A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03663946
Collaborator
(none)
81
1
20.4
4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
81 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)
Actual Study Start Date
:
Sep 18, 2018
Actual Primary Completion Date
:
May 30, 2020
Actual Study Completion Date
:
May 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients taking combination therapy with Yervoy and Opdivo Medical records will be reviewed for safety and treatments for specific ADR |
Other: Non-Interventional
Non-Interventional
|
Outcome Measures
Primary Outcome Measures
- Incidence of immune-related AE's [Approximately 13 weeks]
- Incidence of immune related SAE's [Approximately 13 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Tokyo | Japan | 170-8630 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03663946
Other Study ID Numbers:
- CA209-8MK
First Posted:
Sep 10, 2018
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: