Neoadjuvant Combination Immunotherapy for Stage III Melanoma

NCT ID: NCT03842943

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2028-06-01

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.

Detailed 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.

Conditions

Cutaneous Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Combination T-VEC/Pembrolizumab

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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Preoperative infusions

Talimogene Laherparepvec

Intervention Type: DRUG

Preoperative intralesional injection

Interventions

Pembrolizumab

Preoperative infusions

Intervention Type: DRUG

Talimogene Laherparepvec

Preoperative intralesional injection

Intervention Type: DRUG

Other Intervention Names

Keytruda; T-VEC; Imlygic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Michael Egger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Egger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Egger, MD

Role: CONTACT

michael.egger@louisville.edu

502-629-6950

Facility Contacts

Stacy Baum

Role: primary

mary.baum@louisville.edu

502-562-4370

Other Identifiers

181095

Identifier Type: -

Identifier Source: org_study_id