Phase 2 Study of Ipilimumab Plus DTIC in Japanese Advanced Melanoma Patients

Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221931

Enrollment

Registered

2012-10-01

Start date

2012-10-01

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 + Dacarbazine INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histologic diagnosis of malignant melanoma -Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma -Life expectancy of at least 16 weeks in this study -Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Exclusion criteria: -Evidence of brain metastases on brain imaging -Primary ocular or mucosal melanoma -History of or current active autoimmune disease

Design outcomes

Primary

Measure	Time frame
To determine survival rate defined as the proportion of subjects who are alive after at least one year of follow up following the first dose of study therapy Survival rate at 1 year will be calculated using the number of patients alive at least one year of follow up following the first dose of study therapy.	—

Secondary

Measure	Time frame
To assess frequency of Grade 3-4 Immune-related Adverse Events (irAEs) irAEs will be measured every 3 weeks in induction phase, every 6 weeks in maintenance to Week 48, and every 12 weeks to Progressive Disease (PD)	—

Outcome results

None listed

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