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

6. srpna 2019 aktualizováno: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

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).

Přehled studie

Postavení

Pozastaveno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Očekávaný)

375

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
      • Beijing, Čína
        • The Fifth Medical Center of PLA General Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JS001 Plus Nab-Paclitaxel
Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Lék: 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.
Ostatní jména:
  • Terepril monoclonal antibody
Lék: 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.
Ostatní jména:
  • Paclitaxel For Injection（Albumin Bound）
Komparátor placeba: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
Lék: 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.
Ostatní jména:
  • Paclitaxel For Injection（Albumin Bound）
Lék: Placebo
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
Časové okno: 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.
From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
Časové okno: 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.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Časové okno: 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.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Časové okno: 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.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
Časové okno: 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.
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Overall Survival (OS)
Časové okno: 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.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
OS rate at 12 months
Časové okno: 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.
the percent of participants that are alive at 12months from Day 1.
OS rate at 24 months
Časové okno: 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.
the percent of participants that are alive at 24 months from Day 1.
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Časové okno: 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.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Časové okno: 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.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Časové okno: 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.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Časové okno: 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.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Percentage and severity of Participants With Adverse Events (AEs)
Časové okno: 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
From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
Percentage of Participants With Anti-Drug Antibodies (ATAs)
Časové okno: 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)
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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Vyšetřovatelé

  • Vrchní vyšetřovatel: JIANG ZE FEI, PHD, Beijing 302 Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. prosince 2018

Primární dokončení (Očekávaný)

30. prosince 2019

Dokončení studie (Očekávaný)

30. července 2020

Termíny zápisu do studia

První předloženo

12. prosince 2018

První předloženo, které splnilo kritéria kontroly kvality

13. prosince 2018

První zveřejněno (Aktuální)

17. prosince 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. srpna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. srpna 2019

Naposledy ověřeno

1. prosince 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NABP201801

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na JS001，an engineered anti-PD-1 antibody

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