Colorectal Cancer MetastaticPhase 2CombiCoR-VaxNCT06522919
Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer
A Phase 2 study testing Autologous Dendritic Cell (DC) Vaccine in people with Colorectal Cancer Metastatic and Microsatellite Stable Colorectal Carcinoma, 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, open-label, multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Microsatellite Stable Colorectal Carcinoma, Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
- What is being tested?
- Autologous Dendritic Cell (DC) Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Jan 2025to 1 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent.
- Histologically confirmed pMMR or MSS mCRC
- Male or female, aged ≥ 18 years
- Life expectancy greater than 12 weeks
- ECOG performance status <2
- Patient suitable for the collection of biological material from leukapheresis: negative serological tests (HIV, HBV, HCV, Treponema pallidum); normal cardiological parameters (12-lead ECG and echocardiogram); evaluation by transfusionist to exclude possible contraindications to leukapheresis; recovered (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous treatments.Exclusion Criteria:
Show all 14Show fewer
- Patients must have measurable disease by RECIST v 1.1 criteria on CT (or MRI) scan of the chest, abdomen and pelvis. See section 9.2 and Appendix D for the evaluation of measurable disease.
- Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or anti-EGFR monoclonal antibody for RAS wild-type tumors.
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/μL, absolute neutrophil count >1,500/μL, platelets >100,000/μL, total bilirubin < 1.5 X institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) <2.5 X ULN, creatinine < 1.5 X ULN OR creatinine clearance >30 mL/min/1.73 m2
- The autologous surgical specimen needed for vaccine manufacturing must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and must fulfill all the acceptance criteria prescribed by the GMP procedures
- Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.
- A female participant is eligible to participate if she is not pregnant and not breastfeeding. Female patients of childbearing potential and all male patients must accept and be compliant with a highly effective contraceptive method
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Prior treatment with FTD/TPI for mCRC
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab, FTD/TPI, Bevacizumab or components of the DC vaccine.
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- History of congenital or acquired immunodeficiency, including history of organ transplantation.
- Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Meldola, Forlì Cesena, 47014
Oriana Nanni, +390543739266, oriana.nanni@irst.emr.it
Bernadette Vertogen, +390544286058, bernadette.vertogen@irst.emr.it
- Not yet recruiting
Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card.G.Panico"
Tricase, Lecce, 73039
Emiliano Tamburini, MD, +390833773111, e.tamburini@piafondazionepanico.it
About this study
Official title: Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil (FTD/TPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)
Single-arm, open-label, multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR metastatic colorectal cancer.
Read the detailed description
Metastatic colorectal cancer (mCRC) remains an incurable disease characterized by a poor prognosis. Recently, in the global phase 3 SUNLIGHT (NCT04737187) study, adding Bevacizumab to Trifluridine/Tipiracil (FTD/TPI) in the treatment of refractory mCRC significantly improved overall survival. Therefore, this combination regimen is going to become the new standard of care for refractory mCRC. Immune checkpoint inhibitors (ICIs), including Pembrolizumab, have shown excellent results in MSI-H or dMMR mCRC, and recent trials evaluating both concomitant and sequential chemoimmunotherapy in MSS/pMMR mCRC (in particular ATEZOTRIBE and MAYA trials), have shown promising results. Since 2001, we have treated more than 80 advanced melanoma patients with a tumor lysate loaded autologous DC vaccine, observing a clinical benefit of 54.1% and, more importantly, an ORR of 63.6% to subsequent chemotherapy, suggesting that immunotherapy might improve the activity of sequential chemotherapy. Moreover, our team has recently concluded the first step of 2 ongoing clinical studies with DC vaccine administration, in radically resected mCRC and metastatic mesothelioma patients - showing that the vaccine was safe and promoted immunological responses that allowed it to continue with patients enrollment.
- Conditions
- Colorectal Cancer Metastatic, Microsatellite Stable Colorectal Carcinoma, Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
- Being tested
- Autologous Dendritic Cell (DC) 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.
