Melanoma
Conditions
Keywords
melanoma
Brief summary
This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.
Interventions
DRUGMORAb028
1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.
Sponsors
Morphotek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules) * Tumor accessible to intra-tumoral injections * Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3
Exclusion criteria
* Are candidates for curative surgical excision or lymphadenectomy * Prior non-surgical treatment within 4 weeks * Known central nervous system (CNS) tumor involvement or metastases * Hypersensitivity to MORAb-028
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of multiple intralesional administration of MORAb-028 | Day 33 | After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of intralesional administration of MORAb-028 | 22 months |
Countries
United States
Outcome results
None listed