Clinical Trials /

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

NCT03842943

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.

Related Conditions:
  • Cutaneous Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Combination Immunotherapy for Stage III Melanoma
  • Official Title: Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Clinical Trial IDs

  • ORG STUDY ID: 181095
  • NCT ID: NCT03842943

Conditions

  • Cutaneous Melanoma

Interventions

DrugSynonymsArms
PembrolizumabKeytrudaCombination T-VEC/Pembrolizumab
Talimogene LaherparepvecT-VEC, ImlygicCombination T-VEC/Pembrolizumab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Combination T-VEC/PembrolizumabExperimentalPre-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.
  • Pembrolizumab
  • Talimogene Laherparepvec

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic Complete Response
Time Frame:6 months
Safety Issue:
Description:Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Adverse events and Serious Adverse Events will be collected

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Louisville

Last Updated

September 5, 2020