Clinical trial · Interventional
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma
NCT01681212CI-TRIAL-00018241completedPhase 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 determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2
- description
- During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m\^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
- interventionNames
- Drug: Ipilimumab
- Drug: Dacarbazine
Primary outcomes (1)
- measure
- Percentage of Participants Surviving at 1 Year
- timeFrame
- At 1 year from start of study drug
- description
- Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Key inclusion criteria: * Japanese patients with histologic diagnosis of malignant melanoma * Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma * Prior adjuvant melanoma therapy permitted * Eastern Cooperative Oncology Group performance status of 0 or 1 * Life expectancy of at least 16 weeks in this study * Adequate bone marrow and renal and hepatic function, specifically: * white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5\*upper limit of normal (ULN), aspartate transaminase/alanine transaminase level \<2.5\*ULN for patients without liver metastasis and \<5\*ULN for patients with liver metastasis, total bilirubin level \<1.5\*ULN (for those with Gilbert's Syndrome, lower than 3.0 mg/dL) Key exclusion criteria: * Evidence of brain metastases on brain imaging * Active brain metastases with symptoms or requiring corticosteroid treatment; patients with any other malignancy from which they have been disease-free for fewer than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * Primary ocular or mucosal melanoma * History of or current active autoimmune disease * History or concurrent disease of gastrointestinal perforations * HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection, based on testing performed during the screening period of this study * Prior or concomitant therapy with any anticancer agent for melanoma, or other investigational anticancer therapies * Prior adjuvant therapy \<4 weeks prior to the start of study drug administration * Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy * Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy drugs * Treatment with other investigational products within 4 weeks prior to initial treatment of study drug
References
Publications (1)
- DERIVEDYamazaki N, Uhara H, Fukushima S, Uchi H, Shibagaki N, Kiyohara Y, Tsutsumida A, Namikawa K, Okuyama R, Otsuka Y, Tokudome T. Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):969-75. doi: 10.1007/s00280-015-2870-0. Epub 2015 Sep 25. PMID 26407818