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

NCT01681212 | Completed Phase 2 Results

• 1 other identifier: CA184-202
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Surviving at 1 Year

  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 Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason.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.

  At 1 year from start of study drug

Secondary Outcomes (2)

• Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)

  First dose to 90 days following last dose of study drug

• Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs

  First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug.

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: Ipilimumab; Drug: Dacarbazine

Interventions

Ipilimumab DRUG

Also known as: BMS-734016

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

Dacarbazine DRUG

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

Local Institution

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution

Kumamoto, Kumamoto, 8608556, Japan

Location

Local Institution

Matsumoto-shi, Nagano, 3908621, Japan

Location

Local Institution

Sunto-gun, Shizuoka, 4118777, Japan

Location

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution

Chuo-shi, Yamanashi, 4093898, Japan

Location

Related Publications (1)

• 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.

  PMID: 26407818 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was discontinued due to severe liver toxicity.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 11, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-06

Locations

JP (6)