A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-13

Study Completion Date

2021-10-18

Brief Summary

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The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

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Detailed Description

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This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab

Nivolumab

Intervention Type BIOLOGICAL

Participants in this study are being treated with nivolumab for SCCHN

Interventions

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Nivolumab

Participants in this study are being treated with nivolumab for SCCHN

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo®, BMS-936558

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
* Age ≥18 years at time of nivolumab treatment initiation
* Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
* Charts/records include treatment start date of nivolumab
* Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion

Exclusion Criteria

* Currently enrolled in an interventional clinical trial for their SCCHN
* Received systemic treatment for any other primary cancer within 6 months of study enrolment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No