Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575725
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Botensilimab Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Botensilimab Balstilimab and Regorafenib in Patients With Microsatellite Stable Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 II trial studies how well the combination of botensilimab balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced or that has spread from where it first started primary site to other places in the body metastatic Immunotherapy with monoclonal antibodies such as botensilimab and balstilimab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Regorafenib is in a class of medications called kinase inhibitors It works by blocking the action of an abnormal protein that signals tumor cells to multiply This helps to slow or stop the spread of tumor cells The combination of botensilimab balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer
Detailed Description:
COPRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D of botensilimab balstilimab and regorafenib BBR in microsatellite stable MSS metastatic colorectal cancer mCRC patients without metastatic liver lesions in the safety run-in Safety lead-in II Compare the overall response rate in microsatellite stable MSS metastatic colorectal cancer mCRC patients without metastatic liver lesions receiving botensilimab balstilimab and regorafenib BBR versus botensilimab and balstilimab BB by treatment arm Phase II
SECONDARY OBJECTIVES
I Estimate the overall survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB by treatment arm
II Estimate the progression free survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB by treatment arm
III Estimate the duration of response DOR in MSS mCRC patients without metastatic liver lesions receiving BBR and BB that experience a response to therapy by treatment arm
IV Describe the safety of giving to BBR and BB to patients with MSS mCRC without metastatic liver lesions by treatment arm
EXPLORATORY OBJECTIVE
I Through the performance of baseline and on treatment biopsies and serial blood work cytokines and flow cytometry explore potential biomarkers of response to BBR and BB therapy given to MSS mCRC patients without metastatic liver lesions by treatment arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM BBR Patients receive botensilimab intravenously IV over 60 minutes on day 1 of each cycle balstilimab IV over 30 minutes on days 1 15 and 29 of each cycle and regorafenib orally PO once daily QD on days 1-7 15-21 and 29-35 of each cycle or on days 1-5 15-19 and 29-33 of each cycle Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab and regorafenib in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the trial Patients also undergo tumor biopsy during screening and on study
ARM BB Patients receive botensilimab IV over 60 minutes on day 1 of each cycle and balstilimab IV over 30 minutes on days 1 15 and 29 of each cycle Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab in the absence of disease progression or unacceptable toxicity Patients also undergo CT or MRI and blood sample collection throughout the trial Patients also undergo tumor biopsy during screening and on study
After completion of study treatment patients are followed up at 30 and 90 days and then every 2-3 months for 5 years
I Determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D of botensilimab balstilimab and regorafenib BBR in microsatellite stable MSS metastatic colorectal cancer mCRC patients without metastatic liver lesions in the safety run-in Safety lead-in II Compare the overall response rate in microsatellite stable MSS metastatic colorectal cancer mCRC patients without metastatic liver lesions receiving botensilimab balstilimab and regorafenib BBR versus botensilimab and balstilimab BB by treatment arm Phase II
SECONDARY OBJECTIVES
I Estimate the overall survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB by treatment arm
II Estimate the progression free survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB by treatment arm
III Estimate the duration of response DOR in MSS mCRC patients without metastatic liver lesions receiving BBR and BB that experience a response to therapy by treatment arm
IV Describe the safety of giving to BBR and BB to patients with MSS mCRC without metastatic liver lesions by treatment arm
EXPLORATORY OBJECTIVE
I Through the performance of baseline and on treatment biopsies and serial blood work cytokines and flow cytometry explore potential biomarkers of response to BBR and BB therapy given to MSS mCRC patients without metastatic liver lesions by treatment arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM BBR Patients receive botensilimab intravenously IV over 60 minutes on day 1 of each cycle balstilimab IV over 30 minutes on days 1 15 and 29 of each cycle and regorafenib orally PO once daily QD on days 1-7 15-21 and 29-35 of each cycle or on days 1-5 15-19 and 29-33 of each cycle Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab and regorafenib in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the trial Patients also undergo tumor biopsy during screening and on study
ARM BB Patients receive botensilimab IV over 60 minutes on day 1 of each cycle and balstilimab IV over 30 minutes on days 1 15 and 29 of each cycle Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab in the absence of disease progression or unacceptable toxicity Patients also undergo CT or MRI and blood sample collection throughout the trial Patients also undergo tumor biopsy during screening and on study
After completion of study treatment patients are followed up at 30 and 90 days and then every 2-3 months for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None