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OpenTrials
Completed

NCT Number: NCT03663946

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

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

Completed

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tokyo, 170-8630, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Incidence of immune-related AE's

    Time frame: Approximately 13 weeks

  2. Incidence of immune related SAE's

    Time frame: Approximately 13 weeks

Secondary outcomes

  1. Incidence of treatment for immune-related adverse reactions

    Time frame: Approximately 13 weeks

  2. Incidence of unknown AE's

    Time frame: Approximately 13 weeks

  3. Incidence of unknown SAE's

    Time frame: Approximately 13 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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