RECRUITING

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Quick Facts

Study Start:2019-07-03

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03842943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael Egger, MD

CONTACT

502-629-6950

michael.egger@louisville.edu

Principal Investigator

Michael Egger, MD

PRINCIPAL_INVESTIGATOR

University of Louisville

Study Locations (Sites)

University of Louisville

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: University of Louisville

Michael Egger, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-03

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2019-07-03

Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

Cutaneous Melanoma