MelanomaPhase 1NCT03092453
Dendritic Cell Vaccination in Patients With Advanced Melanoma
A Phase 1 study testing Mature dendritic cell (DC) vaccine, Cyclophosphamide 300mg/m^2 and Pembrolizumab in people with Melanoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Mature dendritic cell (DC) vaccine, Cyclophosphamide 300mg/m^2 and Pembrolizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 Mar 2023
- 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
- Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
- Male or female patients age greater than or equal to 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):
- WBC (white blood cells) >3,000/mm3
- Hg (hemoglobin) greater than or equal to 9.0 gm/dl
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- Platelets >75,000/mm3
- Serum Bilirubin < 2.0 mg/dl
- Serum Creatinine < 2.0 mg/dl
- 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 treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
- Active untreated CNS (central nervous system) metastasis
- Active infection
- Prior malignancy (except non-melanoma skin cancer) within 3 years
- Pregnant or nursing (lactating) women
- Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted
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- Known allergy to eggs
- Prior history of uveitis or autoimmune inflammatory eye disease
- Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Read the detailed description
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).
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 or by mouth 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 melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.
- Conditions
- Melanoma
- Being tested
- Mature dendritic cell (DC) vaccine, Cyclophosphamide 300mg/m^2, Pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mature dendritic cell (DC) vaccineBiological
Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m^2Drug
administered prior to subject's first DC dose
PembrolizumabDrug
administered 7-8 weeks after subject's last DC dose
| Study group | Role | What they receive |
|---|---|---|
| Mature dendritic cell (DC) vaccine | Experimental | Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy Receives: Biological: Mature dendritic cell (DC) vaccine; Drug: Cyclophosphamide 300mg/m^2; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.
Measured: Screening through week 21
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.
Measured: End of Study visit (10-28 days after last DC vaccine)
Secondary outcomes (3)
Clinical Response to the mDC3/8 Vaccine(s)
using RECIST 1.1
Measured: At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)
Time to Progression Post-mDC3/8 Vaccine Administration
based on RECIST 1.1 criteria, until occurrence of a censoring event
Measured: Up to 30 weeks after the first mDC3/8 Vaccine
Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide.
Assessed through collection of Adverse Events.
Measured: End of Study visit (10-28 days after last DC vaccine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 May 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 MelanomaStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald P Linette, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092453
- Sponsor's protocol ID
- UPCC 17616, 826433
- Other IDs
- 17616
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2017
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03092453
- Acronym / sponsor ID
- UPCC 17616, 826433
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Detailed description
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).
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 or by mouth 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 melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mature dendritic cell (DC) vaccine | Experimental | Biological: Mature dendritic cell (DC) vaccine, Drug: Cyclophosphamide 300mg/m^2, Drug: PembrolizumabMature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
- Male or female patients age greater than or equal to 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):
- 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.
Key exclusion criteria (9 listed)
- Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
- Active untreated CNS (central nervous system) metastasis
- Active infection
- Prior malignancy (except non-melanoma skin cancer) within 3 years
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| Mature dendritic cell (DC) vaccineMature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy. | Biological | Mature dendritic cell (DC) vaccine |
| Cyclophosphamide 300mg/m^2administered prior to subject's first DC dose | Drug | Mature dendritic cell (DC) vaccine |
| Pembrolizumabadministered 7-8 weeks after subject's last DC dose | Drug | Mature dendritic cell (DC) vaccine |
Primary outcome
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Time frame: Screening through week 21
Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Time frame: End of Study visit (10-28 days after last DC vaccine)
Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.
3 secondary outcomes
Clinical Response to the mDC3/8 Vaccine(s)
Time frame: At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)
Time to Progression Post-mDC3/8 Vaccine Administration
Time frame: Up to 30 weeks after the first mDC3/8 Vaccine
Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide.
Time frame: End of Study visit (10-28 days after last DC vaccine)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gerald P Linette, MD, PhD 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 Mature dendritic cell (DC) vaccine, Cyclophosphamide 300mg/m^2 and Pembrolizumab in people with Melanoma, 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 11 inclusion and 9 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 24 Dec 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 Dec 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?
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. (time frame: Screening through week 21). 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 24 Dec 2024.