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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03663946

Enrollment

Registered

2018-09-10

Start date

2018-09-18

Completion date

2020-05-30

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Renal Cell Carcinoma

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

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Incidence of immune-related AE's	Approximately 13 weeks
Incidence of immune related SAE's	Approximately 13 weeks

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026