Clinical trial NCT01990859: Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Official title: Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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) - All Treated Participants
timeFrame: Day 1 to 90 Days after the last dose, up to July 2014
measure: Number of Participants Who Died - All Treated Participants
timeFrame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
measure: Number of Participants With Hematology Laboratory Abnormalities
timeFrame: Baseline to 90 days post last dose, up to July 2014
measure: Number of Participants With Liver Function Laboratory Abnormalities
timeFrame: Baseline to 90 days post last dose, up to July 2014
measure: Number of Participants With Renal Laboratory Abnormalities
timeFrame: Baseline to 90 days post last dose, up to July 2014
measure: Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response
timeFrame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
measure: Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response
timeFrame: Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kumamoto-shi
country: Japan
facility: Local Institution
state: Kumamoto
city: Matsumoto-shi
country: Japan
facility: Local Institution
state: Nagano
city: Sunto-gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-shi
country: Japan
facility: Local Institution
state: Yamanashi
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.