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

Biliary Tract Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03478488
• Other study ID #: KN035-CN-005
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2018
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: 3D Medicines
• Contact: Lan Qin
• Phone: +86(10) 64882533
• Email: lan.qin[@]3d-medicines.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

Drug:
• KN035 plus Gemcitabine & oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
• Gemcitabine & oxaliplatin
The standard of care for the patients with unresectable/metastatic biliary tract cancer

Locations

Country	Name	City	State
China	The Chinese people's liberation army (PLA) 81hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
3D Medicines (Sichuan) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	was defined as the time from randomization to death due to any cause.	Observed by 12 weeks after progressive disease or end of treatment
Secondary	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.	Observed by 6 weeks
Secondary	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.	Observed by 6 weeks
Secondary	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	Observed by 6 weeks
Secondary	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)	Observed by 6 weeks
Secondary	Time to progression (TTP)	was defined as the time from randomization to the first date that progressive disease was objectively documented	Observed by 6 weeks