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

Phase 3

Active, not recruiting

• Conditions: Biliary Tract Neoplasms
• Interventions: Drug: KN035 plus Gemcitabine & oxaliplatin; Drug: Gemcitabine & oxaliplatin

• Registration Number: NCT03478488
• Lead Sponsor: 3D Medicines (Sichuan) Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-27
• Study Start: 2018-04-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 480

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KN035	KN035 plus Gemcitabine & oxaliplatin	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 & oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Observed by 12 weeks after progressive disease or end of treatment	was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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)	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)	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)	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)	Observed by 6 weeks	was defined as the time from randomization to the first date that progressive disease was objectively documented

Trial Locations

Locations (1)

The Chinese people's liberation army (PLA) 81hospital; 🇨🇳 Nanjing, Jiangsu, China