Stage IV Colorectal CancerPhase 2COREVAX-1NCT02919644
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
A Phase 2 study testing autologous dendritic cells loaded with autologous tumour homogenate and IL2 in people with Stage IV Colorectal Cancer and Curative Resection, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
Trial summary
Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stage IV Colorectal Cancer, Curative Resection
- What is being tested?
- autologous dendritic cells loaded with autologous tumour homogenate and IL2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Dec 2016to Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent.
- The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS) and must fulfil all the acceptance criteria prescribed by the Good Manufacturing practise (GMP) procedures.
- The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.
- The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.
- Age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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- Patient must have acceptable organ function, defined as:
- Haemoglobin >10 g/dl
- White blood cells ≥4000/μl.
- Absolute neutrophil count >1500/μl.
- Platelets ≥100000/μl.
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) <3 times the upper institutional reference level.
- Total bilirubin <1.5 times the upper institutional reference level.
- Serum creatinine <1.5 times the upper institutional reference level.
- Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.
- Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of <1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his/her strict compliance with this prescription in the judgement of the Investigator.
- The patient is willing and able to give written informed consent for the study.
Who cannot join
- Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- Patients who relapsed within 6 months since primary treatment of stage I-III colorectal cancer. If adjuvant chemotherapy had been administered, the term must be computed since last chemotherapy dose.
- Patient who completed surgery more than 60 days before study enrolment.
- History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
- Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti-HBs antibodies and anti-hepatitis B core (HBc) antibodies), hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukapheresis). The sole positivity for antibodies against the HBV S antigen (i.e. with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable.
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- Female patients who are pregnant or nursing.
- Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator (e.g. for unacceptable toxicity) or refuse completion of the perioperatory treatment.
- Participation in another clinical trial with any investigational agent within 30 days prior to study screening.
- Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator.
- Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.
- Any clinical condition that, in the opinion of the Investigator, contraindicates the subcutaneous administration of low-dose IL-2 as per protocol (see section 6.2 for details).
- Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations potentially impacting patient safety and compliance in the opinion of the Investigator.
- Refusal of giving written informed consent.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
CRO-IRCCS Aviano
Aviano
UO Immunoterapia e Laboratorio TCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
Meldola, FC, 47014
About this study
Official title: Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer: a Phase II Study
Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer
Read the detailed description
Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study.
Primary objectives: Safety Immunological efficacy, expressed as number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of Colon-Rectal Cancer (CRC)-associated antigens.
Secondary objectives: Clinical outcome of the patients (OS, RFS, TTR). To evaluate the predictive role of the development of a positive DTH test after at least three vaccine administrations.
To evaluate the persistence of an antitumor immune response after the completion of the vaccination program.
To evaluate the prognostic or predictive role of the enhancement of a specific immune response.
To evaluate a panel of inflammatory cytokines involved in antitumor immune response.
To evaluate the predictive role of immune cells in tumour microenvironment. To evaluate the predictive role of tumour antigen expression.
This is a two-stage, phase 2 clinical trial designed according to Simon minimax design. A 40% immune response rate would preclude further studies, while a 70% immune response rate would indicate that further studies would be warranted. Given α and β error of 0.1, the first stage will require enrolment of 7 patients. If at least 3 patients show an immune response and toxicity is acceptable, the study will proceed to the second stage and additional 12 patients will be enrolled.
The vaccine will be considered immunologically active if at least 11 patients are immunological responders.
- Conditions
- Stage IV Colorectal Cancer, Curative Resection
- Being tested
- autologous dendritic cells loaded with autologous tumour homogenate, IL2
- Keywords
- vaccination, autologous dendritic cells, autologous tumour homogenate, curative resection, stage IV colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cells loaded with autologous tumour homogenateBiological
Each vaccine dose consists of 10_7 autologous dendritic cells loaded with autologous tumor homogenate
IL2Drug
Each vaccine dose is followed, after two days, by IL-2 as adjuvant, at a dose of 3 MU daily for five consecutive days
| Study group | Role | What they receive |
|---|---|---|
| vaccine + Interleukin -2 (IL2) | Experimental | autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1), followed by IL-2 given by subcutaneous injection daily for five days (days 3-7) Receives: Biological: autologous dendritic cells loaded with autologous tumour homogenate; Drug: IL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
To characterize the safety of the study drugs all adverse events observed during the study will be collected and assessed using the CTCAE v 4.03 criteria . Type, incidence, and severity of the adverse events will be reported and analyzed using descriptive statistics. All patients who received at least one treatment cycle will be considered evaluable for this primary endpoint.
Measured: up to 24 months
immunological efficacy
Immunological efficacy will be assessed by quantifying circulating immune effectors specific for a selected panel of tumour antigens using interferon (IFN) - γELISPOT analysis . The assay determines the proportion of peptide-reactive T lymphocytes from peripheral blood mononuclear cells (PBMC) expressed as number of spot-forming Cells
Measured: up to 24 months
Secondary outcomes (8)
Relapse Free Survival (RFS)
Relapse Free Survival (RFS) is calculated as the time from study enrolment to either disease recurrence, defined as above, or the date of death for any cause. Patients alive with no evidence of disease recurrence at the time of their last visit are censored at the time of the last examination.
Measured: up to 7 years
Overall Survival (OS)
Overall Survival (OS) is calculated as the time from study enrolment to the date of death for any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.
