A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread

Completed

• Conditions: Kidney Cancer; Renal Cell Carcinoma
• Interventions: Other: Non-Interventional

• Registration Number: NCT03663946
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Study Start: 2018-09-18
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS

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Exclusion Criteria

• Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients taking combination therapy with Yervoy and Opdivo	Non-Interventional	Medical records will be reviewed for safety and treatments for specific ADR

Primary Outcome Measures

Name	Time	Method
Incidence of immune-related AE's	Approximately 13 weeks
Incidence of immune related SAE's	Approximately 13 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of unknown SAE's	Approximately 13 weeks
Incidence of treatment for immune-related adverse reactions	Approximately 13 weeks
Incidence of unknown AE's	Approximately 13 weeks

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tokyo, Japan