Clinical trial NCT01681212: Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma
Official title: Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 21
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Surviving at 1 Year
timeFrame: At 1 year from start of study drug
Secondary outcomes:
measure: Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)
timeFrame: First dose to 90 days following last dose of study drug
measure: 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
timeFrame: 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.
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, 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.