이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

2018년 6월 18일 업데이트: Bristol-Myers Squibb

A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

334

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Bochum, 독일, 44791
        • Local Institution
      • Coswig, 독일, 01640
        • Local Institution
      • Ebensfeld, 독일, 96250
        • Local Institution
      • Grosshansdorf, 독일, 22927
        • Local Institution
      • Halle (Saale), 독일, 06120
        • Local Institution
      • Hamburg, 독일, 21075
        • Local Institution
      • Koeln, 독일, 51109
        • Local Institution
      • Leipzig, 독일, 04103
        • Local Institution
      • Mainz, 독일, 55131
        • Local Institution
      • Muenchen, 독일, 81675
        • Local Institution
  • 러시아 연방
      • Arkhangelsk, 러시아 연방, 163045
        • Local Institution
      • Chelyabinsk, 러시아 연방, 454087
        • Local Institution
      • Ivanovo, 러시아 연방, 153013
        • Local Institution
      • Moscow, 러시아 연방, 115478
        • Local Institution
      • Moscow, 러시아 연방, 105077
        • Local Institution
      • Moscow, 러시아 연방, 125284
        • Local Institution
      • Pyatigorsk, 러시아 연방, 357502
        • Local Institution
      • Saint-Petersburg, 러시아 연방, 190005
        • Local Institution
      • Sochi, 러시아 연방, 354057
        • Local Institution
      • St. Petersburg, 러시아 연방, 197022
        • Local Institution
      • St. Petersburg, 러시아 연방, 198255
        • Local Institution
      • St. Petersburg, 러시아 연방, 194044
        • Local Institution
      • St. Petersburg, 러시아 연방, 194291
        • Local Institution
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35235
        • Birmingham Hematology & Oncology Assoc. Llc
    • Arizona
      • Scottsdale, Arizona, 미국, 85259
        • Mayo Clinic
      • Tucson, Arizona, 미국, 85715
        • Acrc/Arizona Clinical Research Center, Inc.
    • California
      • Corona, California, 미국, 92879
        • Compassionate Cancer Care Medical Group
      • Fountain Valley, California, 미국, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Los Angeles, California, 미국, 90025
        • The Angeles Clinic & Research Institute, Inc
      • Montebello, California, 미국, 90640
        • Oncology Care Medical Associates
      • Riverside, California, 미국, 92501
        • Compassionate Cancer Care Medical Group
      • San Diego, California, 미국, 92123
        • Sharp Clinical Oncology Research
    • Florida
      • Orlando, Florida, 미국, 32806
        • M D Anderson Cancer Center- Orlando
    • Georgia
      • Atlanta, Georgia, 미국, 30341
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • University of Chicago Medical Center
      • Park Ridge, Illinois, 미국, 60068
        • Local Institution
    • Kentucky
      • Hazard, Kentucky, 미국, 41701
        • Kentucky Cancer Clinic
    • Maryland
      • Hagerstown, Maryland, 미국, 21740
        • The John R. Marsh Cancer Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • The Cancer Center
    • Nevada
      • Las Vegas, Nevada, 미국, 89135
        • Nevada Cancer Institute
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, 미국, 10017
        • Local Institution
    • North Carolina
      • Concord, North Carolina, 미국, 28025
        • Cmc-Northeast/ Northeast Oncology Associates
    • Ohio
      • Canton, Ohio, 미국, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, 미국, 43235
        • Hematology Oncology Consultants, Inc
    • Pennsylvania
      • Langhorne, Pennsylvania, 미국, 19047
        • St. Mary Medical Center
      • Sayre, Pennsylvania, 미국, 18840
        • Guthrie Clinical Research
    • South Carolina
      • Sumter, South Carolina, 미국, 29150
        • Santee Hematology/Oncology
    • Texas
      • Lubbock, Texas, 미국, 79415
        • Southwest Cancer Treatment And Research Center
  • 우크라이나
      • Dnipropetrovsk, 우크라이나, 49102
        • Local Institution
      • Donetsk, 우크라이나, 83092
        • Local Institution
      • Kharkov, 우크라이나, 46023
        • Local Institution
      • Lviv, 우크라이나, 79031
        • Local Institution
      • Ternopol, 우크라이나, 46023
        • Local Institution
      • Uzhgorod, 우크라이나, 88014
        • Local Institution
  • 이탈리아
      • Genova, 이탈리아, 16132
        • Local Institution
      • Siena, 이탈리아, 53100
        • Local Institution
      • Torino, 이탈리아, 10143
        • Local Institution
  • 인도
      • Vellore, 인도, 632004
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, 인도, 500082
        • Local Institution
    • Gujarat
      • Navrangpura, Ahmedabad, Gujarat, 인도, 380009
        • Local Institution
    • Karnataka
      • Manipal, Karnataka, 인도, 576104
        • Local Institution
    • Kerala
      • Trivandrum, Kerala, 인도, 695011
        • Local Institution
  • 폴란드
      • Gdansk, 폴란드, 80-952
        • Local Institution
      • Krakow, 폴란드, 31-826
        • Local Institution
      • Olsztyn, 폴란드, 10-513
        • Local Institution
      • Szczecin, 폴란드, 70-891
        • Local Institution
  • 프랑스
      • Belfort, 프랑스, 90016
        • Local Institution
      • Caen, 프랑스, 14076
        • Local Institution
      • Marseille Cedex 9, 프랑스, 13274
        • Local Institution
      • Rennes Cedex 9, 프랑스, 35033
        • Local Institution

