Last updated: April 30, 2024
Sponsor: University of Louisville
Overall Status: Active - Recruiting
Phase
2
Condition
Melanoma
Skin Cancer
Treatment
Talimogene Laherparepvec
Pembrolizumab
Clinical Study ID
NCT03842943
181095
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 forintralesional 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 melanomaspecialist.
- Stage III disease can be at time of diagnosis of primary melanoma or a recurrenceafter initial treatment of stage I-II disease.
- BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
- Signed, written informed consent
Exclusion
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 othermalignancies (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, documenthistory of autoimmune disease or syndrome requiring systemic treatment in the past twoyears (i.e. use of disease modifying agents, steroids, or immunosuppressive agents)except vitiligo or resolved childhood asthma/atopy, or evidence of clinicallysignificant immunosuppression
- Must not have active herpetic skin lesions or prior complications of herpeticinfection and must not require intermittent or chronic treatment with an anti-herpeticdrug (e.g. acyclovir) other than intermittent topical use
Study Design
Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Talimogene Laherparepvec
Phase: 2
Study Start date:
July 03, 2019
Estimated Completion Date:
June 01, 2028
Study Description
Connect with a study center
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting

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