Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

NCT ID: NCT01165216

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-06-30

Brief Summary

The primary purpose of this study was to establish the recommended dose of ipilimumab administered in combination with paclitaxel and carboplatin in Japanese patients with nonsmall-cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Study Design

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

Study Groups

Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin

Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).

Group Type: EXPERIMENTAL

Ipilimumab, 3 mg

Intervention Type: DRUG

Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles

Paclitaxel

Intervention Type: DRUG

IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles

Carboplatin

Intervention Type: DRUG

IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin

Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).

Group Type: EXPERIMENTAL

Ipilimumab, 10 mg

Intervention Type: DRUG

IV injection, administered every 3 weeks for up to 6 cycles

Paclitaxel

Intervention Type: DRUG

IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles

Carboplatin

Intervention Type: DRUG

IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Interventions

Ipilimumab, 3 mg

Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles

Intervention Type: DRUG

Ipilimumab, 10 mg

IV injection, administered every 3 weeks for up to 6 cycles

Intervention Type: DRUG

Paclitaxel

IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles

Intervention Type: DRUG

Carboplatin

IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Intervention Type: DRUG

Other Intervention Names

BMS-734016

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically documented nonsmall-cell lung cancer (NSCLC) presenting as stage IIIB disease without indications for definitive radiotherapy, stage IV disease, or recurrent disease following radiation therapy or surgical resection
• No prior chemotherapy, hormonal therapy, immunotherapy, or targeted-therapy-containing regimens for the treatment of NSCLC
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group performance score of 0-1
• Adequate bone marrow function
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count ≥1,500/mm^3
• Platelet count ≥100,000/mm^3
• Adequate liver function
• Total bilirubin level ≤2.0*the upper limit of normal (ULN)
• Asparate aminotransferase level ≤2.5*ULN
• Alanine aminotransferase level ≤2.5*ULN
• Adequate renal function
• Calculated creatinine clearance based on Cockcroft and Gault formula ≥50 mL/min.

Exclusion Criteria

• Symptomatic central nervous system (CNS) metastasis or active CNS metastasis requiring medication
• Malignant body cavity fluid (eg, pleural effusion, cardiac effusion, ascites) that recurred despite appropriate supportive care
• Prior radiation of ≥30% of major bone-marrow containing areas (pelvis, lumbar spine)
• Documented history of severe autoimmune or immune-mediated symptomatic disease that required prolonged (longer than 2 months) systemic immunosuppressant treatment
• Documented history of motor neuropathy considered of autoimmune origin (eg, Guillain Barré syndrome)
• Any concurrent malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma of the mucous membrane of the gastrointestinal tract, or superficial bladder cancer treated with systemic therapy
• ≥Grade 2 diarrhea
• History of or concurrent disease of gastrointestinal tract perforations
• ≥Grade 2 peripheral neuropathy (motor or sensory)
• Uncontrolled intercurrent illness including infection requiring systemic therapy, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer, and cardiac arrhythmia requiring medication
• Positive finding for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C virus antibody.

• 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

Chuo-ku, Tokyo, Japan

Countries

Japan

References

Horinouchi H, Yamamoto N, Fujiwara Y, Sekine I, Nokihara H, Kubota K, Kanda S, Yagishita S, Wakui H, Kitazono S, Mizugaki H, Tokudome T, Tamura T. Phase I study of ipilimumab in phased combination with paclitaxel and carboplatin in Japanese patients with non-small-cell lung cancer. Invest New Drugs. 2015 Aug;33(4):881-9. doi: 10.1007/s10637-015-0243-5. Epub 2015 May 1.

Reference Type: DERIVED

PMID: 25924991 (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

CA184-113

Identifier Type: -

Identifier Source: org_study_id