Pre-operative immunotherapy for stage III melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial evaluates the safety and efficacy of a combination immunotherapy using Talimogene Laherparepvec (T-VEC) and Pembrolizumab administered for six months before complete lymph node dissection in patients with resectable stage III cutaneous melanoma. The study focuses on individuals with clinically apparent lymph node metastases and aims to determine how well this pre-operative treatment can improve outcomes. Participants will receive the immunotherapy to potentially shrink tumors before surgical intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Louisville
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Michael Egger, MD — University of Louisville
• Study coordinator: Michael Egger, MD
• Email: michael.egger@louisville.edu
• Phone: 502-629-6950

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.