Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03655002
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2018-08-29
Brief Title:
IRX-2 Cyclophosphamide and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase 1b Trial of the IRX-2 Regimen and Nivolumab in Patients With Advanced Hepatocellular Cancer HCC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment Biological therapies such as IRX-2 may stimulate or suppress the immune system in different ways and stop tumor cells from growing Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Immunotherapy with monoclonal antibodies such as nivolumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving IRX-2 cyclophosphamide and nivolumab may work better than the IRX2 regimen alone in treating patients with hepatocellular carcinoma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety profile of combination IRX2 regimen and nivolumab in antiPD1PDL1 naive patients who have failed or not tolerated at least one line of treatment
SECONDARY OBJECTIVES
I To evaluate the overall response rate of IRX2 regimen combined with nivolumab using Response Evaluation Criteria in Solid Tumors RECIST 11 and immune modified RECIST criteria
II To evaluate the rate of 6month progressionfree survival in patients treated with combination IRX2 regimen with nivolumab
III To evaluate median progressionfree survival and overall survival
EXPLORATORY OBJECTIVES
I To evaluate the circulating T cell profiles in patients before and after therapy with the combination IRX2 regimen and nivolumab
II To explore identification of tumor tissue neoantigens through a multiplex proteomic assay MHCPepSeq paired with tumor genomic and transcriptomic sequencing
III To explore putative biomarkers including circulating tumor deoxyribonucleic acid DNA and immune cell profiles in peripheral blood to generate hypotheses for response to treatment with combination IRX2 regimen and nivolumab
OUTLINE This is a dose-escalation study of IRX-2
Patients receive nivolumab intravenously IV over 30 minutes on day 1 cyclophosphamide IV on day 1 and IRX-2 subcutaneously SC for 10 days between days 4 and 15 Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity Patients receive booster IRX-2 SC at 3 6 9 12 and 15 months
After completion of study treatment patients are followed up every 12 weeks
I To determine the safety profile of combination IRX2 regimen and nivolumab in antiPD1PDL1 naive patients who have failed or not tolerated at least one line of treatment
SECONDARY OBJECTIVES
I To evaluate the overall response rate of IRX2 regimen combined with nivolumab using Response Evaluation Criteria in Solid Tumors RECIST 11 and immune modified RECIST criteria
II To evaluate the rate of 6month progressionfree survival in patients treated with combination IRX2 regimen with nivolumab
III To evaluate median progressionfree survival and overall survival
EXPLORATORY OBJECTIVES
I To evaluate the circulating T cell profiles in patients before and after therapy with the combination IRX2 regimen and nivolumab
II To explore identification of tumor tissue neoantigens through a multiplex proteomic assay MHCPepSeq paired with tumor genomic and transcriptomic sequencing
III To explore putative biomarkers including circulating tumor deoxyribonucleic acid DNA and immune cell profiles in peripheral blood to generate hypotheses for response to treatment with combination IRX2 regimen and nivolumab
OUTLINE This is a dose-escalation study of IRX-2
Patients receive nivolumab intravenously IV over 30 minutes on day 1 cyclophosphamide IV on day 1 and IRX-2 subcutaneously SC for 10 days between days 4 and 15 Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity Patients receive booster IRX-2 SC at 3 6 9 12 and 15 months
After completion of study treatment patients are followed up every 12 weeks
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 |
|---|---|---|---|
| NCI-2018-01786 | REGISTRY | None | None |
| 18245 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA033572 |