Clinical trial · Interventional
Dendritic Cell Vaccination in Patients With Advanced Melanoma
Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma
NCT03092453CI-TRIAL-00084043completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 300mg/m^2 | Drug | — | UNRESOLVED |
| Mature dendritic cell (DC) vaccine | Biological | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mature dendritic cell (DC) vaccine
- description
- 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
- interventionNames
- Biological: Mature dendritic cell (DC) vaccine
- Drug: Cyclophosphamide 300mg/m^2
- Drug: Pembrolizumab
Primary outcomes (2)
- measure
- Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
- timeFrame
- Screening through week 21
- description
- 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.
- measure
- Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.