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
  • Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
  • Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  • Accessible for treatment and follow-up

Exclusion Criteria:

  • Brain metastases
  • Malignant pleural effusion
  • Autoimmune disease
  • Motor neuropathy of autoimmune origin
  • SCLC-related paraneoplastic syndromes
  • Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)

  • Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.

    • Grade 2 peripheral neuropathy (motor or sensory)
  • Known HIV or hepatitis B or C infection
  • Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
  • Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/dL.
  • Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
  • Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
  • Inadequate creatinine clearance defined as less than 50 mL/min.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
의약품: Ipilimumab
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
의약품: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
의약품: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
의약품: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
실험적: Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
의약품: Ipilimumab
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
의약품: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
의약품: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
의약품: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
활성 비교기: Ipilimumab placebo + paclitaxel + carboplatin
의약품: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
의약품: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
의약품: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
기간: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria
기간: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
Overall Survival in Participants With NSCLC
기간: Randomization date to date of death (of censored, maximum reached: 26.5 months)
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Randomization date to date of death (of censored, maximum reached: 26.5 months)
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC
기간: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)
기간: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC
기간: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.
Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC
기간: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.
Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade
기간: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
기간: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
irPFS in Participants With SCLC Per irRC
기간: Randomization date to date of irPD or death (maximum reached: 22 months)
IRC performed TA.
Randomization date to date of irPD or death (maximum reached: 22 months)
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade
기간: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
기간: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade
기간: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
기간: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade
기간: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
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. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
기간: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade
기간: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade
기간: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria
기간: Randomization date to date of progression or death (of censored, maximum reached: 22 months)
By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
Randomization date to date of progression or death (of censored, maximum reached: 22 months)
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
기간: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.
Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline
기간: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
Overall Survival in Participants With SCLC
기간: Randomization date to date of death (of censored, maximum reached: 22 months)
Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
Randomization date to date of death (of censored, maximum reached: 22 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bristol-Myers Squibb

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 2월 1일

기본 완료 (실제)

2009년 10월 1일

연구 완료 (실제)

2011년 12월 1일

연구 등록 날짜

최초 제출

2007년 9월 7일

QC 기준을 충족하는 최초 제출

2007년 9월 10일

처음 게시됨 (추정)

2007년 9월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 7월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 18일

마지막으로 확인됨

2018년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CA184-041

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

암종, 비소세포폐에 대한 임상 시험

Ipilimumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cyprus

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다