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En studie som undersøker effektiviteten og sikkerheten til LBL-007 Plus Tislelizumab i kombinasjon med Bevacizumab Plus Capecitabine versus Bevacizumab Plus Capecitabin hos deltakere med ikke-opererbar eller metastatisk tykktarmskreft

21. juli 2026 oppdatert av: BeiGene

En fase 1b/2, randomisert, åpen studie som undersøker effektiviteten og sikkerheten til LBL-007 Plus Tislelizumab i kombinasjon med Bevacizumab Plus Capecitabine versus Bevacizumab Plus Capecitabin som vedlikeholdsterapi hos pasienter med uopererbar eller metastatisk mikrosatellitt reparasjonskanne Proficient/Mismatch Color

Dette er en fase 1b/2-studie for å undersøke effektiviteten og sikkerheten til LBL-007 pluss Tislelizumab når det administreres i kombinasjon med bevacizumab pluss kapecitabin til deltakere med tykktarmskreft.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

113

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Deltakeren må ha målbar sykdom som definert i RECIST versjon 1.1
  • Har et histologisk bekreftet kolorektalt adenokarsinom med metastatisk eller ikke-opererbar sykdom (stadium IV som definert av American Joint Committee on Cancer [AJCC] 8. utgave)
  • Ingen tidligere systemisk terapi for kolorektal kreft (CRC) i metastatisk setting bortsett fra induksjonsbehandling av førstelinjebehandling. Merk: Lokal regional behandling utført under systemisk induksjonsbehandling er tillatt
  • Deltakere som har fullført førstelinjeinduksjonsbehandlingen, med en samlet respons på stabil sykdom eller bedre

Ekskluderingskriterier:

  • Deltakere hvis sykdom har blitt resecerbar etter etterforskerens skjønn under eller etter induksjonsbehandling er ikke kvalifisert
  • Induksjonsbehandling startet mindre enn 6 måneder etter fullføring av tidligere neoadjuvant eller adjuvant kjemoterapi eller strålebehandling
  • Deltakere som har blitt behandlet med anti-epidermal vekstfaktor reseptor (EGFR) antistoff i induksjonsbehandlingen
  • Enhver tidligere terapi rettet mot T-cellestimulering eller sjekkpunktveier
  • Deltakere med dokumentert B-raf proto-onkogen, serin/treoninkinase (BRAF) mutasjoner ved lokale vurderinger
  • Har lokalt eller sentralt bekreftet mikrosatellitt-instabilitet-høy (MSI-H) ved polymerasekjedereaksjon (PCR) metode eller mangelfull mismatch reparasjon (dMMR) immunhistokjemi (IHC). Lokale resultater anbefales og aksepteres for påmelding. Deltakere uten lokale testresultater må ha en sentral laboratorievurdering. Merk: CRC-pasienter med svulster uten mismatch repair (MMR) mangel eller MSI-H status er kategorisert som pMMR eller mikrosatellitt stabil (MSS)

Merk: Andre protokolldefinerte kriterier kan gjelde.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navn:
  • BGB-A317
Legemiddel: 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.
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navn:
  • BGB-A317
Legemiddel: 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.
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navn:
  • BGB-A317
Legemiddel: 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.
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navn:
  • BGB-A317
Legemiddel: 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.
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: 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.
Legemiddel: 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.
Aktiv komparator: 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).
Legemiddel: 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.
Legemiddel: 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.
Eksperimentell: 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).
Legemiddel: 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
Andre navn:
  • LBL-007
Legemiddel: Tislelizumab
Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.
Andre navn:
  • BGB-A317
Legemiddel: 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.
Legemiddel: 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.
Aktiv komparator: 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).
Legemiddel: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BeiGene

Etterforskere

  • Studieleder: Study Director, BeiGene

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. januar 2023

Primær fullføring (Faktiske)

23. mai 2025

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

20. oktober 2022

Først innsendt som oppfylte QC-kriteriene

1. november 2022

Først lagt ut (Faktiske)

8. november 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Beigene deler data om fullførte studier på en ansvarlig måte og gir kvalifiserte vitenskapelige og medisinske forskere tilgang til data og støttende dokumentasjon for kliniske studier i dossier for medisiner og indikasjoner etter innsending og godkjenning i USA, Kina og Europa. Kliniske studier som støtter påfølgende lokale godkjenninger, nye indikasjoner eller kombinasjonsprodukter er kvalifisert for deling når tilsvarende regulatoriske godkjenninger oppnås.

Beigene deler data bare når det er tillatt av gjeldende data om personvern og sikkerhetslover og forskrifter, når det er mulig å gjøre det uten at det går ut over personvernet til deltakere og andre hensyn.

Kvalifiserte forskere med passende kompetanse som driver med ny vitenskapelig forskning, kan sende inn en forespørsel om data på deltakernivå med et forskningsforslag for Beigene Review. Forskerteam må omfatte en biostatistiker og signere en datadelingsavtale før du mottar tilgang til kliniske studiedata.

IPD-delingstidsramme

Se planbeskrivelse

Tilgangskriterier for IPD-deling

Se planbeskrivelse

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere