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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 : Not yet recruiting
First Posted : March 27, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Drug: KN035 plus Gemcitabine & oxaliplatin Drug: Gemcitabine & oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
Estimated Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
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.

Drug: KN035 plus Gemcitabine & oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Other Name: Experimental

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.
Drug: Gemcitabine & oxaliplatin
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Other Name: Active Comparator




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478488


Contacts
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Contact: Lijuan Zhang +86(10) 64882533 lijuan.zhang@3dmedcare.com

Locations
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China, Jiangsu
The Chinese people's liberation army (PLA) 81hospital Active, not recruiting
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
3D Medicines (Sichuan) Co., Ltd.
Investigators
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Principal Investigator: Shukui Qin The Chinese people's liberation army (PLA) 81 hospital

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Responsible Party: 3D Medicines (Sichuan) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03478488     History of Changes
Other Study ID Numbers: KN035-CN-005
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs