Colon CancerPhase 1NCT03827967
Trial of PalloV-CC in Colon Cancer
A Phase 1 study testing PalloV-CC in people with Colon Cancer, run by George E. Peoples at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- PalloV-CC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2019to 20 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Associates of Research Therapeutics of America
San Antonio, Texas, 78212
About this study
Official title: A Phase Ib Trial of Neoadjuvant PalloV-CC (Particle-delivered, Allogeneic Tumor Cell Lysate Vaccine for Colon Cancer) in Colon Cancer
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.
Read the detailed description
This is a single arm, open label, phase Ib trial of neoadjuvant vaccination in colon cancer. The primary endpoint is the safety and toxicity of the vaccine. The primary immunologic endpoint is the impact of vaccination on the tumor microenvironment compared to prospectively evaluated, tissue banked specimens from historical controls. The tumor microenvironment will also be compared in matched pre- and post-treatment tissue samples in vaccinated subjects. Patients with endoscopic biopsy proven colon cancer will be identified by the staff in the gastroenterology, surgery, and/or the hematology/oncology clinics at the individual study sites. A research nurse, study coordinator, or study investigator will approach these patients about being in the trial and will introduce the trial to the prospective volunteer patient. If the patient is interested and appears eligible, the nurse, study coordinator, or investigator will arrange an appointment to counsel and consent the patient. Once consent is obtained, the nurse, study coordinator, or investigator will thoroughly screen the patient for inclusion and exclusion eligibility criteria.
If volunteers meet all inclusion criteria and none of the exclusion criteria and agree to participate, they will continue in the study, consented and enrolled for treatment assignment. Enrollment will start in cohort 1 with enrollment of 6 patients, and follow sequentially into the remaining cohorts, until all cohorts are completed. After treatment of all 6 patients in each dose cohort, a comprehensive safety analysis will be performed for short-term toxicity. If no dose limiting toxicity (DLT, >grade 2, related, or serious adverse event (SAE)) is found, then the next cohort will be enrolled. If three patients in a given dose cohort experience a DLT, then that dose will be determined to be the maximal tolerated dose (MTD), and the next dose cohort will not be initiated. At the completion of dosing of cohorts (last surgical colectomy performed), a comprehensive safety analysis will be performed for long-term toxicity. If the MTD is not reached, then a total of 24 patients will be enrolled.
Treatment cohorts (each n=6, total of n=24):
- 1 x 10^8 particles of PalloV-CC
- 2 x 10^8 particles of PalloV-CC
- 4 x 10^8 particles of PalloV-CC
- 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 (Appendix A), each patient treatment period is 4 weeks (Appendix B). Patients will conclude treatment with colectomy.
Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
A total of 190 mL of blood will be drawn throughout the course of the study over a 3-4 week period. The patient will have 70mL of blood drawn for the following: a CBC with differential (10 mL of blood), a CMP (10 mL of blood), and study blood (50 mL of blood). This will be drawn on two separate occasions: once prior to the first vaccine inoculation, and again after the completion of the final vaccine inoculation (but prior to surgery). An additional 50 mL of study blood will be drawn midway through the vaccine series (at the third inoculation).
- Conditions
- Colon Cancer
- Being tested
- PalloV-CC
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalloV-CCBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 1x10^8 particles of PalloV-CC | Experimental | Intradermal injection of PalloV-CC weekly x 4 weekly Receives: Biological: PalloV-CC |
| 2x10^8 particles of PalloV-CC | Experimental | Intradermal injection of PalloV-CC weekly x 4 weekly Receives: Biological: PalloV-CC |
| 4x10^8 particles of PalloV-CC | Experimental | Intradermal injection of PalloV-CC weekly x 4 weekly Receives: Biological: PalloV-CC |
| 8x10^8 particles of PalloV-CC | Experimental | Intradermal injection of PalloV-CC weekly x 4 weekly Receives: Biological: PalloV-CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary outcomes (4)
Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore
To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the Immunoscore (scale range: low, intermediate, high) between matched endoscopic biopsies (pre-vaccination) and resected final specimens (post-vaccination).
Measured: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment
To determine the concordance of Immunoscore (scale range: low, intermediate, high) with other emerging analytical tools such as gene expression data analysis (CIBERSORT) and T-cell receptor sequencing (Immunoseq).
Measured: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment
Identify PD-L1 expression on tumor cells and compare the pretreatment endoscopic biopsies, post-treatment surgical specimens, and historical controls level of PD-L1 expression.
Measured: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment
Identify CD4+ and regulator T cell infiltration into the tumor microenvironment and compare CD4+ and regulatory T Cell quantity between the pretreatment endoscopic biopsies, post-treatment surgical specimens, and the historical controls.
Measured: 1 year for all 4 cohorts to enroll and undergo treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start20 Jul 2019
- Primary completion19 Apr 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- George E. Peoples
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, George E. Peoples, Cancer Insight, LLC
- Investigators
- George Peoples, MD, FACS, Principal investigator, LumaBridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827967
- Sponsor's protocol ID
- PV-CC-01
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2018
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial of Neoadjuvant PalloV-CC (Particle-delivered, Allogeneic Tumor Cell Lysate Vaccine for Colon Cancer) in Colon Cancer
- ClinicalTrials.gov ID
- NCT03827967
- Acronym / sponsor ID
- PV-CC-01
- Conditions
- Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- George E. PeoplesIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single arm, open label, phase Ib trial of neoadjuvant vaccination in colon cancer. The primary endpoint is the safety and toxicity of the vaccine. The primary immunologic endpoint is the impact of vaccination on the tumor microenvironment compared to prospectively evaluated, tissue banked specimens from historical controls. The tumor microenvironment will also be compared in matched pre- and post-treatment tissue samples in vaccinated subjects. Patients with endoscopic biopsy proven colon cancer will be identified by the staff in the gastroenterology, surgery, and/or the hematology/oncology clinics at the individual study sites. A research nurse, study coordinator, or study investigator will approach these patients about being in the trial and will introduce the trial to the prospective volunteer patient. If the patient is interested and appears eligible, the nurse, study coordinator, or investigator will arrange an appointment to counsel and consent the patient. Once consent is obtained, the nurse, study coordinator, or investigator will thoroughly screen the patient for inclusion and exclusion eligibility criteria.
If volunteers meet all inclusion criteria and none of the exclusion criteria and agree to participate, they will continue in the study, consented and enrolled for treatment assignment. Enrollment will start in cohort 1 with enrollment of 6 patients, and follow sequentially into the remaining cohorts, until all cohorts are completed. After treatment of all 6 patients in each dose cohort, a comprehensive safety analysis will be performed for short-term toxicity. If no dose limiting toxicity (DLT, >grade 2, related, or serious adverse event (SAE)) is found, then the next cohort will be enrolled. If three patients in a given dose cohort experience a DLT, then that dose will be determined to be the maximal tolerated dose (MTD), and the next dose cohort will not be initiated. At the completion of dosing of cohorts (last surgical colectomy performed), a comprehensive safety analysis will be performed for long-term toxicity. If the MTD is not reached, then a total of 24 patients will be enrolled.
Treatment cohorts (each n=6, total of n=24):
- 1 x 10^8 particles of PalloV-CC
- 2 x 10^8 particles of PalloV-CC
- 4 x 10^8 particles of PalloV-CC
- 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 (Appendix A), each patient treatment period is 4 weeks (Appendix B). Patients will conclude treatment with colectomy.
Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
A total of 190 mL of blood will be drawn throughout the course of the study over a 3-4 week period. The patient will have 70mL of blood drawn for the following: a CBC with differential (10 mL of blood), a CMP (10 mL of blood), and study blood (50 mL of blood). This will be drawn on two separate occasions: once prior to the first vaccine inoculation, and again after the completion of the final vaccine inoculation (but prior to surgery). An additional 50 mL of study blood will be drawn midway through the vaccine series (at the third inoculation).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1x10^8 particles of PalloV-CC | Experimental | Biological: PalloV-CCIntradermal injection of PalloV-CC weekly x 4 weekly |
| 2x10^8 particles of PalloV-CC | Experimental | Biological: PalloV-CCIntradermal injection of PalloV-CC weekly x 4 weekly |
| 4x10^8 particles of PalloV-CC | Experimental | Biological: PalloV-CCIntradermal injection of PalloV-CC weekly x 4 weekly |
| 8x10^8 particles of PalloV-CC | Experimental | Biological: PalloV-CCIntradermal injection of PalloV-CC weekly x 4 weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalloV-CCThe 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. | Biological | 1x10^8 particles of PalloV-CC, 2x10^8 particles of PalloV-CC, 4x10^8 particles of PalloV-CC, 8x10^8 particles of PalloV-CC |
Primary outcome
Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
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.
Primary Safety Endpoint-Per Dosing Cohort number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
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.
Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
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.
Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
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).
4 secondary outcomes
Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment
Time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Peoples, MD, FACS principal investigator
LumaBridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PalloV-CC in people with Colon Cancer, run by George E. Peoples at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0. (time frame: 1 year for all 4 cohorts to enroll and undergo treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.