Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399419
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-01
Brief Title:
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
Sponsor:
Osel Inc
Organization:
Osel Inc
Study Overview
Official Title:
An Open-Label Phase I Dose-Finding Study of CBM588 in Combination With NivolumabIpilimumab for Patients With Advanced Stage Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
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 I trial tests the safety side effects best dose and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the bodys immune cells to attack tumor cells CBM588 in combination with nivolumab and ipilimumab may be safe tolerable andor effective in treating patients with advanced stage kidney cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the safety and tolerability of nivolumabipilimumab with escalating doses of Clostridium butyricum MIYAIRI 588 capsules CBM588 in patients with metastatic renal cell carcinoma
SECONDARY OBJECTIVES
I To evaluate the effect of CBM588 on the clinical efficacy of nivolumabipilimumab
II To determine the effect of CBM588 in combination with nivolumabipilimumab in modulation of the gut microbiome in patients with metastatic renal cell carcinoma
III To assess the effect of CBM588 on the change of metabolic pathways with the nivolumabipilimumab combination in patients with metastatic renal cell carcinoma
IV To determine the effect of CBM588 on systemic immunomodulation
OUTLINE This is a dose-escalation study of CBM588 followed by a dose-expansion study
Patients receive CBM588 capsules orally PO twice daily BID on days 1-21 nivolumab intravenously IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 4 cycles Patients then receive CBM588 PO BID on days 1-28 and nivolumab IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo computed tomography CT bone scan and blood sample collection throughout the study Patients may optionally undergo magnetic resonance imaging MRI on study
After completion of study treatment patients are followed up once a year
I To evaluate the safety and tolerability of nivolumabipilimumab with escalating doses of Clostridium butyricum MIYAIRI 588 capsules CBM588 in patients with metastatic renal cell carcinoma
SECONDARY OBJECTIVES
I To evaluate the effect of CBM588 on the clinical efficacy of nivolumabipilimumab
II To determine the effect of CBM588 in combination with nivolumabipilimumab in modulation of the gut microbiome in patients with metastatic renal cell carcinoma
III To assess the effect of CBM588 on the change of metabolic pathways with the nivolumabipilimumab combination in patients with metastatic renal cell carcinoma
IV To determine the effect of CBM588 on systemic immunomodulation
OUTLINE This is a dose-escalation study of CBM588 followed by a dose-expansion study
Patients receive CBM588 capsules orally PO twice daily BID on days 1-21 nivolumab intravenously IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 4 cycles Patients then receive CBM588 PO BID on days 1-28 and nivolumab IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo computed tomography CT bone scan and blood sample collection throughout the study Patients may optionally undergo magnetic resonance imaging MRI on study
After completion of study treatment patients are followed up once a year
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-2024-03079 | REGISTRY | None | None |
| 23554 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA033572 |