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Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (KN035-BTC)

Primary Purpose

Biliary Tract Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
KN035 plus Gemcitabine & oxaliplatin
Gemcitabine & oxaliplatin
Sponsored by
3D Medicines (Sichuan) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms

Eligibility Criteria

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

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;

Sites / Locations

  • The Chinese people's liberation army (PLA) 81hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KN035

Gemcitabine & oxaliplatin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Progression Free Survival (PFS)
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)
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)
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)
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)
was defined as the time from randomization to the first date that progressive disease was objectively documented

Full Information

First Posted
March 21, 2018
Last Updated
April 9, 2023
Sponsor
3D Medicines (Sichuan) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03478488
Brief Title
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Acronym
KN035-BTC
Official Title
Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3D Medicines (Sichuan) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KN035
Arm Type
Experimental
Arm Description
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.
Arm Title
Gemcitabine & oxaliplatin
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
KN035 plus Gemcitabine & oxaliplatin
Other Intervention Name(s)
Experimental
Intervention Description
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Intervention Type
Drug
Intervention Name(s)
Gemcitabine & oxaliplatin
Other Intervention Name(s)
Active Comparator
Intervention Description
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
was defined as the time from randomization to death due to any cause.
Time Frame
Observed by 12 weeks after progressive disease or end of treatment
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Observed by 6 weeks
Title
Objective response rate (ORR)
Description
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.
Time Frame
Observed by 6 weeks
Title
Disease control rate (DCR)
Description
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
Time Frame
Observed by 6 weeks
Title
Duration of Response (DOR)
Description
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 Frame
Observed by 6 weeks
Title
Time to progression (TTP)
Description
was defined as the time from randomization to the first date that progressive disease was objectively documented
Time Frame
Observed by 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Zhang
Phone
+86(10) 64882533
Email
yun.zhang@3d-medicines.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin
Organizational Affiliation
The Chinese people's liberation army (PLA) 81 hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese people's liberation army (PLA) 81hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiufeng Liu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

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