RecruitingPhase 2NCT03842943

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Sponsor

University of Louisville

Enrollment

28 participants

Start Date

Jul 3, 2019

Study Type

INTERVENTIONAL

Conditions

Cutaneous Melanoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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