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Clinical Trial Summary

This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and nivolumab may work better compared to usual treatments in treating patients with lymphomas or non-melanoma skin cancers.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the frequency of patients responding (response rate) to talimogene laherparepvec monotherapy. SECONDARY OBJECTIVES: I. To determine the local response rate to talimogene laherparepvec in injected tumors. II. To determine the response rate to talimogene laherparepvec + nivolumab (NIVO). III. To identify potential pre-treatment and on-treatment correlative biomarkers of local and systemic immune response. OUTLINE: Patients receive talimogene laherparepvec intratumorally (IT) and nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for cycle 1 then every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or positron emission tomography (PET)/CT scan on study. Patients also undergo blood sample collection and biopsies on study. After completion of study treatment, patients are followed up every 12 weeks for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Papillary
  • Adnexal Carcinoma
  • Anaplastic Large Cell Lymphoma, ALK-Negative
  • Anaplastic Large Cell Lymphoma, ALK-Positive
  • Apocrine Carcinoma
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Basal Cell
  • Carcinoma, Ductal
  • Carcinoma, Merkel Cell
  • Carcinoma, Squamous Cell
  • Digital Papillary Adenocarcinoma
  • Endocrine Mucin-Producing Sweat Gland Carcinoma
  • Extramammary Paget Disease
  • Hidradenocarcinoma
  • Keratoacanthoma
  • Lymphoma
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Malignant Sweat Gland Neoplasm
  • Merkel Cell Carcinoma
  • Microcystic Adnexal Carcinoma
  • Mycoses
  • Mycosis Fungoides
  • NK-Cell Lymphoma, Unclassifiable
  • Paget Disease, Extramammary
  • Papillary Adenocarcinoma
  • Porocarcinoma
  • Primary Cutaneous Mucinous Carcinoma
  • Recurrence
  • Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Merkel Cell Carcinoma
  • Refractory Mycosis Fungoides
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Skin Squamous Cell Carcinoma
  • Refractory T-Cell Non-Hodgkin Lymphoma
  • Sezary Syndrome
  • Skin Basal Cell Carcinoma
  • Skin Basosquamous Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Squamoid Eccrine Ductal Carcinoma
  • Squamous Cell Carcinoma of Unknown Primary
  • Sweat Gland Carcinoma
  • Trichilemmal Carcinoma
  • Vulvar Squamous Cell Carcinoma

NCT number NCT02978625
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 27, 2017
Completion date September 1, 2025

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