NCT03663946

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

September 7, 2018

Last Update Submit

February 9, 2022

Conditions

Renal Cell CarcinomaKidney Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of immune-related AE's

    Approximately 13 weeks

  • Incidence of immune related SAE's

    Approximately 13 weeks

Secondary Outcomes (3)

  • 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

Study Arms (1)

Patients taking combination therapy with Yervoy and Opdivo

Medical records will be reviewed for safety and treatments for specific ADR

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Patients taking combination therapy with Yervoy and Opdivo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Tokyo, 170-8630, Japan

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 10, 2018

Study Start

September 18, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

JP(1)