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Een onderzoek naar de werkzaamheid en veiligheid van LBL-007 plus Tislelizumab in combinatie met bevacizumab plus capecitabine versus bevacizumab plus capecitabine bij deelnemers met inoperabele of gemetastaseerde colorectale kanker

21 juli 2026 bijgewerkt door: BeiGene

Een fase 1b/2, gerandomiseerd, open-label onderzoek naar de werkzaamheid en veiligheid van LBL-007 plus Tislelizumab in combinatie met bevacizumab plus capecitabine versus bevacizumab plus capecitabine als onderhoudstherapie bij patiënten met niet-reseceerbare of gemetastaseerde microsatelliet stabiele/mismatch-reparatie vaardige colorectale kanker

Dit is een fase 1b/2-studie om de werkzaamheid en veiligheid van LBL-007 plus Tislelizumab te onderzoeken bij toediening in combinatie met bevacizumab plus capecitabine aan deelnemers met colorectale kanker.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

113

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Deelnemer moet een meetbare ziekte hebben zoals gedefinieerd in RECIST versie 1.1
  • Heeft een histologisch bevestigd colorectaal adenocarcinoom met gemetastaseerde of inoperabele ziekte (stadium IV zoals gedefinieerd door American Joint Committee on Cancer [AJCC] 8e editie)
  • Geen eerdere systemische therapie voor colorectale kanker (CRC) in de gemetastaseerde setting, behalve de inductiebehandeling van eerstelijnstherapie. Opmerking: Lokale regionale behandeling uitgevoerd tijdens inductie systemische behandeling is toegestaan
  • Deelnemers die de eerstelijns inductiebehandeling hebben voltooid, met een algehele respons van stabiele ziekte of beter

Uitsluitingscriteria:

  • Deelnemers van wie de ziekte resectabel is geworden naar goeddunken van de onderzoeker tijdens of na de inductiebehandeling komen niet in aanmerking
  • Inductiebehandeling gestart minder dan 6 maanden na voltooiing van eerdere neoadjuvante of adjuvante chemotherapie of radiotherapie
  • Deelnemers die zijn behandeld met anti-epidermale groeifactorreceptor (EGFR)-antilichaam in de inductiebehandeling
  • Elke eerdere therapie gericht op T-celstimulatie of checkpoint-routes
  • Deelnemers met gedocumenteerde B-raf proto-oncogen, serine/threonine kinase (BRAF) mutaties door lokale beoordelingen
  • Lokaal of centraal bevestigde microsatelliet instabiliteit-hoog (MSI-H) door polymerase kettingreactie (PCR) methode of deficiënte mismatch reparatie (dMMR) immunohistochemie (IHC). Lokaal resultaat wordt aanbevolen en acceptabel voor inschrijving. Deelnemers zonder lokale testresultaten moeten een centrale laboratoriumbeoordeling hebben. Opmerking: CRC-patiënten met tumoren zonder mismatch repair (MMR)-deficiëntie of MSI-H-status worden gecategoriseerd als pMMR of microsatellietstabiel (MSS)

Opmerking: er kunnen andere in het protocol gedefinieerde criteria van toepassing zijn.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andere namen:
  • BGB-A317
Geneesmiddel: 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.
Geneesmiddel: 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.
Experimenteel: 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).
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andere namen:
  • BGB-A317
Geneesmiddel: 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.
Geneesmiddel: 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.
Experimenteel: 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).
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andere namen:
  • BGB-A317
Geneesmiddel: 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.
Geneesmiddel: 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.
Experimenteel: 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).
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andere namen:
  • BGB-A317
Geneesmiddel: 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.
Geneesmiddel: 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.
Experimenteel: 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).
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: 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.
Geneesmiddel: 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.
Actieve vergelijker: 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).
Geneesmiddel: 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.
Geneesmiddel: 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.
Experimenteel: 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).
Geneesmiddel: 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
Andere namen:
  • LBL-007
Geneesmiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andere namen:
  • BGB-A317
Geneesmiddel: 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.
Geneesmiddel: 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.
Actieve vergelijker: 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).
Geneesmiddel: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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Sponsor

BeiGene

Onderzoekers

  • Studie directeur: Study Director, BeiGene

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 januari 2023

Primaire voltooiing (Werkelijk)

23 mei 2025

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

20 oktober 2022

Eerst ingediend dat voldeed aan de QC-criteria

1 november 2022

Eerst geplaatst (Werkelijk)

8 november 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BGB-A317-LBL-007-201
  • CTR20223077 (Register-ID: ChinaDrugTrials)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Beigene deelt gegevens over voltooide studies verantwoordelijk en biedt gekwalificeerde wetenschappelijke en medische onderzoekers toegang tot gegevens en ondersteunende documentatie voor klinische proeven in dossiers voor medicijnen en indicaties na indiening en goedkeuring in de Verenigde Staten, China en Europa. Klinische proeven ter ondersteuning van latere lokale goedkeuringen, nieuwe indicaties of combinatieproducten komen in aanmerking voor het delen zodra overeenkomstige regelgevende goedkeuringen zijn bereikt.

Beigene deelt gegevens alleen wanneer toegestaan ​​door toepasselijke gegevensprivacy- en beveiligingswetten en -voorschriften, wanneer het mogelijk is om dit te doen zonder de privacy van deelnemers aan de studie en andere overwegingen in gevaar te brengen.

Gekwalificeerde onderzoekers met passende competenties die zich bezighouden met nieuw wetenschappelijk onderzoek, kunnen een verzoek om gegevens op deelnemersniveau indienen met een onderzoeksvoorstel voor Beigene Review. Onderzoeksteams moeten een biostatisticus opnemen en een overeenkomst voor het delen van gegevens ondertekenen voordat ze toegang krijgen tot gegevens van klinische proef.

IPD-tijdsbestek voor delen

Zie planbeschrijving

IPD-toegangscriteria voor delen

Zie planbeschrijving

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren