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NCT03663946 Clinical Trial

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

Renal Cell Carcinoma Clinical Trial

Official title:
Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663946
Other study ID # CA209-8MK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2018
Est. completion date May 30, 2020

Study information
Verified date February 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date May 30, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Japan Local Institution Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of immune-related AE's Approximately 13 weeks
Primary Incidence of immune related SAE's Approximately 13 weeks
Secondary Incidence of treatment for immune-related adverse reactions Approximately 13 weeks
Secondary Incidence of unknown AE's Approximately 13 weeks
Secondary Incidence of unknown SAE's Approximately 13 weeks
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