Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Last updated: April 30, 2024
Sponsor: University of Louisville
Overall Status: Active - Recruiting

Phase

2

Condition

Melanoma

Skin Cancer

Treatment

Talimogene Laherparepvec

Pembrolizumab

Clinical Study ID

NCT03842943
181095
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forintralesional 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 melanomaspecialist.
  • Stage III disease can be at time of diagnosis of primary melanoma or a recurrenceafter initial treatment of stage I-II disease.
  • BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
  • Signed, written informed consent

Exclusion

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 othermalignancies (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, documenthistory of autoimmune disease or syndrome requiring systemic treatment in the past twoyears (i.e. use of disease modifying agents, steroids, or immunosuppressive agents)except vitiligo or resolved childhood asthma/atopy, or evidence of clinicallysignificant immunosuppression
  • Must not have active herpetic skin lesions or prior complications of herpeticinfection and must not require intermittent or chronic treatment with an anti-herpeticdrug (e.g. acyclovir) other than intermittent topical use

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Talimogene Laherparepvec
Phase: 2
Study Start date:
July 03, 2019
Estimated Completion Date:
June 01, 2028

Study 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.

Connect with a study center

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

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