Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT05518032
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Recurrent Colorectal Carcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Unresectable Colorectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Therapeutic Autologous Dendritic Cells — BIOLOGICAL
    Given intratumorally

Study Details

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.

Key Dates

First listed
Aug 26, 2022
Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, autologous dendritic cells)
    Patients receive pembrolizumab 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.

Primary Outcome Measure

Objective response rate [ Time Frame: At 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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