Back to resultsA Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
Primary Purpose
Triple Negative Breast Cancer
Status
Suspended
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JS001，an engineered anti-PD-1 antibody
Nab-Paclitaxel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
- No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
- Eligible for taxane monotherapy；
- Eastern Cooperative Oncology Group performance status of 0 or 1；
- Measurable disease as defined by RECIST v1.1；
- Adequate hematologic and end-organ function。
Exclusion Criteria:
- Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
- History of autoimmune disease；
- History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
- Prior allogeneic stem cell or solid organ transplantation;
- Active hepatitis B or hepatitis C;
- Positive of HIV antibody.
Sites / Locations
- The fifth medical center of PLA general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JS001 Plus Nab-Paclitaxel
Placebo Plus Nab-Paclitaxel
Arm Description
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Secondary Outcome Measures
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
OS rate at 12 months
OS is defined as the time from randomization to death from any cause.
OS rate at 24 months
OS is defined as the time from randomization to death from any cause.
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
Percentage and severity of Participants With Adverse Events (AEs)
percentage and CTC AE(v5.0) of AEs
Percentage of Participants With Anti-Drug Antibodies (ATAs)
Full Information
NCT ID
NCT03777579
First Posted
December 12, 2018
Last Updated
August 6, 2019
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03777579
Brief Title
A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
Official Title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Suspended
Why Stopped
trial handovered to another sponser.
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JS001 Plus Nab-Paclitaxel
Arm Type
Experimental
Arm Description
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Arm Title
Placebo Plus Nab-Paclitaxel
Arm Type
Placebo Comparator
Arm Description
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
JS001，an engineered anti-PD-1 antibody
Other Intervention Name(s)
Terepril monoclonal antibody
Intervention Description
JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Other Intervention Name(s)
Paclitaxel For Injection（Albumin Bound）
Intervention Description
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
Description
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time Frame
From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
Description
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time Frame
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Title
Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Description
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
Time Frame
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Title
Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Description
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
Time Frame
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Title
Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Description
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
Time Frame
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Title
OS rate at 12 months
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
the percent of participants that are alive at 12months from Day 1.
Title
OS rate at 24 months
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
the percent of participants that are alive at 24 months from Day 1.
Title
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Description
Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Title
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Description
ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Title
DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Description
DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Title
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Description
DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Title
Percentage and severity of Participants With Adverse Events (AEs)
Description
percentage and CTC AE(v5.0) of AEs
Time Frame
From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
Title
Percentage of Participants With Anti-Drug Antibodies (ATAs)
Time Frame
Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
Eligible for taxane monotherapy；
Eastern Cooperative Oncology Group performance status of 0 or 1；
Measurable disease as defined by RECIST v1.1；
Adequate hematologic and end-organ function。
Exclusion Criteria:
Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
History of autoimmune disease；
History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
Prior allogeneic stem cell or solid organ transplantation;
Active hepatitis B or hepatitis C;
Positive of HIV antibody.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIANG ZE FEI, PHD
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The fifth medical center of PLA general hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
We'll reach out to this number within 24 hrs