A Phase 1 interventional study of Mature dendritic cell (DC) vaccine and Cyclophosphamide 300mg/m^2 in Melanoma, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by University of Pennsylvania · Phase 1, Interventional, and Treatment
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.
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 5 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):
Exclusion Criteria:
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
Biological: Mature dendritic cell (DC) vaccine · Drug: Cyclophosphamide 300mg/m^2 · Drug: Pembrolizumab
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.
Drug page: Cyclophosphamide
administered prior to subject's first DC dose
administered 7-8 weeks after subject's last DC dose
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.
Time frame: 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.
Time frame: End of Study visit (10-28 days after last DC vaccine)
Clinical Response to the mDC3/8 Vaccine(s)
using RECIST 1.1
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
based on RECIST 1.1 criteria, until occurrence of a censoring event
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.
Assessed through collection of Adverse Events.
Time frame: End of Study visit (10-28 days after last DC vaccine)
| Milestone | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Started | 5 |
| Completed | 3 |
| Not completed | 2 |
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.
| percent of CD8+ T cells | Subject 1 | Subject 2 | Subject 3 | Subject 4 |
|---|---|---|---|---|
| Antigen A3-1, screening | 0 | — | 0 | 0 |
| Antigen A3-2, screening | 0 | — | 0 | 0 |
| Antigen A3-3, screening | 0 | — | 0 | 0 |
| Antigen A3-4, screening | 0 | — | 0 | 0 |
| Antigen A3-5, screening | 0 | — | 0 | 0 |
| Antigen A3-6, screening | 0 | — | 0 | 0 |
| Antigen A3-7, screening | 0 | — | 0 | — |
| Antigen B8-1, screening | 0 | — | — | — |
| Antigen B8-3, screening | 0.26 | — | — | — |
| Antigen B8-4, screening | 0 | — | — | — |
| Antigen B8-5, screening | 0 | — | — | — |
| Antigen A3-1, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-2, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-3, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-4, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-5, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-6, Day 1 | 0 | — | 0 | 0 |
| Antigen A3-7, Day 1 | 0 | — | — | — |
| Antigen B8-1, Day 1 | 0.4 | — | — | — |
| Antigen B8-3, Day 1 | 0.48 | — | — | — |
| Antigen B8-4, Day 1 | 0 | — | — | — |
| Antigen B8-5, Day 1 | 0 | — | — | — |
| Antigen A3-1, wk 14-15 | 0 | — | 0 | 0.86 |
| Antigen A3-2, wk 14-15 | 0 | — | 0 | 2.66 |
| Antigen A3-3, wk 14-15 | 0 | — | 0 | 0 |
| Antigen A3-4, wk 14-15 | 0 | — | 0 | 4.01 |
| Antigen A3-5, wk 14-15 | 0 | — | 0 | 0 |
| Antigen A3-6, wk 14-15 | 0 | — | 2.4 | 0 |
| Antigen A3-7, wk 14-15 | 0 | — | — | — |
| Antigen B8-1, wk 14-15 | 0.32 | — | — | — |
| Antigen B8-3, wk 14-15 | 5.68 | — | — | — |
| Antigen B8-4, wk 14-15 | 0 | — | — | — |
| Antigen B8-5, wk 14-15 | 0 | — | — | — |
| Antigen A3-1, wk 17 | 0 | — | 0 | — |
| Antigen A3-2, wk 17 | 0 | — | 0 | — |
