NANO-technology Study ID Study Title Phase Drug Study design Study arms Condition
Immunotherapy NCT02054520 Immunotherapy Study for Patients With Stage IV Melanoma IIB HyperAcute®-Melanoma (HAM) Immunotherapy Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Experimental: HyperAcute®-Melanoma (HAM) Immunotherapy + Ipilimumab Active Comparator: Ipilimumab Alone   Stage 4 melanoma
Polymeric Nanoparticles NCT02158520 Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery II paclitaxel albumin-stabilized nanoparticle formulation Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Experimental: Arm A (nab-paclitaxel and bevacizumab) Experimental: Arm B (ipilimumab)   • Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
Stage IV Melanoma
Polymeric
Nanoparticles
NCT00626405 Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery II Biological: bevacizumab
Drug: carboplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: temozolomide
Allocation: Randomized
Primary Purpose: Treatmen
Experimental: Arm I
Interventions: • Biological:bevacizumab
   Drug: temozolomide Experimental: Arm II
Interventions: • Biological: bevacizumab
• Drug: carboplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
MELANOMA
siRNA NCT00689065 A Phase I, Dose-Escalating Study of the Safety of Intravenous CALAA-01 in Adults With Solid Tumors Refractory to Standard-of-Care Therapies I CALAA-01: a small interfering RNA (siRNA). This siRNA inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation within a stabilized nanoparticle targeted to tumor cells. Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatmen
Experimental: CALAA-01
Intervention: Drug: CALAA-01
Solid Tumours
Polymeric Nanoparticles NCT00404235 Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery ii • Drug: carboplatin
• Drug: paclitaxel albumin-stabilized nanoparticle formulation
 
Masking: Open Label
Primary Purpose: Treatment
This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery. Melanoma
Quantum Dots NCT02106598 Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients 0 fluorescent cRGDY-PEG-Cy5.5-C dots Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Melanoma patients will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours the location of the later using a device to image the dye.  
ADC (antibody drug conjugates) NCT02129075 CDX-1401 and Poly-ICLC Vaccine Therapy With or Without CDX-301in Treating Patients With Stage IIB-IV Melanoma ii   Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
This randomized phase II trial studies how well DEC-205/NY-ESO-1 fusion protein CDX-1401 (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage IIB-IV melanoma  
Immunotherapy NCT01814046 Adoptive T Cell Therapy for Metastatic Ocular Melanoma II Drug: Aldesleukin Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Participants will receive an infusion of their collected white blood cells. They will also receive aldesleukin for up to 5 days to boost the immune system's response to the white blood cells. • Metastatic Ocular Melanoma
Metastatic Uveal Melanoma
Immunotherapy NCT01863108 Safety Study of a Dendritic Cell-based Cancer Vaccine in Melanoma i GeniusVac-Mel4:a drug product composed of an irradiated allogeneic plasmacytoid dendritic cell (PDC) line loaded with 4 melanoma peptides derived from Melan-A, gp100, Tyrosinase or Mage-A3 Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Experimental: GeniusVac-Mel4
Sub-cutaneous injections of GeniusVac-Mel4 in patients with melanoma.
Intervention: Biological: GeniusVac-Mel4
melanoma
Quantum Dots NCT01266096 PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study   PET scan with 124I-cRGDY-PEG-dots Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Newly Diagnosed or Recurrent Metastatic Melanoma Patients
Malignant Brain Tumors
siRNA NCT01941927 Trametinib With GSK2141795 in BRAF Wild-type Melanoma Ii • Drug: Trametinib (GSK1120212)
Drug: GSK2141795
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
   
Tumour targetting NCT02236546 FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma   18F]fluorodeoxyglucose
(FDG)
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). • Recurrent Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
Stage IV Melanoma
Imaging NCT02106598 Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients 0 fluorescent cRGDY-PEG-Cy5.5-C dots Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Melanoma patients will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours the location of the later using a device to image the dye. • Head and Neck Cancer
• Melanoma
• Prostate Cancer
• Cervical Cancer
Uterine Cancer
Imaging   Sentinel Node Biopsy using Magnetic Nanoparticles for melanoma   Sienna+ Detection rate with either the standard (blue dye and isotope) or the new technique (magnetic)
Timepoint(s): The proportion of sentinel nodes detected (detection rate) with either the standard or the new magnetic technique
Non-randomised; Interventional; Design type: Diagnosis melanoma
siRNA NCT00672542 Immunotherapy of
Melanoma With Tumor
Antigen RNA and
Small Inhibitory RNA
Transfected Autologous
Dendritic Cells
I Proteasome siRNA
and tumor antigen
RNA-transfected
dendritic cells
Allocation: Non-
Randomized
Endpoint Classification:
Safety Study
Intervention Model: Single
Group Assignment
Masking: Open Label
Primary Purpose:
Treatment
• Experimental: A
siRNA loaded
dendritic cells derived
from untreated
monocytes Intervention:
Biological: Proteasome
siRNA and tumor
antigen RNAtransfected
dendritic
cells
• Experimental: B
Vaccination with
melanoma tumor
associated antigen
RNA loaded dendritic
cells derived from
monocytes transfected
with control siRNA
Intervention: Biological:
Proteasome siRNA and
tumor antigen RNAtransfected
dendritic
cells
Experimental: C
Vaccination with
melanoma tumor
associated antigen
RNA loaded dendritic
cells derived from
monocytes transfected
with siRNA targeting
the three inducible
immunoproteasome
subunits Intervention:
Biological: Proteasome
siRNA and tumor
antigen RNAtransfected
dendritic
cells
Metastatic
Melanoma with
Absence of CNS
Metastases
siRNA NCT02166255 APN401 in Treating
Patients With Melanoma,
Kidney Cancer,
Pancreatic Cancer, or
Other Solid Tumors That
Are Metastatic or Cannot
Be Removed By Surgery
I siRNA-transfected
peripheral blood
mononuclear cells
APN401
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Single
Group Assignment
Masking: Open Label
Primary Purpose:
Treatment
Experimental:
Treatment (APN401)
• Recurrent
Melanoma
• Recurrent
Pancreatic Cancer
• Recurrent
Renal Cell Cancer
• Stage III
Pancreatic Cancer
• Stage III Renal
Cell Cancer
• Stage IIIA
Melanoma
• Stage IIIB
Melanoma
• Stage IIIC
Melanoma
• Stage IV
Melanoma
• Stage IV
Pancreatic Cancer
• Stage IV Renal
Cell Cancer
Unspecified Adult
Solid Tumor,
Protocol Specific
Table 1: Current clinical trials making use of nano-technology in melanoma (as per www.clinicaltrials.gov) (101).