Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT03842943
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Preoperative infusions
  • Talimogene Laherparepvec — DRUG
    Preoperative intralesional injection

Study Details

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.

Key Dates

Start date
Jul 3, 2019
Status verified
Apr 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 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.

Primary Outcome Measure

Pathologic Complete Response [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Stacy Baum
[email protected]
502-562-4370

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University of Louisville· Louisville, KY

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