Actively Recruiting
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Led by University of Louisville · Updated on 2024-05-02
28
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, any race or sex, with confirmed cutaneous melanoma
- ECOG performance status of 0 or 1
- Adequate blood, liver, kidney, and coagulation function
- Measurable disease and injectable target lymph node for therapy
- Primary melanoma tumor surgically removed
- Pathologically confirmed resectable stage III disease with visible lymph node metastases
- Stage III disease may be present at initial diagnosis or as recurrence after stage I-II disease
- BRAF mutation status can be mutant or wild type
- Signed informed consent
You will not qualify if you...
- Presence of metastatic (AJCC M1) melanoma
- Primary mucosal or uveal melanoma
- Melanoma related to immunodeficiency or other cancers within past 3 years (except non-melanoma skin cancer)
- Prior treatment with T-VEC, other oncolytic viruses, pembrolizumab, or PD-1/PD-L1/PD-L2 inhibitors
- History or evidence of symptomatic autoimmune diseases requiring recent systemic treatment (except vitiligo or resolved childhood asthma/atopy)
- Clinically significant immunosuppression
- Active herpes skin lesions or history of herpes complications requiring ongoing anti-herpetic medication (other than intermittent topical use)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
M
Michael Egger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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