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Pembrolizumab as Neoadjuvant Treatment in HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337841
Recruitment Status : Unknown
Verified November 2017 by Masatoshi Kudo, Kindai University.
Recruitment status was:  Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Masatoshi Kudo, Kindai University

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date November 9, 2017
Estimated Study Start Date  ICMJE November 10, 2017
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
One-year recurrence-free survival rate [ Time Frame: 1 year after curative treatment ]
One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Recurrence free survival [ Time Frame: From the date of enrollment until the date of first recurrence or date of death from any cause, whichever came first, up to 72 weeks. ]
    Recurrence-free survival is defined as the length of time from the date of confirmation of complete cure to the earliest of the following: the date when recurrence is diagnosed or the date of death due to any cause.
  • Overall survival [ Time Frame: From date of enrollment until the date of death from any cause, up to 72 weeks. ]
    Overall survival is defined as the length of time from the date of confirmation of complete cure to the date of death due to any cause.
  • Objective response rate after neoadjuvant phase [ Time Frame: Evaluation period is just before curative treatment, up to 4 weeks. ]
    Tumor assessment in accordance with RECIST1.1 will be performed after neoadjuvant administration.
  • Tumor markers [ Time Frame: From the date of enrollment until the date of last administration of study drug, up to 72 weeks. ]
    Baseline levels of tumor markers including AFP, AFP-L3, and PIVKA-II and changes in their levels will be exploratory investigated in relation to the therapy efficacy.
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From the date of enrollment until the date of last administration of study drug, thereafter up to 4 months ]
    The safety endpoints of this study are the safety of pembrolizumab as neoadjuvant and/or adjuvant therapy in patients with HCC. To determine the safety of the drug, the degree of toxicity is evaluated in accordance with the CTCAE (version 4.0).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pembrolizumab as Neoadjuvant Treatment in HCC
Official Title  ICMJE Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)
Brief Summary The aim of this study is to elucidate the utility of the immune checkpoint inhibitor pembrolizumab in preventing the recurrence of HCC when administered before and after curative surgery or ablation.
Detailed Description Each subject will participate in the trial from the time he or she signs the informed consent form until the final contact. After a screening phase of up to 28 days, each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.) Subjects who discontinue for reasons other than tumor recurrence will have post-treatment follow-up visits for monitoring disease status until tumor recurrence, until initiation of non-study cancer treatment, until withdrawal of consent for study participation, or until becoming lost to follow-up. All subjects will be followed for overall survival until death, withdrawal of consent for study participation, or the end of the study, whichever comes first. After the end of trial treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: Pembrolizumab
Each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.)
Other Names:
  • MK-3475
  • Keytruda
Study Arms  ICMJE Experimental: Pembrolizumab
Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase.
Intervention: Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hepatocellular carcinoma for which radical cure is possible by resection or RFA.
  • Diagnosed with typical HCC based on imaging findings with Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Male or female subjects >/= 20 years of age
  • Child-Pugh score A
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Recurrent HCC
  • HCC with extrahepatic metastasis and/or vascular invasion confirmed by diagnostic imaging
  • Subjects with poorly controlled ascites (excluding cases that responded to diuretic therapy)
  • Subjects with hepatic encephalopathy
  • Past history of immunotherapy
  • Past history or complication of an active autoimmune disorder.
  • Past history or complication of interstitial pneumonia.
  • Past or current history of malignant tumor, except for curative cases
  • Subjects with renal insufficiency requiring hemodialysis or peritoneal dialysis.
  • Past or current history of severe cardiovascular disease
  • Active clinically serious infections except for HBV or HCV
  • Subjects with convulsive disorder requiring treatment (risk of convulsive seizures).
  • Subjects with gastrointestinal bleeding causing clinical problems within a 4-week period before enrollment in this study.
  • Subjects with thrombosis or embolism that developed within a 6-month period before enrollment in this study
  • Subjects with pregnant or breast feeding, or planning to become a parent
  • Subjects with possible allergic reaction to the investigational drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03337841
Other Study ID Numbers  ICMJE AURORA study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Masatoshi Kudo, Kindai University
Study Sponsor  ICMJE Kindai University
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Masatoshi Kudo, Professor Kindai University Faculty of Medicine, Gastroenterology and Hepatology
PRS Account Kindai University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP