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

절제 불가능 또는 전이성 대장암 환자에서 베바시주맙 + 카페시타빈과 베바시주맙 + 카페시타빈을 병용한 LBL-007 + Tislelizumab의 효능 및 안전성을 조사한 연구

2026년 7월 21일 업데이트: BeiGene

절제불가능 또는 전이성 현미부수체 안정/불일치 교정 숙련 대장암 환자의 유지 요법으로서 LBL-007 + Tislelizumab과 베바시주맙 + 카페시타빈 병용 요법 대 베바시주맙 + 카페시타빈의 효능 및 안전성을 조사하는 1b/2상, 무작위 공개 라벨 연구

이것은 결장직장암 참가자에게 베바시주맙과 카페시타빈을 병용하여 투여했을 때 LBL-007과 Tislelizumab의 효능과 안전성을 조사하기 위한 1b/2상 연구입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

113

단계

  • 2 단계
  • 1단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alaska
      • Anchorage, Alaska, 미국, 99508-2974
        • Alaska Oncology and Hematology, LLC
    • Arizona
      • Gilbert, Arizona, 미국, 85234-2165
        • Banner MD Anderson Cancer Center
    • California
      • Cerritos, California, 미국, 90703
        • Helios Clinical Research
      • Los Angeles, California, 미국, 90067-2011
        • Valkyrie Clinical Trials
      • Los Angeles, California, 미국, 90089-1019
        • Usc Norris Comprehensive Cancer Center (Nccc)
      • Los Angeles, California, 미국, 90095-3075
        • UCLA Hematologyoncology
      • Newport Beach, California, 미국, 92663-4162
        • Hoag Memorial Presbyterian
      • Vallejo, California, 미국, 94589-2441
        • Kaiser Permanente Northern California
    • Florida
      • Jacksonville, Florida, 미국, 32207-8432
        • Baptist MD Anderson Cancer Center
    • Indiana
      • Fort Wayne, Indiana, 미국, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Kentucky
      • Lexington, Kentucky, 미국, 40536-7001
        • University of Kentucky Markey Cancer Center
      • Lexington, Kentucky, 미국, 40503-1466
        • Baptist Health Lexington
      • Louisville, Kentucky, 미국, 40217-1395
        • Norton Cancer Institute
    • Louisiana
      • Covington, Louisiana, 미국, 70433-7512
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, 미국, 70121-2429
        • Ochsner Clinic Foundation
    • Missouri
      • St Louis, Missouri, 미국, 63110-1010
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, 미국, 59102-6746
        • St Vincent Frontier Cancer Center
    • Nevada
      • Las Vegas, Nevada, 미국, 89169-3321
        • Comprehensive Cancer Centers of Nevada
      • Reno, Nevada, 미국, 89511-2250
        • Cancer Care Specialists
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87102-4517
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Mineola, New York, 미국, 11501-3957
        • Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
      • New York, New York, 미국, 10032
        • Columbia University Medical Center
      • New York, New York, 미국, 10016-2708
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    • North Carolina
      • Durham, North Carolina, 미국, 27710-2000
        • Duke Cancer Center
    • Tennessee
      • Knoxville, Tennessee, 미국, 37920-1511
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, 미국, 75390-7208
        • UT Southwestern Medical Center
      • San Antonio, Texas, 미국, 78229-4427
        • UT Health San Antonio Mays Cancer Center
    • Virginia
      • Fairfax, Virginia, 미국, 22031-2171
        • Virginia Cancer Specialists
    • Washington
      • Spokane Valley, Washington, 미국, 99216-1020
        • Cancer Care Northwest
      • Tacoma, Washington, 미국, 98405
        • MultiCare Health System Institute for Research and Innovation
  • 중국
    • Anhui
      • Hefei, Anhui, 중국, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, 중국, 102218
        • Beijing Tsinghua Changgung Hospital
    • Fujian
      • Fuzhou, Fujian, 중국, 350001
        • Fujian Medical University Union Hospital
      • Quanzhou, Fujian, 중국, 362000
        • Quanzhou First Affliated Hospital of Fujian Medical University
      • Xiamen, Fujian, 중국, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510000
        • ZhuJiang Hospital of Southern Medical University
      • Shantou, Guangdong, 중국, 515041
        • the First Affiliated Hospital of Shantou University Medical College
    • Henan
      • Zhengzhou, Henan, 중국, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, 중국, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, 중국, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nantong, Jiangsu, 중국, 215124
        • Nantong First Peoples Hospital
    • Jilin
      • Changchun, Jilin, 중국, 130021
        • The First Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, 중국, 250117
        • Shandong Cancer Hospital
      • Jining, Shandong, 중국, 272000
        • Jining No1 Peoples Hospital West Branch
      • Linyi, Shandong, 중국, 276000
        • Linyi Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200123
        • Shanghai East Hospital Branch Hospital
      • Shanghai, Shanghai Municipality, 중국, 200000
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, 중국, 030013
        • Shanxi Provincial Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, 중국, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, 중국, 300121
        • Tianjin Union Medical Center (Nankai University Affiliated Hospital)
    • Xinjiang
      • Karamay, Xinjiang, 중국, 834009
        • Karamay Central Hospital of Xinjiang
      • Ürümqi, Xinjiang, 중국, 830001
        • The Xinjiang Uygur Autonomous Region Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • 푸에르토 리코
      • Rio Piedras, 푸에르토 리코, 00935
        • Pan American Oncology Trials, LLC
  • 호주
    • New South Wales
      • Blacktown, New South Wales, 호주, NSW 2148
        • Blacktown Cancer and Haematology Centre
      • Orange, New South Wales, 호주, NSW 2800
        • Orange Health Service (Central West Cancer Care Centre)
      • Wagga Wagga, New South Wales, 호주, NSW 2650
        • Riverina Cancer Care Centre
      • Waratah, New South Wales, 호주, NSW 2298
        • Calvary Mater Newcastle
    • Queensland
      • Benowa, Queensland, 호주, QLD 4217
        • Pindara Private Hospital
    • Victoria
      • Clayton, Victoria, 호주, VIC 3168
        • Monash Health
      • Melbourne, Victoria, 호주, VIC 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, 호주, WA 6150
        • St John of God, Murdoch
      • Nedlands, Western Australia, 호주, WA 6009
        • One Clinical Research

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

14년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 참가자는 RECIST 버전 1.1에 따라 정의된 측정 가능한 질병이 있어야 합니다.
  • 조직학적으로 확인된 전이성 또는 절제 불가능한 질환이 있는 결장직장 선암종(미국 합동 암 위원회[AJCC] 8판에서 정의한 IV기)
  • 1차 요법의 유도 치료를 제외하고 전이성 환경에서 결장직장암(CRC)에 대한 사전 전신 요법이 없습니다. 참고: 유도전신치료 시 국소 부위 치료 가능
  • 1차 유도 치료를 완료한 자로서 전반적 반응이 안정 질환 이상인 자

제외 기준:

  • 유도 치료 중 또는 유도 치료 후 조사자의 재량에 따라 질병이 절제 가능하게 된 참가자는 자격이 없습니다.
  • 이전 신보강 또는 보조 화학요법 또는 방사선요법 완료 후 6개월 이내에 시작된 유도 치료
  • 유도 치료에서 항 표피 성장 인자 수용체(EGFR) 항체로 치료를 받은 참가자
  • T-세포 자극 또는 체크포인트 경로를 표적으로 하는 모든 이전 요법
  • 현지 평가에 의해 기록된 B-raf 원발암유전자, 세린/트레오닌 키나아제(BRAF) 돌연변이가 있는 참가자
  • PCR(polymerase chain reaction) 방법 또는 dMMR(deficient mismatch repair) 면역조직화학(IHC)에 의해 국소 또는 중앙에서 확인된 현미부수체 불안정성 높음(MSI-H)이 있습니다. 지역 결과가 권장되며 등록이 허용됩니다. 현지 테스트 결과가 없는 참가자는 중앙 실험실 평가를 받아야 합니다. 참고: MMR(mismatch repair) 결핍 또는 MSI-H 상태가 없는 종양이 있는 CRC 환자는 pMMR 또는 MSS(microsatellite stable)로 분류됩니다.

참고: 다른 프로토콜 정의 기준이 적용될 수 있습니다.

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
다른 이름들:
  • BGB-A317
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
실험적: Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine
Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
다른 이름들:
  • BGB-A317
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
실험적: Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine

Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent.

The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
다른 이름들:
  • BGB-A317
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
실험적: Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine
PD-L1 (programmed cell death protein ligand-1)-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
다른 이름들:
  • BGB-A317
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
실험적: Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine
PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
활성 비교기: Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine

PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
실험적: Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine
PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Alcestobart

Administered intravenously (IV) at one of the following doses

  • Low dose: 150 mg once every 3 weeks
  • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
  • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks
다른 이름들:
  • LBL-007
의약품: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
다른 이름들:
  • BGB-A317
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
활성 비교기: Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine

PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent.

The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
의약품: Bevacizumab or Bevacizumab biosimilar
Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.
의약품: Fluoropyrimidine (FP)

Fluoropyrimidine treatment included one of the following:

- Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

OR

- 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
기간: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

  • resulted in death,
  • was life threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
기간: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
기간: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
기간: From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
기간: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
기간: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))

ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))
Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E
기간: From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.
From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)
Phase 2: Number of Participants With Treatment-emergent AEs and SAEs
기간: From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

  • resulted in death,
  • was life threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity,
  • was a congenital anomaly/birth defect.
From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BeiGene

수사관

  • 연구 책임자: Study Director, BeiGene

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 (실제)

2023년 1월 29일

기본 완료 (실제)

2025년 5월 23일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2022년 10월 20일

QC 기준을 충족하는 최초 제출

2022년 11월 1일

처음 게시됨 (실제)

2022년 11월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BGB-A317-LBL-007-201
  • CTR20223077 (레지스트리 식별자: ChinaDrugTrials)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

베이 젠 (Beigene)은 책임감있게 완성 된 연구에 대한 데이터를 공유하고 자격을 갖춘 과학 및 의료 연구원에게 미국, 중국 및 유럽에 제출 및 승인을 한 후 의약품 및 징후에 대한 서류의 임상 시험에 대한 데이터에 대한 액세스 및 지원 문서를 제공합니다. 후속 지역 승인, 새로운 적응증 또는 조합 제품을 지원하는 임상 시험은 해당 규제 승인이 달성되면 공유 할 수 있습니다.

Beigene은 해당 데이터 개인 정보 보호 및 보안법 및 규정에 의해 허용 된 경우에만 데이터를 공유합니다. 연구 참여자의 개인 정보를 손상시키지 않으면 서 그렇게 할 수있는 경우 및 기타 고려 사항.

새로운 과학 연구에 참여한 적절한 역량을 가진 자격을 갖춘 연구원은 베이 엔 검토를위한 연구 제안서와 함께 참가자 수준 데이터 요청을 제출할 수 있습니다. 연구팀은 생물 역학 주의자를 포함하고 임상 시험 데이터에 대한 액세스를 받기 전에 데이터 공유 계약에 서명해야합니다.

IPD 공유 기간

계획 설명을 참조하십시오

IPD 공유 액세스 기준

계획 설명을 참조하십시오

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

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. .

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