Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Cutaneous Melanoma Clinical Trial

Official title:

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842943
• Other study ID #: 181095
• Status: Recruiting
• Phase: Phase 2
• Start date: July 3, 2019
• Est. completion date: June 1, 2027

Study information

• Verified date: July 2022
• Source: University of Louisville
• Contact: Michael Egger, MD
• Phone: 502-629-6950
• Email: michael.egger[@]louisville.edu
• Is FDA regulated: No
• 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, 2027
• Est. primary completion date: June 1, 2024
• 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

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

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