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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03842943
Other study ID # 181095
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 3, 2019
Est. completion date June 1, 2028

Study information

Verified date April 2024
Source University of Louisville
Contact Michael Egger, MD
Phone 502-629-6950
Email michael.egger@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 1, 2028
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Pembrolizumab
Preoperative infusions
Talimogene Laherparepvec
Preoperative intralesional injection

Locations

Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic Complete Response Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection 6 months
Secondary Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events Adverse events and Serious Adverse Events will be collected Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
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