Trial of PalloV-CC in Colon Cancer

NCT03827967 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PV-CC-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase Ib prospective, open label study evaluating the effect of vaccination on the immune microenvironment of cancers with results compared to banked tissue from historical controls. Prospectively vaccinated patients will also serve as their own controls by comparing the immune microenvironment of the tumor in pre-treatment biopsies to post-treatment surgical specimens. This is also a dose-escalation study with consecutive enrollment and advancement of cohorts in an overlapping fashion.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (4)

• Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  To determine the overall safety and toxicity of the PalloV CC vaccine by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  1 year for all 4 cohorts to enroll and undergo treatment.

• Primary Safety Endpoint-Per Dosing Cohort number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  To determine the safety and toxicity of the PalloV CC vaccine per dosing cohorts by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  1 year for all 4 cohorts to enroll and undergo treatment.

• Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment

  To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects with high Immunoscore (scale range: low, intermediate, high) in all vaccinated subjects to historical control subjects.

  1 year for all 4 cohorts to enroll and undergo treatment.

• Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment

  To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects Immunoscore (scale range: low, intermediate, high) in vaccinated subjects per dosing cohorts to historical control subjects Immunoscore (scale range: low, intermediate, high).

  1 year for all 4 cohorts to enroll and undergo treatment.

Secondary Outcomes (4)

• Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore

  1 year for all 4 cohorts to enroll and undergo treatment.

• Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment

  1 year for all 4 cohorts to enroll and undergo treatment.

• Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment

  1 year for all 4 cohorts to enroll and undergo treatment.

• Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment

  1 year for all 4 cohorts to enroll and undergo treatment.

Study Arms (4)

1x10^8 particles of PalloV-CC

EXPERIMENTAL

Intradermal injection of PalloV-CC weekly x 4 weekly

Biological: PalloV-CC

2x10^8 particles of PalloV-CC

EXPERIMENTAL

Intradermal injection of PalloV-CC weekly x 4 weekly

Biological: PalloV-CC

4x10^8 particles of PalloV-CC

EXPERIMENTAL

Intradermal injection of PalloV-CC weekly x 4 weekly

Biological: PalloV-CC

8x10^8 particles of PalloV-CC

EXPERIMENTAL

Intradermal injection of PalloV-CC weekly x 4 weekly

Biological: PalloV-CC

Interventions

PalloV-CC BIOLOGICAL

The PalloV-CC vaccine uses yeast cell wall particles (YCWP) to serve as an efficient vaccine delivery system as they can contain a broad range of antigenic material, they are rapidly phagocytized by antigen presenting cells, and they are inherently immunogenic. The PalloV-CC vaccine utilizes silicate-capped YCWP to deliver allogenic colon cancer tumor lysate. The vaccine will be given to subjects with resectable colon cancers neoadjuvantly shortly before surgery in order to study the effect of the vaccine on the tumor microenvironment using a well-validated immune scoring system for colon cancer and other immunologic tests.

1x10^8 particles of PalloV-CC; 2x10^8 particles of PalloV-CC; 4x10^8 particles of PalloV-CC; 8x10^8 particles of PalloV-CC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I-IV (resectable) colon cancer patients identified prior to their definitive surgery
• Diagnosis definitively confirmed by endoscopic biopsy with tumor tissue slides available for analysis
• Asymptomatic and capable of waiting 4 weeks prior to definitive surgery
• ECOG 0-1 performance
• Not involved in other clinical trials
• Capable of giving informed consent

You may not qualify if:

• Symptoms of obstruction or GI bleeding that necessitate more urgent surgical intervention
• Cancer not definitively confirmed on endoscopic biopsy (i.e., Only high-grade dysplasia or adenoma identified, even if malignancy is suspected)
• Known immune deficiency disease or HIV, active HBV, or active HCV
• Steroids or other immunosuppressants received within 6 weeks of enrollment
• Any colon cancer directed treatment (chemotherapy or radiation) received or planned prior to surgical resection
• A history of any hematologic malignancy or myeloproliferative disease within 5 years prior to enrollment
• Leukopenia or neutropenia within two weeks of presentation
• ECOG \>/= 2
• Pregnancy (serum or urine HCG) or breast feeding
• Tbili \>1.8, Cr \>2, Hgb \<10, platelet count \<50,000, WBC \<2,000

Sponsors & Collaborators

• George E. Peoples: lead

Study Sites (1)

Clinical Associates of Research Therapeutics of America

San Antonio, Texas, 78212, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• George Peoples, MD, FACS

  LumaBridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO, Cancer Insight, LLC

Model Details: Treatment cohorts (each n=6 total of n=24): 1. 1 x 10\^8 particles of PalloV-CC 2. 2 x 10\^8 particles of PalloV-CC 3. 4 x 10\^8 particles of PalloV-CC 4. 8 x 10\^8 particles of PalloV-CC PalloV-CC is inoculated weekly via intradermal injection. There will be sequential enrollment of dose-escalation cohorts, each patient treatment period is 4 weeks. Patients will conclude treatment with colectomy.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: February 4, 2019
• Study Start: July 20, 2019
• Primary Completion: April 19, 2023
• Study Completion: May 20, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)