Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Phase 2 Study of Ipilimumab in Japanese Subjects with Unresectable or Metastatic Melanoma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222335

Enrollment

Registered

2013-12-19

Start date

2013-12-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Melanoma

Interventions

investigational material(s) Generic name etc : Ipilimumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed diagnosis of malignant melanoma Previously-treated or untreated unresectable Stage III or Stage IV melanoma Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Exclusion criteria: Active brain metastases Primary ocular or mucosal melanoma History of or current active autoimmune disease

Design outcomes

Primary

Measure	Time frame
Safety Safety of Ipilimumab monotherapy based on serious and non-serious adverse events, laboratory evaluations, dose exposure and modifications. In addition, abnormal vital signs and physical examination findings are also included	—

Secondary

Measure	Time frame
Best overall response rate (BORR) Best Overall Response Rate, defined as the total number of subjects whose Best Overall Response is Complete Response (CR) or Partial Response (PR) divided by the total number of treated subjects.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026