Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-28 @ 12:51 PM
Study NCT ID:
NCT05518032
Status:
WITHDRAWN
Last Update Posted:
2024-09-26
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Phase 2 Study of Intravenous Pembrolizumab and Intratumorally Injected Autologous Dendritic Cells (DCs) in Refractory Colorectal Cancer (CRC)
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prioritization of studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The phase II trial tests whether pembrolizumab and dendritic cell-based treatment works to shrink tumors in patients with colorectal cancer that does not respond to treatment (refractory). Pembrolizumab, also referred to as an immune checkpoint inhibitor drug, works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either (1) blocking inhibitory molecules or by (2) activating stimulatory molecules. Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. This investigational treatment targets cancer cells and is made from the patient's own blood cells. Giving pembrolizumab and dendritic cell-based treatment may help shrink tumors in patients with colorectal cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the clinical efficacy of pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs) in refractory metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs) in CRC patients.
II. To assess progression-free survival (PFS) in CRC patients receiving pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs).
III. To assess overall survival (OS) in CRC patients receiving pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs).
IV. To assess objective response as determined by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST).
EXPLORATORY OBJECTIVES:
I. To conduct correlative science studies including:
Ia. Comparison of the metastatic tissue specimen with regard to total numbers of infiltrating T cells, their CD4/CD8 ratios, frequencies of Tregs, and their expression of chemokine receptors.
Ib. Evaluate the local expression of T eff-attracting chemokines and T reg-favoring chemokines using immunofluorescence (IF) and reverse transcription-polymerase chain reaction (RT-PCR).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) on days 8, 29, 50, and 71, and autologous dendritic cells intratumorally on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients may also receive an autologous dendritic cells intratumorally on day 50.
After completion study treatment, patients are followed up at 30 and 90 days, and then every 3 months for 12 months.
I. To determine the clinical efficacy of pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs) in refractory metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs) in CRC patients.
II. To assess progression-free survival (PFS) in CRC patients receiving pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs).
III. To assess overall survival (OS) in CRC patients receiving pembrolizumab in combination with intratumorally injected autologous dendritic cells (DCs).
IV. To assess objective response as determined by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST).
EXPLORATORY OBJECTIVES:
I. To conduct correlative science studies including:
Ia. Comparison of the metastatic tissue specimen with regard to total numbers of infiltrating T cells, their CD4/CD8 ratios, frequencies of Tregs, and their expression of chemokine receptors.
Ib. Evaluate the local expression of T eff-attracting chemokines and T reg-favoring chemokines using immunofluorescence (IF) and reverse transcription-polymerase chain reaction (RT-PCR).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) on days 8, 29, 50, and 71, and autologous dendritic cells intratumorally on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients may also receive an autologous dendritic cells intratumorally on day 50.
After completion study treatment, patients are followed up at 30 and 90 days, and then every 3 months for 12 months.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: