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Recruiting NCT03842943

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Phase II Interventional Cutaneous Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pembrolizumab, Talimogene Laherparepvec.
Who it may be relevant to
Registry conditions: Cutaneous Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Pembrolizumab
    Preoperative infusions
  • Drug Talimogene Laherparepvec
    Preoperative intralesional injection

Primary outcome measures

  • Pathologic Complete Response [Time frame: 6 months]
Secondary outcome measures (1)
  • Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events [Time frame: Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Louisville — Louisville

Identifiers

NCT: NCT03842943 · 181095

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