Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Purpose

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.

Condition

  • Cutaneous Melanoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Combination T-VEC/Pembrolizumab 		Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors. Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
  • Drug: Pembrolizumab
    Preoperative infusions
    Other names:
    • Keytruda
  • Drug: Talimogene Laherparepvec
    Preoperative intralesional injection
    Other names:
    • T-VEC
    • Imlygic

Recruiting Locations

University of Louisville
Louisville, Kentucky 40202
Contact:
Stacy Baum
502-562-4370
mary.baum@louisville.edu

More Details

Status
Recruiting
Sponsor
University of Louisville

Study Contact

Michael Egger, MD
502-629-6950
michael.egger@louisville.edu

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.