Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320405
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-05
Brief Title:
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase IbII Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial tests the safety side effects and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor 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 Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread Immunotherapy with monoclonal antibodies such as retifanlimab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Paclitaxel is in a class of medications called antimicrotubule agents It stops cancer cells from growing and dividing and may kill them Giving axatilimab in combination with retifanlimab and paclitaxel may be safe tolerable andor effective in treating patients with advanced or metastatic solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I Phase Ib Determine the safety and tolerability of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors
II Phase II Determine the efficacy of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors
SECONDARY OBJECTIVES
I Determine the safety and tolerability of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors treated in phase II
II Explore treatment related changes in the tumor microenvironment TME following treatment with the combination of axatilimab retifanlimab and paclitaxel in advanced solid tumors
III Assess predictive biomarkers of response in peripheral blood
OUTLINE
Patients receive axatilimab intravenously IV over 30 minutes on day -8 prior to cycle 1 Beginning in cycle 1 day 1 patients receive axatilimab IV over 30 minutes on days 8 and 21 of each cycle retifanlimab IV over 30-60 minutes on day 1 of each cycle and paclitaxel IV over 60 minutes on days 1 8 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo tumor biopsy computed tomography CT scan and blood sample collection at screening and on study and may undergo magnetic resonance imaging MRI andor positron emission tomography PET scan at screening and on study
After completion of study treatment patients are followed up at 30 and 90 days
I Phase Ib Determine the safety and tolerability of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors
II Phase II Determine the efficacy of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors
SECONDARY OBJECTIVES
I Determine the safety and tolerability of the combination of axatilimab retifanlimab and paclitaxel in patients with advanced solid tumors treated in phase II
II Explore treatment related changes in the tumor microenvironment TME following treatment with the combination of axatilimab retifanlimab and paclitaxel in advanced solid tumors
III Assess predictive biomarkers of response in peripheral blood
OUTLINE
Patients receive axatilimab intravenously IV over 30 minutes on day -8 prior to cycle 1 Beginning in cycle 1 day 1 patients receive axatilimab IV over 30 minutes on days 8 and 21 of each cycle retifanlimab IV over 30-60 minutes on day 1 of each cycle and paclitaxel IV over 60 minutes on days 1 8 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo tumor biopsy computed tomography CT scan and blood sample collection at screening and on study and may undergo magnetic resonance imaging MRI andor positron emission tomography PET scan at screening and on study
After completion of study treatment patients are followed up at 30 and 90 days
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01397 | REGISTRY | None | None |
| STUDY00025940 | OTHER | OHSU Knight Cancer Institute | None |