Melanoma
Conditions
Keywords
Biosy accessible melanoma
Brief summary
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
Detailed description
MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)
Interventions
DRUGMRX34
Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
DRUGDexamethasone
Premedication during the week of treatment
Sponsors
Mirna Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * Advanced or metastatic cutaneous, acral or mucosal melanoma * Tumor lesions accessible to serial biopsies * ECOG ≤ 1 * ANC ≥, Plts ≥100,000 /mm3
Exclusion criteria
* Serious active non-malignant disease * Central Nervous System metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events associated with MRX34 treatment | 6 months |
Other
| Measure | Time frame |
|---|---|
| Change in tumor measurements over time using RECIST criteria. | 6 months |
| RNA sequencing analysis of PBMCs to evaluate gene expression through TLR signaling, RIG-I Pathway and PD1/PD-L1 Blockade. | During 3 months of treatment |
| Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH. | During 3 months of treatment |
Outcome results
None listed