The study will assess the safety of the association of NP137 with the standard of care Atezolizumab-Bevacizumab in first line setting in patients with unresectable hepatocellular carcinoma. The study drug which is tested is the NP137 in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.
The study is a multicentric, prospective, single arm phase 1b trial. This study will enroll 43 to 52 patients and consists of 2 parts: Safety Lead-in Phase and Expansion Phase. Initially, 3 to 12 patients will be enrolled into a Safety Lead-in Phase based on a 3 + 3 design, with the possibility of dose de-escalation, to confirm the recommended dose of NP137. The Expansion Phase will start after completion of Safety Lead-in Phase at the confirmed dose and will include 40 patients. Patients will be assigned to the experimental single arm (NP137+ Atezolizumab-Bevacizumab).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
NP137 at 9 or 14 mg/kg IV will be administered every 21 days.
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-days cycle
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle
CHU de GRENOBLE ALPES
Grenoble, Alpes, France
CHU Angers
Angers, France
Hôpital Haut Lêveque
Bordeaux, France
12 Hôpital St Joseph
Marseille, France
Percentage Proportion of patients experiencing adverse events
Percentage Proportion of patients experiencing adverse events (AEs) of any grade and grade 3/4 AEs as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE v 5.0) throughout the study period.
Time frame: At 36 months
Best overall objective response rate (ORR)
Best overall objective response rate (ORR) and ORR at 3 months, 6, 9, 12 months according to mRECIST and RECIST 1.1.
Time frame: At 36 months
Overall survival (OS)
Median Overall survival (OS) at 6, 12, 18, 24 and 36 months-OS rates. OS is defined as the time between the first administration of the association NP137 + Atezolizumab-Bevacizumab and death (all causes). Patients alive will be censored at the date of last news.
Time frame: At 36 months
Progression-Free Survival (PFS)
Median Progression-Free Survival (PFS), 6, 12, 18, 24 and 36 months-PFS rates according to RECIST 1.1. PFS is defined as the time between the first administration of the association NP137 + Atezolizumab-Bevacizumab and progression according to RECIST 1.1 or death (all causes). Patients alive without progression will be censored at the date of last news.
Time frame: At 36 months
Duration of response
Median Duration of response is defined as the time between onset of response (first PR or CR status) and progression according to RECIST 1.1. Patients alive without progression will be censored at the date of last news.
Time frame: At 36 months
Alpha-fetoprotein (AFP) response
AFP response will be defined as a percentage of patients with a ≥ 50% reduction from baseline AFP level, at 3, 6, 12 months
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CHU Nantes
Nantes, France
AP-HP Beaujon
Paris, France
AP-HP St Antoine
Paris, France
CHU Reims
Reims, France
CHU Toulouse
Toulouse, France
Time frame: At 36 months
Quality of life (QoL)
QoL will be studied by using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire for Cancer at baseline, 3, 6, 12 months. A 5-point decrease of QLQ-C30 score will be considered as the minimal clinically significant deterioration of QoL.
Time frame: At 36 months
time to deterioration (TTD)
TTD will be defined as the time from inclusion in the study to deterioration of EORTC QLQ-C30 score with a decrease ≥5 points at any time point after the baseline score at 6 months and at the end of study.
Time frame: At 36 months
PK-PD evaluation
based on available PopPK modelisation and PK samples collected at the time of the response evaluation in this study
Time frame: At 36 months
Mechanism of EMT
To assess the mechanisms of EMT reversal by comparing different histological markers on pre-therapeutic and Cycle4-Cycle5 biopsies. Descriptive study in transcriptomics and immunohistochemistry of the evolution of EMT markers, the expression of Netrin-1 and its receptors, and tumor microenvironment during treatment by comparing pre-therapeutic biopsies to Cycle4-Cycle5 biopsies
Time frame: At 36 months