditions

Interventions

BIOLOGICAL

Nivolumab

BIOLOGICAL

Ipilimumab

DRUG

Cetuximab/Erbitux

DRUG

Cisplatin/Platinol

DRUG

Carboplatin/Paraplatin

DRUG

Fluorouracil/Adrucil

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-05
Primary Completion
2021-05-10
Completion
2022-09-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

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 NCT02741570 on ClinicalTrials.gov