| Antigen A3-3, wk 17 | 0 | — | 0 | — |
| Antigen A3-4, wk 17 | 0 | — | 0 | — |
| Antigen A3-5, wk 17 | 0 | — | 0 | — |
| Antigen A3-6, wk 17 | 0 | — | 0 | — |
| Antigen A3-7, wk 17 | 0 | — | — | — |
| Antigen B8-1, wk 17 | 0.5 | — | — | — |
| Antigen B8-3, wk 17 | 1.81 | — | — | — |
| Antigen B8-4, wk 17 | 0 | — | — | — |
| Antigen B8-5, wk 17 | 0 | — | — | — |
| Antigen A3-1, wk 19 | 0 | — | 0 | — |
| Antigen A3-2, wk 19 | 0 | — | 0 | — |
| Antigen A3-3, wk 19 | 0 | — | 0 | — |
| Antigen A3-4, wk 19 | 0 | — | 0 | — |
| Antigen A3-5, wk 19 | 0 | — | 0 | — |
| Antigen A3-6, wk 19 | 0 | — | 0 | — |
| Antigen A3-7, wk 19 | 0 | — | — | — |
| Antigen B8-1, wk 19 | 0.32 | — | — | — |
| Antigen B8-3, wk 19 | 0.99 | — | — | — |
| Antigen B8-4, wk 19 | 0 | — | — | — |
| Antigen B8-5, wk 19 | 0 | — | — | — |
| Antigen A3-1, wk 21 | 0 | — | 0 | — |
| Antigen A3-2, wk 21 | 0 | — | 0 | — |
| Antigen A3-3, wk 21 | 0 | — | 0 | — |
| Antigen A3-4, wk 21 | 0 | — | 0 | — |
| Antigen A3-5, wk 21 | 0 | — | 0 | — |
| Antigen A3-6, wk 21 | 0 | — | 0 | — |
| Antigen A3-7, wk 21 | 0 | — | — | — |
| Antigen B8-1, wk 21 | 1.4 | — | — | — |
| Antigen B8-3, wk 21 | 0.16 | — | — | — |
| Antigen B8-4, wk 21 | 0 | — | — | — |
| Antigen B8-5, wk 21 | 0 | — | — | — |
| Antigen B15-1, screening | — | 0 | — | — |
| Antigen B15-2, screening | — | 0 | — | — |
| Antigen B15-3, screening | — | 0 | — | — |
| Antigen B15-4, screening | — | 0 | — | — |
| Antigen B15-5, screening | — | 0 | — | — |
| Antigen B44-1, screening | — | 0 | — | — |
| Antigen A31-1, screening | — | 0 | — | — |
| Antigen A31-2, screening | — | 0 | — | — |
| Antigen B15-1, day 1 | — | 0 | — | — |
| Antigen B15-2, day 1 | — | 0 | — | — |
| Antigen B15-3, day 1 | — | 0 | — | — |
| Antigen B15-4, day 1 | — | 0 | — | — |
| Antigen B15-5, day 1 | — | 0 | — | — |
| Antigen B44-1, day 1 | — | 0 | — | — |
| Antigen A31-1, day 1 | — | 0 | — | — |
| Antigen A31-2, day 1 | — | 0 | — | — |
| Antigen B15-1, wk 14 | — | 0 | — | — |
| Antigen B15-2, wk 14 | — | 35 | — | — |
| Antigen B15-3, wk 14 | — | 27.2 | — | — |
| Antigen B15-4, wk 14 | — | 0 | — | — |
| Antigen B15-5, wk 14 | — | 36.5 | — | — |
| Antigen B44-1, wk 14 | — | 22.7 | — | — |
| Antigen A31-1, wk 14 | — | 0 | — | — |
| Antigen A31-2, wk 14 | — | 0 | — | — |
| Antigen B15-1, wk 17 | — | 0 | — | — |
| Antigen A31-1, wk 17 | — | 0 | — | — |
| Antigen A31-2, wk 17 | — | 0 | — | — |
| Antigen B15-1, wk 19 | — | 0 | — | — |
| Antigen A31-1, wk 19 | — | 0 | — | — |
| Antigen A31-2, wk 19 | — | 0 | — | — |
| Antigen B15-1, wk 21 | — | 0 | — | — |
| Antigen B15-2, wk 21 | — | 34.7 | — | — |
| Antigen B15-3, wk 21 | — | 27.7 | — | — |
| Antigen B15-4, wk 21 | — | 0 | — | — |
| Antigen B15-5, wk 21 | — | 33.9 | — | — |
| Antigen B44-1, wk 21 | — | 17.4 | — | — |
| Antigen A31-1, wk 21 | — | 0 | — | — |
| Antigen A31-2, wk 21 | — | 0 | — | — |
| Antigen A3-8, screening | — | — | 0 | 0 |
| Antigen A3-9, screening | — | — | 0 | 0 |
| Antigen A3-10, screening | — | — | 0 | 0 |
| Antigen A3-11, screening | — | — | 0 | 0 |
| Antigen A3-8, day 1 | — | — | 0 | 0 |
| Antigen A3-9, day 1 | — | — | 0 | 0 |
| Antigen A3-10, day 1 | — | — | 0 | 0 |
