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Trial record 1 of 1 for:    NCT03842943
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Neoadjuvant Combination Immunotherapy for Stage III Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842943
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Egger, University of Louisville

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma Drug: Pembrolizumab Drug: Talimogene Laherparepvec Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2024


Arm Intervention/treatment
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.

Drug: Pembrolizumab
Preoperative infusions
Other Name: Keytruda

Drug: Talimogene Laherparepvec
Preoperative intralesional injection
Other Names:
  • T-VEC
  • Imlygic




Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: 6 months ]
    Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection


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 ]
    Adverse events and Serious Adverse Events will be collected



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842943


Contacts
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Contact: Michael Egger, MD 502-629-6950 michael.egger@louisville.edu

Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Michael Egger, MD University of Louisville

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Responsible Party: Michael Egger, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT03842943    
Other Study ID Numbers: 181095
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Talimogene laherparepvec
Antineoplastic Agents, Immunological
Antineoplastic Agents