Cutaneous Melanoma
Conditions
Brief summary
Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.
Detailed description
This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.
Interventions
DRUGPembrolizumab
Preoperative infusions
DRUGTalimogene Laherparepvec
Preoperative intralesional injection
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma * ECOG performance status of 0 or 1 * Adequate hematologic, hepatic, renal and coagulation function * Must have measurable disease and have an injectable target lymph node for intralesional therapy administration * Primary melanoma has been resected * Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist. * Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease. * BRAF mutant or wild type allowed (mutations status not necessary for enrollment) * Signed, written informed consent
Exclusion criteria
* Cannot have metastatic (AJCC M1) disease * No primary mucosal or uveal melanoma * No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years * May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor * Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression * Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response | 6 months | Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events | Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years | Adverse events and Serious Adverse Events will be collected |
Countries
United States
Contacts
Primary ContactMichael Egger, MD
Outcome results
None listed