Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

NCT ID: NCT01681212

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-05-31

Brief Summary

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

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2

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.

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Dacarbazine

Intervention Type: DRUG

Interventions

Ipilimumab

Intervention Type: DRUG

Dacarbazine

Intervention Type: DRUG

Other Intervention Names

BMS-734016

Eligibility Criteria

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)

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Kumamoto, Kumamoto, Japan

Local Institution

Matsumoto-shi, Nagano, Japan

Local Institution

Sunto-gun, Shizuoka, Japan

Local Institution

Chuo-ku, Tokyo, Japan

Local Institution

Chuo-shi, Yamanashi, Japan

Countries

Japan

References

Yamazaki 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.

Reference Type: DERIVED

PMID: 26407818 (View on PubMed)

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA184-202

Identifier Type: -

Identifier Source: org_study_id