Interferon Toxicities in Melanoma Treatment

Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma

NCT02794636•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
•Patients with a melanoma diagnosis based on two medical claims prior to the index date
•Patients with a procedure code for melanoma-related lymph node dissection before the index date
•Patients ≥ 18 years of age on or before the index date
•Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria

•Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
•Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
•Patients who received systemic chemotherapy during the pre- or post-index period

Key Dates

Start Date

May 1, 2014

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

June 9, 2016

Enrollment

436

ACTUAL participants

Conditions

Stage III Melanoma

Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting

NCT05079113

Stage III MelanomaStage IV Cutaneous Melanoma

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TERMINATEDPHASE1/PHASE2

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

NCT00945269

Recurrent MelanomaStage III Melanoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interferon Toxicities in Melanoma Treatment

Inclusion Criteria

Exclusion Criteria

Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma