Colorectal CancerPhase 1NCT03730948

DC Vaccine in Colorectal Cancer

A Phase 1 study testing DC vaccine in people with Colorectal Cancer, run by University of Pennsylvania at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: DC vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2019to 1 Dec 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)
Surgically resected disease
Male or female patients 18+ years of age
ECOG performance status 0-1
Certain laboratory values, performed within 14 days prior to consent
Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
Provide written informed consent

Who cannot join

Prior malignancy within 3 years that may put subject at risk
Pregnant or nursing women
Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
Known allergy to eggs
Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Read the detailed description

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutated peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease progression.

Conditions: Colorectal Cancer
Being tested: DC vaccine
Keywords: colorectal cancer, cancer vaccine, dendritic cell vaccine
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DC vaccineBiological
DC vaccine for colorectal cancer

Study groups in NCT03730948
Study group	Role	What they receive
All subjects	Experimental	All subjects will receive the vaccine and be followed per the schedule of procedures. Receives: Biological: DC vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response)
Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study.
Measured: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)
Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section.
Measured: Through study completion (at 12 months)

Secondary outcomes (1)

Percentage of CD8+ Cells in Primary Tumor Tissue
Descriptive models
Measured: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 20191 Dec 2022

First posted5 Nov 2018
Study start12 Mar 2019
Primary completion22 Feb 2022
Study completion1 Dec 2022

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03730948
Sponsor's protocol ID: UPCC 16218, 831453
Other IDs: R01CA204261
Status last verified: Apr 2024
First submitted: 30 Oct 2018
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Mature Dendritic Cell Vaccination for Resected Hypermutated Colorectal Cancer
ClinicalTrials.gov ID: NCT03730948
Acronym / sponsor ID: UPCC 16218, 831453
Conditions: Colorectal Cancer
Keywords: colorectal cancer, cancer vaccine, dendritic cell vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of enrollment
Enrolment: 4 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Parker Institute for Cancer Immunotherapy, National Cancer Institute (NCI)
Study start: 12 Mar 2019 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 5 Nov 2018 (actual)
Results: Posted 24 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Detailed description

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects	Experimental	Biological: DC vaccineAll subjects will receive the vaccine and be followed per the schedule of procedures.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)
Surgically resected disease
Male or female patients 18+ years of age
ECOG performance status 0-1
Certain laboratory values, performed within 14 days prior to consent

Key exclusion criteria (5 listed)

Prior malignancy within 3 years that may put subject at risk
Pregnant or nursing women
Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
Known allergy to eggs
Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk

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
DC vaccineDC vaccine for colorectal cancer	Biological	All subjects

Primary outcome

Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response)
Time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.
Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study.
Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)
Time frame: Through study completion (at 12 months)
Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section.

1 secondary outcome

Percentage of CD8+ Cells in Primary Tumor Tissue
Time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

Results and safety

Results posted to the registry on 24 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	4	2

Primary outcome: Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response)

Time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.. Number. Unit: IFN-G producing cells / 5x10^5 cells

Measure	Subject 01, Antigen TBCC1D23 K632X n = 1	Subject 01, Antigen CDC7 L28X n = 1	Subject 01, Antigen MSH3 K381X n = 1	Subject 01, Antigen NKTR 613-614X n = 1	Subject 01, Antigen DDX51 P492L n = 1	Subject 01, Antigen APC A885X n = 1	Subject 01, Antigen MAP3K21 A767V n = 1	Subject 01, Antigen DAG1 W31R n = 1	Subject 01, Antigen ZC3H18 A886V n = 1	Subject 01, Antigen PRR11 K20X n = 1	Subject 01, Antigen MSH6 Q657H n = 1	Subject 02, Antigen DOCK3 T1850X n = 1	Subject 02, Antigen FAM214BA42X n = 1	Subject 02, Antigen FHDC1F100X n = 1	Subject 02, Antigen DOCK1E1616X n = 1	Subject 02, Antigen PLA2G6 S359L n = 1	Subject 02, Antigen POLG2K160E n = 1	Subject 02, Antigen LYSMD3 V111A n = 1	Subject 02, Antigen FARR459H n = 1	Subject 02, Antigen PDHXI190L n = 1	Subject 02, Antigen FNIP2 K575E n = 1	Subject 02, Antigen ARID1AG284X n = 1	Subject 02, Antigen ACVR2AK435X n = 1
Screening	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Day 1	0	1	33	0	27	36	0	0	1339	0	0	0	0	0	0	0	0	5	0	9	0	15	9
Day 43 (week 6)	201	0	234	312	65	240	0	0	650	5	17	5	0	43	0	34	0	0	0	289	75	0	618
Day 85 (week 12)	0	0	253	167	55	280	0	85	331	10	0	12	0	5	8	5	0	38	8	500	255	0	237
7-14 days after last vaccine (week 14)	53	0	286	13	306	352	0	9	432	10	3	5	4	19	10	5	2	2	29	414	491	0	80
30 days after last vaccine	325	0	1159	0	461	697	34	43	1250	0	0	0	0	0	0	0	0	1	0	789	453	20	2

Population analysed: Results are reported as IFN-G producing cells / 5x10\^5 cells, all CD3+ T cells. Neither subject was tested at 6 months, 9 months, or 12 months time points.

Primary outcome: Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)

Time frame: Through study completion (at 12 months). Number. Unit: participants

Measure	All Subjects n = 3
Value	3

Population analysed: The number of participants includes 1 subject who began the study but did not complete it.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study completion (at 12 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Kim Reiss-Binder, MD principal investigator

University of Pennsylvania

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 DC vaccine in people with Colorectal Cancer, run by University of Pennsylvania 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 May 2024. 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?

Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response) (time frame: Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730948.

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 24 May 2024.