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Nivolumab or Nivolumab Plus C...

Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

Last Updated: 2021-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-10-14

Brief Summary

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This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Cohort 1

Group Type EXPERIMENTAL