Autologous Dendritic Cell (DC) VaccineBiological
Induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR metastatic colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Sequential immunochemotherapy with Pembrolizumab plus DC Vaccine, followed by FTD/TPI + Bevacizumab | Experimental | Induction phase: In the immunological induction phase patients will be given DCs intradermally every week for up to 4 doses and then a further administration after 3 weeks and Pembrolizumab 200 mg IV q3w for up to 3 cycle.
Maintenance phase: patients will receive FTD/TPI combined with Bevacizumab.Treatment with FTD/TPI and Bevacizumab will start regardless of the response obtained with the induction combo immunotherapy, and will continue until confirmed disease progression, unacceptable toxicity or withdrawal of the consent by the patient, whichever occurs first. Receives: Biological: Autologous Dendritic Cell (DC) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The primary endpoint is Overall Response Rate (ORR) of chemotherapy, defined as the percentage of patients experiencing partial response (PR) or complete response (CR), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, after starting the treatment with FTD/TPI plus Bevacizumab.
Measured: 2 years
Secondary outcomes (12)
Progression free survival (PFS)
Measured as the time from the start of the treatment with FTD/TPI plus Bevacizumab to the date of first progression, or the date of death from any cause, or the date of the last restaging in non-progressed patients
Measured: 2 years
Safety evaluation
All adverse events will be recorded during the observation period (i.e. from the day of the first DC vaccine dose administered in the induction phase up to 30 days after the last dose of chemotherapy), will be reported and graded according to NCI CTCAE 5.0.
Measured: 2 years
Overall Survival (OS)
Measured from the start of the induction treatment until the date of death from any cause or the last date on which it was known that the patient was alive.
Measured: 2 years
In vivo immunomonitoring through DTH test:
In vivo immunomonitoring through DTH test: DTH testing will be performed in all patients on day 0 (pre-treatment DTH), after the induction phase (post-combo immuno treatment DTH), after the maintenance phase, at the end of treatment and at disease progression. The diameter of induration/erythema observed after 24 hours is recorded according to the following scale: 0-5 mm grade 1, 6-10 mm grade 2, 11-20 mm grade 3, and > 21 mm grade 4. As DTH reactivity to lower concentrations of the antigen(s) is strictly related to more intense antigen specific immune responses, score results will be normalized against the concentration itself and transformed into a 0-80 scale for analysis purposes. Best results obtained for each patient at any of the posttreatment DTHs, either for tumor homogenate or keyhole limpet hemocyanin (KLH), will be taken into account for data analysis (best normalized score).
Measured: 2 years
Characterization of patient's HLA class I immune response
The typing of the locus A-B-C-DR and DQA/DQB will be performed by the Genetic Laboratory by means of the sequence-specific oligonucleotide probe reverse hybridization (PCR-SSO) method. This information will be used to design patient's HLA restricted peptides for personalized functional in vitro immune assays (such as IFN-γ ELISPOT assay and INF-γ secretion assay), as well as for tetramer-guided peripheral monitoring of the antigen specific response. Moreover, statistical analysis will be conducted to correlate the strength of the recorded immunological response to the full HLA haplotype and the clinical outcome.
Measured: 2 years
Characterization of patient's HLA class II immune response
The typing of the locus A-B-C-DR and DQA/DQB will be performed by the Genetic Laboratory by means of the sequence-specific oligonucleotide probe reverse hybridization (PCR-SSO) method. This information will be used to design patient's HLA restricted peptides for personalized functional in vitro immune assays (such as IFN-γ ELISPOT assay and INF-γ secretion assay), as well as for tetramer-guided peripheral monitoring of the antigen specific response. Moreover, statistical analysis will be conducted to correlate the strength of the recorded immunological response to the full HLA haplotype and the clinical outcome.
Measured: 2 years
Characterization of patient's HLA-restricted immune response
The typing of the locus A-B-C-DR and DQA/DQB will be performed by the Genetic Laboratory by means of the sequence-specific oligonucleotide probe reverse hybridization (PCR-SSO) method. This information will be used to design patient's HLA restricted peptides for personalized functional in vitro immune assays (such as IFN-γ ELISPOT assay and INF-γ secretion assay), as well as for tetramer-guided peripheral monitoring of the antigen specific response. Moreover, statistical analysis will be conducted to correlate the strength of the recorded immunological response to the full HLA haplotype and the clinical outcome.
