Neoadjuvant Combination Immunotherapy for Stage III Melanoma

NCT03842943 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 181095
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Melanoma

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection

  6 months

Secondary Outcomes (1)

• Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events

  Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years

Study Arms (1)

Combination T-VEC/Pembrolizumab

EXPERIMENTAL

Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors. Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.

Drug: Pembrolizumab; Drug: Talimogene Laherparepvec

Interventions

Pembrolizumab DRUG

Preoperative infusions

Also known as: Keytruda

Combination T-VEC/Pembrolizumab

Talimogene Laherparepvec DRUG

Preoperative intralesional injection

Also known as: T-VEC, Imlygic

Combination T-VEC/Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab; talimogene laherparepvec

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Egger, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Egger, MD

CONTACT

502-629-6950; michael.egger@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 15, 2019
• Study Start: July 3, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

US (1)