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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Paclitaxel
Drug: Carboplatin
Drug: Ipilimumab, 3 mg
Drug: Ipilimumab, 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01165216
CA184-113

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin
Experimental group
Description:
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).
Treatment:
Drug: Ipilimumab, 3 mg
Drug: Paclitaxel
Drug: Carboplatin
Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Experimental group
Description:
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).
Treatment:
Drug: Ipilimumab, 10 mg
Drug: Paclitaxel
Drug: Carboplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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