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A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03165422
Enrollment
68
Registered
2017-05-24
Start date
2017-03-01
Completion date
2018-12-29
Last updated
2019-10-23

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

Conditions

Melanoma

Brief summary

This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Ono Pharmaceutical Co. Ltd
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients \> 18 years of age or older * Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection * Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Exclusion criteria

* Patients enrolled in any clinical trials at any time * Overlapping use of nivolumab and ipilimumab

Design outcomes

Primary

MeasureTime frame
Incidence of ipilimumab treatment after nivolumab treatmentApproximately 19 months
Incidence of nivolumab treatment after ipilimumab treatmentApproximately 19 months
Duration of nivolumab treatmentApproximately 19 months
Duration of ipilimumab treatmentApproximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatmentApproximately 19 months

Secondary

MeasureTime frameDescription
overall response rate (ORR)Approximately 19 months
severity of treatment-related adverse events (AEs)Approximately 19 monthsseverity of treatment-related adverse events (AEs)/adverse reactions (ARs)
best overall response rate (BORR)Approximately 19 months
overall survival (OS)Approximately 19 months
progression-free survival (PFS)Approximately 19 months
incidence of treatment-related adverse events (AEs)Approximately 19 monthsincidence of treatment-related adverse events (AEs)/adverse reactions (ARs)

Countries

Japan

Outcome results

None listed

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