Dendritic Cell Vaccination in Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT03092453|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : October 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Mature dendritic cell (DC) vaccine Drug: Cyclophosphamide 300mg/m^2 Drug: Pembrolizumab||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Mature dendritic cell (DC) vaccine
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
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: Cyclophosphamide 300mg/m^2
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. [ Time Frame: day 1 through week 18. After week 18 every third week for 12 weeks. ]Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay.
- Clinical response [ Time Frame: every three weeks for 18 weeks beginning after the subjects last DC vaccine ]using RECIST 1.1
- Time to progression [ Time Frame: 10-28 days after the third vaccine through study completion approximately 30 weeks after the first DC vaccine ]using RECIST 1.1
- Safety and side effects of vaccine per CTCAE 4.0 [ Time Frame: at time of consent through 30 days after the subjects last DC vaccine ]per CTCAE 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092453
|Contact: Gerald P Linette, MD, PhDfirstname.lastname@example.org|
|Contact: Emerging Medicine||855-216-0098||PennCancerTrials@emergingmed.com|
|Principal Investigator:||Gerald P Linette, MD, PhD||University of Pennsylvania|