Clinical trial · Interventional
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma
NCT01990859CI-TRIAL-00021347completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A: Ipilimumab
- description
- Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses
- interventionNames
- Biological: Ipilimumab
Primary outcomes (1)
- measure
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants
- timeFrame
- Day 1 to 90 Days after the last dose, up to May 2014
- description
- AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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: * Active brain metastases * Primary ocular or mucosal melanoma * History of or current active autoimmune disease
References
Publications (1)
- DERIVEDYamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T. Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):997-1004. doi: 10.1007/s00280-015-2873-x. Epub 2015 Sep 26. PMID 26410424