| Antigen A3-11, day 1 | — | — | 0 | 0 |
| Antigen A3-8, wk 14 | — | — | 0 | 1.15 |
| Antigen A3-9, wk 14 | — | — | 0 | 1.08 |
| Antigen A3-10, wk 14 | — | — | 0 | 0.9 |
| Antigen A3-11, wk 14 | — | — | 10.8 | 0.14 |
| Antigen A3-8, wk 17 | — | — | 0 | — |
| 0Antigen A3-9, wk 17 | — | — | 0 | — |
| Antigen A3-10, wk 17 | — | — | 0 | — |
| Antigen A3-11, wk 17 | — | — | 0 | — |
| Antigen A3-8, wk 19 | — | — | 0 | — |
| Antigen A3-9, wk 19 | — | — | 0 | — |
| Antigen A3-10, wk 19 | — | — | 0 | — |
| Antigen A3-11, wk 19 | — | — | 0 | — |
| Antigen A3-8, wk 21 | — | — | 0 | — |
| Antigen A3-9, wk 21 | — | — | 0 | — |
| Antigen A3-10, wk 21 | — | — | 0 | — |
| Antigen A3-11, wk 21 | — | — | 0 | — |
| Antigen A3-12, screening | — | — | — | 0 |
| Antigen A3-13, screening | — | — | — | 0 |
| Antigen A3-12, day 1 | — | — | — | 0 |
| Antigen A3-13, day 1 | — | — | — | 0 |
| Antigen A3-12, wk 14 | — | — | — | 0 |
| Antigen A3-13, wk 14 | — | — | — | 1.48 |
Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.
| Participants | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Completed primary follow-up | 3 |
| Did not complete primary follow-up | 2 |
using RECIST 1.1
| Participants | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Progressive disease | 2 |
| Not evaluable | 3 |
based on RECIST 1.1 criteria, until occurrence of a censoring event
| days | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Subject 1 | 113 |
| Subject 2 | NA |
| Subject 3 | NA |
| Subject 4 | NA |
| Subject 5 | 80 |
Assessed through collection of Adverse Events.
| Participants | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide. | 5 |
Collected over Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mature Dendritic Cell (DC) Vaccine | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/5 |
| Surgical and medical procedures - Other (Palliative mass resection)Surgical and medical procedures | 1/5 |
| Event | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| NauseaGastrointestinal disorders | 3/5 |
| ChillsGeneral disorders | 2/5 |
| FatigueGeneral disorders | 2/5 |
| HeadacheNervous system disorders | 2/5 |
| Cardiac disorders - other )tachycardia)Cardiac disorders | 1/5 |
| Abdominal PainGastrointestinal disorders | 1/5 |
| ConstipationGastrointestinal disorders | 1/5 |
| Dental CariesGastrointestinal disorders | 1/5 |
| ToothacheGastrointestinal disorders | 1/5 |
| Flu like symptomsGeneral disorders | 1/5 |
| Age, Categorical(Participants) | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| Female | 2 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Mature Dendritic Cell (DC) Vaccine |
|---|---|
| United States | 5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from May 2017 to primary completion in Mar 2023, 70 months.
Results were first posted in Dec 2024, 1 year 8 months after primary completion.
Of 171 non-industry phase 1 interventional studies under Melanoma, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's 70 months is above that.
Counting every sponsor, half of 346 studies reached it within 49 months; a quarter within 32 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Pembrolizumab