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A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

Primary Purpose

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LBL-007
LBL-007
LBL-007
Tislelizumab
Tislelizumab
Bevacizumab biosimilar
Bevacizumab biosimilar
Capecitabine
5-Fluorouracil
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer focused on measuring Colorectal Cancer, Microsatellite Stable, Mismatch Repair Proficient, Maintenance Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant must have measurable disease as defined per RECIST version 1.1 Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition) No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed Participants who have completed the first-line induction treatment, with an overall response of stable disease or better Exclusion Criteria: Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment Any prior therapy targeting T-cell stimulation or checkpoint pathways Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method Note: Other protocol defined criteria may apply.

Sites / Locations

  • Alaska Oncologyand Hematology, LlcRecruiting
  • Banner Md Anderson Cancer CenterRecruiting
  • Usc Norris Comprehensive Cancer Center (Nccc)Recruiting
  • Valkyrie Clinical TrialsRecruiting
  • Pontchartrain Cancer CenterRecruiting
  • Washington University School of MedicineRecruiting
  • St Vincent Frontier Cancer CenterRecruiting
  • Nyu Perlmutter Cancer CenterRecruiting
  • Blacktown Cancer and Haematology CentreRecruiting
  • Border Medical OncologyRecruiting
  • Pindara Private HospitalRecruiting
  • Icon Cancer Care South BrisbaneRecruiting
  • Monash HealthRecruiting
  • The Alfred HospitalRecruiting
  • St John of God, MurdochRecruiting
  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Gansu Provincial HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • The First Affiliated Hospital of Shantou University Medical CollegeRecruiting
  • Nanyang Central HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Hubei Cancer HospitalRecruiting
  • The First Peoples Hospital of ChangzhouRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Shandong Cancer HospitalRecruiting
  • Jining No Peoples HospitalRecruiting
  • Linyi Peoples HospitalRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Shanghai Th Peoples HospitalRecruiting
  • Shanghai East Hospital Branch HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Karamay Central Hospital of XinjiangRecruiting
  • Zhejiang University College of Medicine Second Affiliated HospitalRecruiting
  • Pan American Oncology Trials, LlcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Experimental

Arm Label

Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine

Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine

Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine

Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine

Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine

Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine

Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)

Arm Description

LBL-007 + tislelizumab + bevacizumab + capecitabine

LBL-007 + tislelizumab + bevacizumab + capecitabine

LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks)+ fluoropyrimidine (5-FU or capecitabine)

LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)

LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)

bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)

LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil

Outcomes

Primary Outcome Measures

Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE)
AEs and SAE are characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v5.0])
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
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

Secondary Outcome Measures

Phase 2: Overall Survival (OS) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
OS is defined as the time from the date of randomization until the date of death from any cause.
Phase 2: PFS 2 as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
PFS2 is defined as the time from the date of randomization to the date of documentation of disease progression in second-line treatment, or death, whichever occurs first
Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
Phase 2: Duration of response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative arms D and E
DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
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
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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
Phase 2: Overall Survival (OS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
OS is defined as the time from the date of randomization until the date of death from any cause.
Phase 2: PFS 2 as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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
Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
Phase 2: DOR as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
Phase 2 : Number of participants with Adverse events (AE) and Serious AEs (SAE)
AEs and SAE are characterized by type, frequency, severity as graded by NCI-CTCAE v5.0
Phase 1b: Maximum Concentration (Cmax) of LBL-007
Phase 1b: Time to achieve Maximum Concentration (Tmax) of LBL-007
Phase 1b: Area Under the Concentration Curve from Day 0 to Day 21(AUC 0-21)
Phase 1b: Mean Half Life (t1/2) of LBL-007
Phase 1b: Clearance (CL) of LBL-007
Phase 1b: Apparent Volume of Distribution (Vz) of LBL-007
Phase 2: Cmax of LBL-007, Tislelizumab, and Bevacizumab
Phase 2: Cmin of LBL-007, Tislelizumab, and Bevacizumab
Number of Participants with anti-drug antibodies (ADAs) to Tislelizumab, and Bevacizumab in Arm A, Arm B and Arm D

Full Information

First Posted
October 20, 2022
Last Updated
October 18, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05609370
Brief Title
A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
Official Title
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2023 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus Tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine to participants with colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Keywords
Colorectal Cancer, Microsatellite Stable, Mismatch Repair Proficient, Maintenance Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm Type
Experimental
Arm Description
LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm Title
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm Type
Experimental
Arm Description
LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm Title
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm Type
Experimental
Arm Description
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks)+ fluoropyrimidine (5-FU or capecitabine)
Arm Title
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm Type
Experimental
Arm Description
LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Arm Title
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Arm Type
Experimental
Arm Description
LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Arm Title
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
Arm Type
Other
Arm Description
bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Arm Title
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Arm Type
Experimental
Arm Description
LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
Low dose intravenously (IV) once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
Medium dose IV once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
High dose IV once every 2 or 3 weeks
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A-317
Intervention Description
Low dose IV once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A-317
Intervention Description
High dose IV once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab biosimilar
Intervention Description
7.5 mg/kg IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab biosimilar
Intervention Description
5 mg/kg IV once every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
1600 to 2400 mg/m^2 IV every 2 weeks
Primary Outcome Measure Information:
Title
Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE)
Description
AEs and SAE are characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v5.0])
Time Frame
First Cycle of treatment (21 days)
Title
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Description
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
Time Frame
Approximately 44 months
Secondary Outcome Measure Information:
Title
Phase 2: Overall Survival (OS) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
Description
OS is defined as the time from the date of randomization until the date of death from any cause.
Time Frame
Approximately 44 months
Title
Phase 2: PFS 2 as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
Description
PFS2 is defined as the time from the date of randomization to the date of documentation of disease progression in second-line treatment, or death, whichever occurs first
Time Frame
Approximately 44 months
Title
Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
Description
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
Time Frame
Approximately 44 months
Title
Phase 2: Duration of response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative arms D and E
Description
DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
Time Frame
Approximately 44 months
Title
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Description
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
Time Frame
Approximately 44 months
Title
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Description
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
Time Frame
Approximately 44 months
Title
Phase 2: Overall Survival (OS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Description
OS is defined as the time from the date of randomization until the date of death from any cause.
Time Frame
Approximately 44 months
Title
Phase 2: PFS 2 as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Description
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
Time Frame
Approximately 44 months
Title
Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Description
ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
Time Frame
Approximately 44 months
Title
Phase 2: DOR as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Description
DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
Time Frame
Approximately 44 months
Title
Phase 2 : Number of participants with Adverse events (AE) and Serious AEs (SAE)
Description
AEs and SAE are characterized by type, frequency, severity as graded by NCI-CTCAE v5.0
Time Frame
Up to last dose + 30 days (Approximately 44 months)
Title
Phase 1b: Maximum Concentration (Cmax) of LBL-007
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 1b: Time to achieve Maximum Concentration (Tmax) of LBL-007
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 1b: Area Under the Concentration Curve from Day 0 to Day 21(AUC 0-21)
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 1b: Mean Half Life (t1/2) of LBL-007
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 1b: Clearance (CL) of LBL-007
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 1b: Apparent Volume of Distribution (Vz) of LBL-007
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Phase 2: Cmax of LBL-007, Tislelizumab, and Bevacizumab
Time Frame
Up to approximately 27 months (predose at cycle 1,2,5,9,17, safety follow-up (each cycle 21 days))
Title
Phase 2: Cmin of LBL-007, Tislelizumab, and Bevacizumab
Time Frame
Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
Title
Number of Participants with anti-drug antibodies (ADAs) to Tislelizumab, and Bevacizumab in Arm A, Arm B and Arm D
Time Frame
Up to approximately 27 months (predose at cycle 1,2,5,9,17, safety follow-up, and EOI at cycle 1 and 5 (each cycle 21 days))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have measurable disease as defined per RECIST version 1.1 Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition) No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed Participants who have completed the first-line induction treatment, with an overall response of stable disease or better Exclusion Criteria: Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment Any prior therapy targeting T-cell stimulation or checkpoint pathways Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method Note: Other protocol defined criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
Alaska Oncologyand Hematology, Llc
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Banner Md Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Name
Usc Norris Comprehensive Cancer Center (Nccc)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Pontchartrain Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Name
Nyu Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Blacktown Cancer and Haematology Centre
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Border Medical Oncology
City
East Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God, Murdoch
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Gansu Provincial Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
The First Peoples Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No Peoples Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Name
Linyi Peoples Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Th Peoples Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital Branch Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Karamay Central Hospital of Xinjiang
City
Karamay
State/Province
Xinjiang
ZIP/Postal Code
834009
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang University College of Medicine Second Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Pan American Oncology Trials, Llc
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

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