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Trial record 1 of 1 for:    NCT03478488
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Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (KN035-BTC)

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ClinicalTrials.gov Identifier: NCT03478488
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
3D Medicines ( 3D Medicines (Sichuan) Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date March 23, 2021
Actual Study Start Date  ICMJE April 16, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
Overall Survival (OS) [ Time Frame: Observed by 12 weeks after progressive disease or end of treatment ]
was defined as the time from randomization to death due to any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
Overall Survival (OS) [ Time Frame: Observed by 12 weeks after PD or end of treatment ]
was defined as the time from randomization to death due to any cause.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review.
  • Objective response rate (ORR) [ Time Frame: Observed by 6 weeks ]
    was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation.
  • Disease control rate (DCR) [ Time Frame: Observed by 6 weeks ]
    was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation
  • Duration of Response (DOR) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from the first met for complete response/partial response (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study)
  • Time to progression (TTP) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from randomization to the first date that progressive disease was objectively documented
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Progression Free Survival (PFS) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review.
  • Objective response rate (ORR) [ Time Frame: Observed by 6 weeks ]
    was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation.
  • Disease control rate (DCR) [ Time Frame: Observed by 6 weeks ]
    was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation
  • Duration of Response (DOR) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from the first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study)
  • Time to progression (TTP) [ Time Frame: Observed by 6 weeks ]
    was defined as the time from randomization to the first date that progressive disease was objectively documented
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Official Title  ICMJE Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
Brief Summary

This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer.

The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Neoplasms
Intervention  ICMJE
  • Drug: KN035 plus Gemcitabine & oxaliplatin
    KN035 a programmed death ligand immune check inhibitor Per Investigator decision
    Other Name: Experimental
  • Drug: Gemcitabine & oxaliplatin
    The standard of care for the patients with unresectable/metastatic biliary tract cancer
    Other Name: Active Comparator
Study Arms  ICMJE
  • Experimental: KN035

    KN035 plus Gemcitabine & oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle.

    Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.

    Intervention: Drug: KN035 plus Gemcitabine & oxaliplatin
  • Active Comparator: Gemcitabine & oxaliplatin
    Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.
    Intervention: Drug: Gemcitabine & oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2021)
480
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
390
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eighteen years and older;
  • Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
  • Previously untreated with systemic therapy; Subjects who developed recurrent disease >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
  • Liver function Child-Pugh A or B;
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  • Life expectancy of at least 12 weeks;
  • At least one measurable lesion per RECIST 1.1;
  • Adequate organ function

Exclusion Criteria:

  • Specific anti-tumor treatment prior to 4 weeks;
  • more than 50% liver metastasis ;
  • Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
  • History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
  • Women who are pregnant or in the period of lactation;
  • Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Siyin Xu +86(10) 64882533 siyin.xu@3d-medicines.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03478488
Other Study ID Numbers  ICMJE KN035-CN-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party 3D Medicines ( 3D Medicines (Sichuan) Co., Ltd. )
Study Sponsor  ICMJE 3D Medicines (Sichuan) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shukui Qin The Chinese people's liberation army (PLA) 81 hospital
PRS Account 3D Medicines
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP