Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

NCT01990859 | Completed Phase 2 Results

• 1 other identifier: CA184-396
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Day 1 to 90 Days after the last dose, up to May 2014

Secondary Outcomes (7)

• Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants

  Day 1 to 90 Days after the last dose, up to July 2014

• Number of Participants Who Died - All Treated Participants

  Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)

• Number of Participants With Hematology Laboratory Abnormalities

  Baseline to 90 days post last dose, up to July 2014

• Number of Participants With Liver Function Laboratory Abnormalities

  Baseline to 90 days post last dose, up to July 2014

• Number of Participants With Renal Laboratory Abnormalities

  Baseline to 90 days post last dose, up to July 2014

Study Arms (1)

Arm A: Ipilimumab

EXPERIMENTAL

Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses

Biological: Ipilimumab

Interventions

Ipilimumab BIOLOGICAL

Also known as: BMS-734016

Arm A: Ipilimumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Active brain metastases
• Primary ocular or mucosal melanoma
• History of or current active autoimmune disease

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, 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 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

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

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: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: May 21, 2015

Record last verified: 2016-02

Locations

JP (6)