MelanomaPhase 1/2NCT02574377
myDC/pDC in Stage III Melanoma Patients
A Phase 1/2 study testing A: myDC vaccination, B: pDC vaccination and C: combined myDC/pDC vaccination in people with Melanoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- A: myDC vaccination, B: pDC vaccination and C: combined myDC/pDC vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Sep 2021
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage III melanoma
- WHO performance status 0-1
- radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment
Who cannot join
- irresectable disease
- any concurrent adjuvant therapy
- concomitant use of oral immunosuppressive drugs
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients
This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.
Read the detailed description
Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.
- Conditions
- Melanoma
- Being tested
- A: myDC vaccination, B: pDC vaccination, C: combined myDC/pDC vaccination
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: myDC vaccinationDrug
B: pDC vaccinationDrug
C: combined myDC/pDC vaccinationDrug
| Study group | Role | What they receive |
|---|---|---|
| A: myDC vaccination | Experimental | intranodal injection with tumor peptide-loaded myeloid dendritic cells Receives: Drug: A: myDC vaccination |
| B: pDC vaccination | Experimental | intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells Receives: Drug: B: pDC vaccination |
| C: combined myDC/pDC vaccination | Experimental | intranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells Receives: Drug: C: combined myDC/pDC vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity - type I IFN
Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms.
Measured: up to 1.5 years
immunogenicity - response to KLH
Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.
Measured: up to 1.5 years
immunogenicity - T cells in DTH
Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.
Measured: up to 1.5 years
Secondary outcomes (5)
biodistribution/localization of pDC and myDC in the lymph node
biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques
Measured: within 1 week after vaccination 1
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Measured: up to 1.5 years
quality of life
To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.
Measured: 5 years
progression-free survival
time from radical lymph node dissection to recurrence of (distant) disease
Measured: 5 years
overall survival
time from radical lymph node dissection to death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winald Gerritsen, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574377
- Sponsor's protocol ID
- NL49528.000.14
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2015
- Last updated
- 20 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients
- ClinicalTrials.gov ID
- NCT02574377
- Acronym / sponsor ID
- NL49528.000.14
- Conditions
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 12 Oct 2015 (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 is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.
Detailed description
Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: myDC vaccination | Experimental | Drug: A: myDC vaccinationintranodal injection with tumor peptide-loaded myeloid dendritic cells |
| B: pDC vaccination | Experimental | Drug: B: pDC vaccinationintranodal injection with tumor peptide-loaded plasmacytoid dendritic cells |
| C: combined myDC/pDC vaccination | Experimental | Drug: C: combined myDC/pDC vaccinationintranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage III melanoma
- WHO performance status 0-1
- radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment
Key exclusion criteria (4 listed)
- irresectable disease
- any concurrent adjuvant therapy
- concomitant use of oral immunosuppressive drugs
- autoimmune diseases
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 |
|---|---|---|
| A: myDC vaccination | Drug | A: myDC vaccination |
| B: pDC vaccination | Drug | B: pDC vaccination |
| C: combined myDC/pDC vaccination | Drug | C: combined myDC/pDC vaccination |
Primary outcome
immunogenicity - type I IFN
Time frame: up to 1.5 years
Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms.
immunogenicity - response to KLH
Time frame: up to 1.5 years
Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.
immunogenicity - T cells in DTH
Time frame: up to 1.5 years
Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.
5 secondary outcomes
biodistribution/localization of pDC and myDC in the lymph node
Time frame: within 1 week after vaccination 1
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Time frame: up to 1.5 years
quality of life
Time frame: 5 years
progression-free survival
Time frame: 5 years
overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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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.
Winald Gerritsen principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A: myDC vaccination, B: pDC vaccination and C: combined myDC/pDC vaccination in people with Melanoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. 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 Netherlands. 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 combined 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunogenicity - type I IFN (time frame: up to 1.5 years). The study lists 3 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 20 Sep 2021.