Pembrolizumab + Dendritic Cell Therapy for Colorectal Cancer

Overseen by Sarbajit Mukherjee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sarbajit Mukherjee

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with colorectal cancer that hasn't improved with standard treatments. They must have not used PD-1/PD-L1/PD-L2 inhibitors before, have at least two measurable tumors, and be in good physical condition (ECOG 0-1). Participants need functioning major organs and agree to use effective birth control. Those with severe allergies to pembrolizumab, active lung disease, ongoing immunosuppression, or recent other cancer treatments are excluded.

Inclusion Criteria

I will use effective birth control for two years after my last treatment.

I am fully active or can carry out light work.

Platelet >= 75,000/uL

Exclusion Criteria

Has a known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required

I am currently being treated for an infection.

You have had a very strong allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.

Treatment Details

Interventions

• Pembrolizumab (PD-1 Inhibitor)
• Therapeutic Autologous Dendritic Cells (Cancer Vaccine)

Trial Overview The trial tests a combination of pembrolizumab (an immune checkpoint inhibitor) and dendritic cell-based therapy made from the patient's own blood cells. The goal is to see if this combo can shrink colorectal tumors by enhancing the body's immune response against cancer.

Participant Groups

Group I: Treatment (pembrolizumab, autologous dendritic cells) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University