Malignant MelanomaPhase 2ACDCNCT02718391
Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients.
A Phase 2 study testing Autologous Dendritic Cell vaccine in people with Malignant Melanoma and Adjuvant Drug Therapy, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
Trial summary
This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Adjuvant Drug Therapy, Vaccin Therapy
- What is being tested?
- Autologous Dendritic Cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2015to Nov 2019
- Phase
- Phase 2
- 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
- Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure.
- Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the "Product Specification File".
- Patients must have histologically or cytologically confirmed melanoma (all type of melanomas);
- Patients must be disease free after surgical removal of a metastatic lesions (stage IV or metachronous stage III)
- Eastern Cooperative Oncology Group performance status 0-1
- Negative screening tests for HIV, Hepatitis B virus, Hepatitis C virus and syphilis not older than 30 days before performing any of the Good Manufacturing Practice-regulated activities required (leukapheresis, collection of tumor biopsies to be used for tumor lysate/homogenate preparation);
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- Men and women aged ≥ 18 years.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up 8 weeks after the study, in order to minimize the risk of pregnancy;
- Patients must have normal organ and marrow function according to clinical practice.
Who cannot join
- Patients who have positive tests to Hepatitis B virus, Hepatitis C virus HIV, or syphilis (specific blood testing must be performed within 30 days before any Good Manufacturing Practice-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor lysate preparation).
- Patients who have had prior lines of systemic chemotherapy, immunotherapy or biological therapy for metastatic melanoma.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Uncontrolled 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 that would limit compliance with study requirements (on physician's judgment).
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
- Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, thrombocytopenia, oral anticoagulant therapy) or to undergo surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
UO Immunoterapia e laboratorio TCS, IRST IRCCS
Meldola, FC, 47014
UO Oncologia Medica, IRCCS IRST
Meldola (FC), FC, 47014
About this study
Official title: Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients: a Phase II Randomized Trial (ACDC Adjuvant Trial)
This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.
Read the detailed description
This study will be a randomized phase II trial (1:1 allocation ratio) in resected stage III/IV melanoma patients. The randomization list will be stratified by stage (III and IV M1a-b and IVM1c), and time from primitive tumor to first metastasis (≤ 2 years versus > 2 years). Five randomization lists will be defined, one for each stratum.
On the basis of literature, the investigators assume a median relapse-free survival of 7.0 months for the standard group. With a two-sided tailed alpha of 0.10 and power of 80%, assuming a median relapse-free survival of 11.7 months in the experimental arm (hazard ratio 0.60), it will be necessary to recruit 60 patients per arm over a period of 24 months and to have a subsequent 12 months of follow-up. In the context of data monitoring board activities, an interim analysis for futility, according to the Bayesian approach, will be performed at 18 months in order to control the safety.
Primary endpoints will be relapse free survival. Secondary end points will be OS, In vivo and in vitro immunomonitoring. Immunologic efficacy will be measured by best Delayed Type Hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses, alone or combined with Interferon-g ELISPOT analysis of tumor antigen-specific circulating effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples. In vivo monitoring will focus on functional phenotyping of circulating immune effectors/regulators, functional characterization of circulating tumor antigen-specific immune effectors and regulators, and identification of serum markers that are predictive of response.
- Conditions
- Malignant Melanoma, Adjuvant Drug Therapy, Vaccin Therapy
- Being tested
- Autologous Dendritic Cell vaccine
- Keywords
- Intradermal Autologous Dendritic Cell Vaccine, Malignant Melanoma, Adjuvant, vaccin, therapy, randomized trial, observation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Dendritic Cell vaccineBiological
The Dendritic Cells vaccine is given intradermally with 5 injections in sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis; as a rule, vaccine administrations should be performed by alternating injections sites. Two days after each vaccine administration, daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Autologous Dendritic Cell vaccine | Experimental | Daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days starting from the second day after each vaccine dose. Vaccine doses will be given intradermally in two sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis.The first dose (WK1) will consist of freshly prepared vaccine, whereas for all the further doses cryopreserved aliquots will be utilized. The remaining 5 doses will be administered every 4 weeks to complete six months of therapy (six vaccines). Receives: Biological: Autologous Dendritic Cell vaccine |
| Arm B: follow up | No intervention | Arm B: Patients will undergo laboratory and clinical assessment, tumor re-staging, blood collection for immunological biomarkers every 12 weeks until relapse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
Measured: The time from the date of randomization to the date of the first relapse or the date of death from any cause or the date of the last restaging in non relapsed patients, assessed up to 36 months
Secondary outcomes (2)
Overall survival (OS)
Measured: From the date of randomization until the date of death from any cause or the last date the patient was known to be alive, assessed up to 36 months
Immunologic efficacy will be measured by best delayed-type hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2019
- Study completionNov 2019
Why it stopped: The randomization to the observational arm of the trial was no longer ethical
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 Malignant MelanomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- Laura Ridolfi, MD, Principal investigator, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718391
- Sponsor's protocol ID
- IRST172.04
- Other IDs
- 2014-005123-27, 2014
- Acronym
- ACDC
- Status last verified
- Apr 2019
- First submitted
- 21 Jan 2016
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bulgarelli J, Piccinini C, Scarpi E, Gentili G, Renzi L, Carloni S, Limarzi F, Pancisi E, Granato AM, Petrini M, De Rosa F, Guidoboni M, Fanelli D, Tumedei MM, Tazzari M, Baravelli S, Bronico I, Cortesi P, Pignatta S, Capelli L, Ancarani V, Foschi G, Turci L, Tauceri F, Framarini M, Ridolfi L. Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial. J Transl Med. 2025 Apr 18;23(1):455. doi: 10.1186/s12967-025-06403-8.
PubMed 40251644
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients: a Phase II Randomized Trial (ACDC Adjuvant Trial)
- ClinicalTrials.gov ID
- NCT02718391
- Acronym / sponsor ID
- ACDC / IRST172.04
- Conditions
- Malignant Melanoma, Adjuvant Drug Therapy, Vaccin Therapy
- Keywords
- Intradermal Autologous Dendritic Cell Vaccine, Malignant Melanoma, Adjuvant, vaccin, therapy, randomized trial, observation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The randomization to the observational arm of the trial was no longer ethical
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 24 Mar 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.
This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.
Detailed description
This study will be a randomized phase II trial (1:1 allocation ratio) in resected stage III/IV melanoma patients. The randomization list will be stratified by stage (III and IV M1a-b and IVM1c), and time from primitive tumor to first metastasis (≤ 2 years versus > 2 years). Five randomization lists will be defined, one for each stratum.
On the basis of literature, the investigators assume a median relapse-free survival of 7.0 months for the standard group. With a two-sided tailed alpha of 0.10 and power of 80%, assuming a median relapse-free survival of 11.7 months in the experimental arm (hazard ratio 0.60), it will be necessary to recruit 60 patients per arm over a period of 24 months and to have a subsequent 12 months of follow-up. In the context of data monitoring board activities, an interim analysis for futility, according to the Bayesian approach, will be performed at 18 months in order to control the safety.
Primary endpoints will be relapse free survival. Secondary end points will be OS, In vivo and in vitro immunomonitoring. Immunologic efficacy will be measured by best Delayed Type Hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses, alone or combined with Interferon-g ELISPOT analysis of tumor antigen-specific circulating effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples. In vivo monitoring will focus on functional phenotyping of circulating immune effectors/regulators, functional characterization of circulating tumor antigen-specific immune effectors and regulators, and identification of serum markers that are predictive of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Autologous Dendritic Cell vaccine | Experimental | Biological: Autologous Dendritic Cell vaccineDaily 3 MU Interleukin 2 will be administered subcutaneously for 5 days starting from the second day after each vaccine dose. Vaccine doses will be given intradermally in two sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis.The first dose (WK1) will consist of freshly prepared vaccine, whereas for all the further doses cryopreserved aliquots will be utilized. The remaining 5 doses will be administered every 4 weeks to complete six months of therapy (six vaccines). |
| Arm B: follow up | No intervention | –Arm B: Patients will undergo laboratory and clinical assessment, tumor re-staging, blood collection for immunological biomarkers every 12 weeks until relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure.
- Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the "Product Specification File".
- Patients must have histologically or cytologically confirmed melanoma (all type of melanomas);
- Patients must be disease free after surgical removal of a metastatic lesions (stage IV or metachronous stage III)
- Eastern Cooperative Oncology Group performance status 0-1
Key exclusion criteria (6 listed)
- Patients who have positive tests to Hepatitis B virus, Hepatitis C virus HIV, or syphilis (specific blood testing must be performed within 30 days before any Good Manufacturing Practice-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor lysate preparation).
- Patients who have had prior lines of systemic chemotherapy, immunotherapy or biological therapy for metastatic melanoma.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Uncontrolled 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 that would limit compliance with study requirements (on physician's judgment).
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
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 vaccineThe Dendritic Cells vaccine is given intradermally with 5 injections in sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis; as a rule, vaccine administrations should be performed by alternating injections sites. Two days after each vaccine administration, daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days. | Biological | Arm A: Autologous Dendritic Cell vaccine |
Primary outcome
Relapse-free survival (RFS)
Time frame: The time from the date of randomization to the date of the first relapse or the date of death from any cause or the date of the last restaging in non relapsed patients, assessed up to 36 months
2 secondary outcomes
Overall survival (OS)
Time frame: From the date of randomization until the date of death from any cause or the last date the patient was known to be alive, assessed up to 36 months
Immunologic efficacy will be measured by best delayed-type hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses
Time frame: up to 36 months
Results and safety
The study was stopped early (reason given: The randomization to the observational arm of the trial was no longer ethical). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 40251644Bulgarelli J, Piccinini C, Scarpi E, Gentili G, Renzi L, Carloni S, Limarzi F, Pancisi E, Granato AM, Petrini M, De Rosa F, Guidoboni M, Fanelli D, Tumedei MM, Tazzari M, Baravelli S, Bronico I, Cortesi P, Pignatta S, Capelli L, Ancarani V, Foschi G, Turci L, Tauceri F, Framarini M, Ridolfi L. Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial. J Transl Med. 2025 Apr 18;23(1):455. doi: 10.1186/s12967-025-06403-8.
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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.
Laura Ridolfi, MD principal investigator
IRST 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 Cell vaccine in people with Malignant Melanoma and Adjuvant Drug Therapy, 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 9 inclusion and 6 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 22 Apr 2020. 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?
The study was stopped early (reason given: The randomization to the observational arm of the trial was no longer ethical). Results are not available in the source record.
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?
Relapse-free survival (RFS) (time frame: The time from the date of randomization to the date of the first relapse or the date of death from any cause or the date of the last restaging in non relapsed patients, assessed up to 36 months). 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 NCT02718391, 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 22 Apr 2020.