Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777708
Status:
TERMINATED
Last Update Posted:
2023-03-24
First Post:
2021-02-25
Brief Title:
BO-112 and Pembrolizumab for the Treatment of PD-1PD-L1 Refractory Liver Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Pilot Feasibility Study of Intratumoral BO-112 in Combination With Pembrolizumab for Advanced Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn by sponsor
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This early phase I trial evaluates the side effects of BO-112 and pembrolizumab and how well they work in treating patients with Barcelona Clinic Liver Cancer BCLC stage B or C liver cancer Immunotherapy with BO-112 may induce changes in bodys immune system and may interfere with the ability of tumor cells to grow and spread Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread Giving BO-112 and pembrolizumab may help treat patients with liver cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine the early efficacy and safety for the combination of intratumoral nanoplexed poly IC BO-112 BO-112 in combination with pembrolizumab in patients with advanced hepatocellular carcinoma HCC who have progressed on prior anti-PD-1PD-L1 therapy
SECONDARY OBJECTIVES
I To further elucidate efficacy endpoints of the combination the combination of BO-112 with pembrolizumab
II To demonstrate the efficacy of BO-112 from its hypothesized mechanism of action
CORRELATIVE RESEARCH OBJECTIVES
I Peripheral blood will be collected to assess changes in circulating cluster of differentiation 4 CD4 cluster of differentiation 8 CD8 natural killer NK and dendritic cells
II Peripheral blood will be collected to assess leukocyte expression of interferon beta induced genes in conjunction with intratumoral studies to demonstrate increased intratumoral interferon beta and other hypothesized biomarkers
III A baseline biopsy will be collected on cycle 1 day 1 and at cycle 2 day 15 done at the same time as intratumoral injection
IIIa From these biopsies intratumoral CD4 CD8 expression and cluster of differentiation 56 CD56 expression NK cells will be measured by immunohistochemistry on the baseline biopsy and the biopsy on cycle 2 day 15
IIIb Myeloid dendritic cells will be assessed by flow cytometry as their activity correlates with Toll-like receptor 3 TLR3 activation
IIIc Percentage of cells with apoptosis and necrosis will be assessed IIId The tumor microenvironment will be assessed by ribonucleic acid RNA expression profiling with nCounter Pancancer Immune Profiling Panel given its extensive validation to date
IV To assess the potential of immune-related Response Evaluation Criteria in Solid Tumors RECIST iRECIST to determine disease control as compared to RECIST 11
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of odd number cycles Patients also receive BO-112 by intratumoral injection on day 1 8 and 15 of cycle 1 and day 15 of subsequent cycles Treatment repeats every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days every 8 weeks for 1 year and then every 12 weeks thereafter
I To determine the early efficacy and safety for the combination of intratumoral nanoplexed poly IC BO-112 BO-112 in combination with pembrolizumab in patients with advanced hepatocellular carcinoma HCC who have progressed on prior anti-PD-1PD-L1 therapy
SECONDARY OBJECTIVES
I To further elucidate efficacy endpoints of the combination the combination of BO-112 with pembrolizumab
II To demonstrate the efficacy of BO-112 from its hypothesized mechanism of action
CORRELATIVE RESEARCH OBJECTIVES
I Peripheral blood will be collected to assess changes in circulating cluster of differentiation 4 CD4 cluster of differentiation 8 CD8 natural killer NK and dendritic cells
II Peripheral blood will be collected to assess leukocyte expression of interferon beta induced genes in conjunction with intratumoral studies to demonstrate increased intratumoral interferon beta and other hypothesized biomarkers
III A baseline biopsy will be collected on cycle 1 day 1 and at cycle 2 day 15 done at the same time as intratumoral injection
IIIa From these biopsies intratumoral CD4 CD8 expression and cluster of differentiation 56 CD56 expression NK cells will be measured by immunohistochemistry on the baseline biopsy and the biopsy on cycle 2 day 15
IIIb Myeloid dendritic cells will be assessed by flow cytometry as their activity correlates with Toll-like receptor 3 TLR3 activation
IIIc Percentage of cells with apoptosis and necrosis will be assessed IIId The tumor microenvironment will be assessed by ribonucleic acid RNA expression profiling with nCounter Pancancer Immune Profiling Panel given its extensive validation to date
IV To assess the potential of immune-related Response Evaluation Criteria in Solid Tumors RECIST iRECIST to determine disease control as compared to RECIST 11
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of odd number cycles Patients also receive BO-112 by intratumoral injection on day 1 8 and 15 of cycle 1 and day 15 of subsequent cycles Treatment repeats every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days every 8 weeks for 1 year and then every 12 weeks thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-000276 | OTHER | UCLA Jonsson Comprehensive Cancer Center | None |
| NCI-2021-00994 | REGISTRY | None | None |