Measured: up to 7 years
Positive Delayed Type Hypersensitivity (DTH) skin test
evaluation of the predictive role of a positive DTH test after at least three vaccine administrations
Measured: up 24 months
Antitumor Immune response
evaluation of the persistence of an antitumor immune response after the completion of the vaccination program assessed by ELISPOT assays
Measured: up to 7 years
evaluation of the prognostic or predictive role of the enhancement of a specific immune response
evaluation of the prognostic or predictive role of the enhancement of a specific immune response assessed by ELISPOT
Measured: up to 7 years
evaluation of a panel of inflammatory cytokines involved in antitumor immune response
Serum sampling will allow the evaluation of a panel of inflammatory cytokines during and after treatment and their concentration will be evaluated by SearchLight multiplex array analysis according to manufacturer's instructions (FDA-validated test)
Measured: up to 24 months
evaluation of the predictive role of tumour antigen expression
Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to evaluate the expression of tumour-associated antigen
Measured: up to 24 months
evaluation of the predictive role of immune cells in tumor microenvironment
Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to characterize the immune infiltrate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start2 Dec 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Colorectal 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco De Rosa, MD, Principal investigator, UO Immunoterapia e Laboratorio TCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919644
- Sponsor's protocol ID
- IRST153.04
- Other IDs
- 2015-000894-11, 2015
- Acronym
- COREVAX-1
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2016
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer: a Phase II Study
- ClinicalTrials.gov ID
- NCT02919644
- Acronym / sponsor ID
- COREVAX-1 / IRST153.04
- Conditions
- Stage IV Colorectal Cancer, Curative Resection
- Keywords
- vaccination, autologous dendritic cells, autologous tumour homogenate, curative resection, stage IV colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- 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.
Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer
Detailed description
Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study.
Primary objectives: Safety Immunological efficacy, expressed as number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of Colon-Rectal Cancer (CRC)-associated antigens.
Secondary objectives: Clinical outcome of the patients (OS, RFS, TTR). To evaluate the predictive role of the development of a positive DTH test after at least three vaccine administrations.
To evaluate the persistence of an antitumor immune response after the completion of the vaccination program.
To evaluate the prognostic or predictive role of the enhancement of a specific immune response.
To evaluate a panel of inflammatory cytokines involved in antitumor immune response.
To evaluate the predictive role of immune cells in tumour microenvironment. To evaluate the predictive role of tumour antigen expression.
This is a two-stage, phase 2 clinical trial designed according to Simon minimax design. A 40% immune response rate would preclude further studies, while a 70% immune response rate would indicate that further studies would be warranted. Given α and β error of 0.1, the first stage will require enrolment of 7 patients. If at least 3 patients show an immune response and toxicity is acceptable, the study will proceed to the second stage and additional 12 patients will be enrolled.
The vaccine will be considered immunologically active if at least 11 patients are immunological responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine + Interleukin -2 (IL2) | Experimental | Biological: autologous dendritic cells loaded with autologous tumour homogenate, Drug: IL2autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1), followed by IL-2 given by subcutaneous injection daily for five days (days 3-7) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent.
- The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS) and must fulfil all the acceptance criteria prescribed by the Good Manufacturing practise (GMP) procedures.
- The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.
- The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.
- Age >18 years.
Key exclusion criteria (14 listed)
- Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- Patients who relapsed within 6 months since primary treatment of stage I-III colorectal cancer. If adjuvant chemotherapy had been administered, the term must be computed since last chemotherapy dose.
- Patient who completed surgery more than 60 days before study enrolment.
- History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
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 |
|---|---|---|
| autologous dendritic cells loaded with autologous tumour homogenateEach vaccine dose consists of 10_7 autologous dendritic cells loaded with autologous tumor homogenate | Biological | vaccine + Interleukin -2 (IL2) |
| IL2Each vaccine dose is followed, after two days, by IL-2 as adjuvant, at a dose of 3 MU daily for five consecutive days | Drug | vaccine + Interleukin -2 (IL2) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 24 months
To characterize the safety of the study drugs all adverse events observed during the study will be collected and assessed using the CTCAE v 4.03 criteria . Type, incidence, and severity of the adverse events will be reported and analyzed using descriptive statistics. All patients who received at least one treatment cycle will be considered evaluable for this primary endpoint.
immunological efficacy
Time frame: up to 24 months
Immunological efficacy will be assessed by quantifying circulating immune effectors specific for a selected panel of tumour antigens using interferon (IFN) - γELISPOT analysis . The assay determines the proportion of peptide-reactive T lymphocytes from peripheral blood mononuclear cells (PBMC) expressed as number of spot-forming Cells
8 secondary outcomes
Relapse Free Survival (RFS)
Time frame: up to 7 years
Overall Survival (OS)
Time frame: up to 7 years
Positive Delayed Type Hypersensitivity (DTH) skin test
Time frame: up 24 months
Antitumor Immune response
Time frame: up to 7 years
evaluation of the prognostic or predictive role of the enhancement of a specific immune response
Time frame: up to 7 years
evaluation of a panel of inflammatory cytokines involved in antitumor immune response
Time frame: up to 24 months
evaluation of the predictive role of tumour antigen expression
Time frame: up to 24 months
evaluation of the predictive role of immune cells in tumor microenvironment
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Francesco De Rosa, MD principal investigator
UO Immunoterapia e Laboratorio TCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous dendritic cells loaded with autologous tumour homogenate and IL2 in people with Stage IV Colorectal Cancer and Curative Resection, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
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 17 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: up to 24 months). 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?
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 28 Oct 2026.