Measured: 2 years
Definition of the prognostic and predictive role of peripheral immune cell subsets and soluble factors
Definition of the prognostic and predictive role of peripheral immune cell subsets and soluble factors: PBMC samples taken before treatment, during and after treatment will be evaluated by multiparametric flow cytometry to assess abundance of regulatory cell subsets (regulatory T cells and immunosuppressive myeloid cells). Moreover, an automated platform of multianalyte will be applied in longitudinal plasma samples. Results will be analyzed by means of bioinformatics and statistical tools and correlated with all the relevant clinical parameters.
Measured: 2 years
In situ characterization of pMMR mCRC through Next Generation Sequencing analysis
NGS approaches (WES and RNAseq analysis) together with in house available bioinformatics pipeline will be used to score the antigen/neoantigen expression in pre-treatment and, whenever available, post-treatment tissue. Deconvolution methods will be used to enumerate immune cells abundance from transcriptional data. Moreover, expression of other TME-related transcripts will be addressed and correlated to the clinical outcome.
Measured: 2 years
In situ characterization of MSS mCRC through Next Generation Sequencing analysis
NGS approaches (WES and RNAseq analysis) together with in house available bioinformatics pipeline will be used to score the antigen/neoantigen expression in pre-treatment and, whenever available, post-treatment tissue. Deconvolution methods will be used to enumerate immune cells abundance from transcriptional data. Moreover, expression of other TME-related transcripts will be addressed and correlated to the clinical outcome.
Measured: 2 years
In situ protein validation at the single cell level
In situ protein validation at the single cell level: using an in-house-developed multiplex immunohistochemistry (IHC), well-known mCRC antigens (i.e. survivin, EGFR, p53, MUC-1, mesothelin) will be monitored at the tissue level.
Measured: 2 years
Identification of tumor infiltrating immune cell subsets
Tumor infiltrating immune cell subsets will be identified and quantified (i.e. positive cell score and close proximity score). Moreover, the predictive effect of the frequency and the distribution of infiltrating immune cell subsets will be correlated with the patient's clinical outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start7 Jan 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Model description
- Single-arm, open-label, multicenter phase 2 clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
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
- Alessandro Passardi, Principal investigator, IRCCS IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522919
- Sponsor's protocol ID
- IRST153.09
- Acronym
- CombiCoR-Vax
- Status last verified
- Jan 2025
- First submitted
- 9 Jul 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Passardi A, Sullo FG, Bittoni A, Matteucci L, De Rosa F, Bulgarelli J, Tazzari M, Petrini M, Scarpi E, Testoni S, Miserocchi A, Tartagni O, Zani C, Iaia ML, Toma I, Viola MG, Mita MT, Tamburini E, Ridolfi L. CombiCoR-Vax trial: study protocol for a phase II, single-arm, multicenter trial of sequential pembrolizumab plus dendritic cell vaccine followed by trifluridine/tipiracil and bevacizumab in refractory microsatellite-stable metastatic colorectal cancer. BMC Cancer. 2025 Nov 22;25(1):1921. doi: 10.1186/s12885-025-15371-7.
PubMed 41275134
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil (FTD/TPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)
- ClinicalTrials.gov ID
- NCT06522919
- Acronym / sponsor ID
- CombiCoR-Vax / IRST153.09
- Conditions
- Colorectal Cancer Metastatic, Microsatellite Stable Colorectal Carcinoma, Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Jul 2024 (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.
Single-arm, open-label, multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR metastatic colorectal cancer.
Detailed description
Metastatic colorectal cancer (mCRC) remains an incurable disease characterized by a poor prognosis. Recently, in the global phase 3 SUNLIGHT (NCT04737187) study, adding Bevacizumab to Trifluridine/Tipiracil (FTD/TPI) in the treatment of refractory mCRC significantly improved overall survival. Therefore, this combination regimen is going to become the new standard of care for refractory mCRC. Immune checkpoint inhibitors (ICIs), including Pembrolizumab, have shown excellent results in MSI-H or dMMR mCRC, and recent trials evaluating both concomitant and sequential chemoimmunotherapy in MSS/pMMR mCRC (in particular ATEZOTRIBE and MAYA trials), have shown promising results. Since 2001, we have treated more than 80 advanced melanoma patients with a tumor lysate loaded autologous DC vaccine, observing a clinical benefit of 54.1% and, more importantly, an ORR of 63.6% to subsequent chemotherapy, suggesting that immunotherapy might improve the activity of sequential chemotherapy. Moreover, our team has recently concluded the first step of 2 ongoing clinical studies with DC vaccine administration, in radically resected mCRC and metastatic mesothelioma patients - showing that the vaccine was safe and promoted immunological responses that allowed it to continue with patients enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label, multicenter phase 2 clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sequential immunochemotherapy with Pembrolizumab plus DC Vaccine, followed by FTD/TPI + Bevacizumab | Experimental | Biological: Autologous Dendritic Cell (DC) VaccineInduction phase: In the immunological induction phase patients will be given DCs intradermally every week for up to 4 doses and then a further administration after 3 weeks and Pembrolizumab 200 mg IV q3w for up to 3 cycle. Maintenance phase: patients will receive FTD/TPI combined with Bevacizumab.Treatment with FTD/TPI and Bevacizumab will start regardless of the response obtained with the induction combo immunotherapy, and will continue until confirmed disease progression, unacceptable toxicity or withdrawal of the consent by the patient, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be willing and able to provide written informed consent.
- Histologically confirmed pMMR or MSS mCRC
- Male or female, aged ≥ 18 years
- Life expectancy greater than 12 weeks
- ECOG performance status <2
Key exclusion criteria (10 listed)
- Prior treatment with FTD/TPI for mCRC
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab, FTD/TPI, Bevacizumab or components of the DC vaccine.
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 Cell (DC) VaccineInduction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR metastatic colorectal cancer. | Biological | Sequential immunochemotherapy with Pembrolizumab plus DC Vaccine, followed by FTD/TPI + Bevacizumab |
Primary outcome
Overall Response Rate (ORR)
Time frame: 2 years
The primary endpoint is Overall Response Rate (ORR) of chemotherapy, defined as the percentage of patients experiencing partial response (PR) or complete response (CR), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, after starting the treatment with FTD/TPI plus Bevacizumab.
12 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Safety evaluation
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
In vivo immunomonitoring through DTH test:
Time frame: 2 years
Characterization of patient's HLA class I immune response
Time frame: 2 years
Characterization of patient's HLA class II immune response
Time frame: 2 years
Characterization of patient's HLA-restricted immune response
Time frame: 2 years
Definition of the prognostic and predictive role of peripheral immune cell subsets and soluble factors
Time frame: 2 years
In situ characterization of pMMR mCRC through Next Generation Sequencing analysis
Time frame: 2 years
In situ characterization of MSS mCRC through Next Generation Sequencing analysis
Time frame: 2 years
In situ protein validation at the single cell level
Time frame: 2 years
Identification of tumor infiltrating immune cell subsets
Time frame: 2 years
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 Jan 2025.
- Derived from this study: PubMed 41275134Passardi A, Sullo FG, Bittoni A, Matteucci L, De Rosa F, Bulgarelli J, Tazzari M, Petrini M, Scarpi E, Testoni S, Miserocchi A, Tartagni O, Zani C, Iaia ML, Toma I, Viola MG, Mita MT, Tamburini E, Ridolfi L. CombiCoR-Vax trial: study protocol for a phase II, single-arm, multicenter trial of sequential pembrolizumab plus dendritic cell vaccine followed by trifluridine/tipiracil and bevacizumab in refractory microsatellite-stable metastatic colorectal cancer. BMC Cancer. 2025 Nov 22;25(1):1921. doi: 10.1186/s12885-025-15371-7.
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CRC
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.
Alessandro Passardi principal investigator
IRCCS IRST
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 Cell (DC) Vaccine in people with Colorectal Cancer Metastatic and Microsatellite Stable Colorectal Carcinoma, 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 14 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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?
Contact Oriana Nanni (0543739266, oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 2 years). 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 NCT06522919, which also lists 1 linked publication.
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 Jan 2025.