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Trial record 7 of 61 for:    PD-1 and breast cancer | Recruiting, Not yet recruiting, Available Studies

A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC (KEYSTONE)

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ClinicalTrials.gov Identifier: NCT03777579
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
TopAlliance Biosciences, Inc.
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: JS001,an engineered anti-PD-1 antibody Drug: Nab-Paclitaxel Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Drug: JS001,an engineered anti-PD-1 antibody
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.
Other Name: Terepril monoclonal antibody

Drug: Nab-Paclitaxel
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.
Other Name: Paclitaxel For Injection(Albumin Bound)

Placebo Comparator: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Drug: Nab-Paclitaxel
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.
Other Name: Paclitaxel For Injection(Albumin Bound)

Drug: Placebo
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC) [ 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) ]
    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 :
  1. Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator [ Time Frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months) ]
    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.

  2. Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC [ Time Frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months) ]
    ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.

  3. Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC [ Time Frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months) ]
    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.

  4. Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC [ Time Frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months) ]
    DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.

  5. Overall Survival (OS) [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    OS is defined as the time from randomization to death from any cause.

  6. OS rate at 12 months [ Time Frame: the percent of participants that are alive at 12months from Day 1. ]
    OS is defined as the time from randomization to death from any cause.

  7. OS rate at 24 months [ Time Frame: the percent of participants that are alive at 24 months from Day 1. ]
    OS is defined as the time from randomization to death from any cause.

  8. PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    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.

  9. ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.

  10. DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    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.

  11. DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.

  12. Percentage and severity of Participants With Adverse Events (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) ]
    percentage and CTC AE(v5.0) of AEs

  13. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC;
  3. Eligible for taxane monotherapy;
  4. Eastern Cooperative Oncology Group performance status of 0 or 1;
  5. Measurable disease as defined by RECIST v1.1;
  6. Adequate hematologic and end-organ function。

Exclusion Criteria:

  1. Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases;
  2. History of autoimmune disease;
  3. History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
  4. Prior allogeneic stem cell or solid organ transplantation;
  5. Active hepatitis B or hepatitis C;
  6. Positive of HIV antibody.

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03777579     History of Changes
Other Study ID Numbers: NABP201801
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Immunoglobulins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs