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

3D Medicines

Status and phase: Active, not recruiting; Phase 3

Conditions: Biliary Tract Neoplasms

Treatments: Drug: Gemcitabine & oxaliplatin; Drug: KN035 plus Gemcitabine & oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03478488

KN035-CN-005

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

KN035

Experimental group

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.

Treatment:

Drug: KN035 plus Gemcitabine & oxaliplatin

Gemcitabine & oxaliplatin

Active Comparator group

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.

Treatment:

Drug: Gemcitabine & oxaliplatin