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Nivolumab

Talimogene laherparepvec

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive talimogene laherparepvec IT and nivolumab 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, CT scan or PET/CT on study. Patients also undergo blood sample collection and biopsies on study.

Biopsy

Biospecimen Collection

Computed Tomography

Laboratory Biomarker Analysis

Positron Emission Mammography

Talimogene Laherparepvec

Ann (Annie) W Silk

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.

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.

Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

A Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors

Will be analyzed using descriptive statistics. A test of proportions will be performed.

Will be analyzed using descriptive statistics. Logistic regression of response rate on the variable will be performed.

Will be analyzed using descriptive statistics. Test of proportions and logistic regression will be performed.

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Will be defined as complete response or partial response lasting \>= 6 months.

Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers	NCT02978625	Adenoid Cystic ... Adnexal Carcino... Anaplastic Larg... Anaplastic Larg... Apocrine Carcin... Cylindrocarcino... Digital Papilla... Endocrine Mucin... Extramammary Pa... Extraocular Cut... Hidradenocarcin... Keratoacanthoma Malignant Sweat... Merkel Cell Car... Microcystic Adn... NK-Cell Lymphom... Papillary Adeno... Porocarcinoma Primary Cutaneo... Recurrent Matur... Recurrent T-Cel... Refractory Anap... Refractory Matu... Refractory Merk... Refractory Myco... Refractory Prim... Refractory Skin... Refractory T-Ce... Sezary Syndrome Signet Ring Cel... Skin Basal Cell... Skin Basosquamo... Skin Squamous C... Spiradenocarcin... Squamoid Eccrin... Squamous Cell C... Sweat Gland Car... Trichilemmal Ca... Vulvar Squamous...	Biopsy Biospecimen Col... Computed Tomogr... Laboratory Biom... Nivolumab Positron Emissi... Talimogene Lahe...	18 Years -	National Cancer Institute (NCI)
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers	NCT02978625	Adenoid Cystic ... Adnexal Carcino... Anaplastic Larg... Anaplastic Larg... Apocrine Carcin... Cylindrocarcino... Digital Papilla... Endocrine Mucin... Extramammary Pa... Extraocular Cut... Hidradenocarcin... Keratoacanthoma Malignant Sweat... Merkel Cell Car... Microcystic Adn... NK-Cell Lymphom... Papillary Adeno... Porocarcinoma Primary Cutaneo... Recurrent Matur... Recurrent T-Cel... Refractory Anap... Refractory Matu... Refractory Merk... Refractory Myco... Refractory Prim... Refractory Skin... Refractory T-Ce... Sezary Syndrome Signet Ring Cel... Skin Basal Cell... Skin Basosquamo... Skin Squamous C... Spiradenocarcin... Squamoid Eccrin... Squamous Cell C... Sweat Gland Car... Trichilemmal Ca... Vulvar Squamous...	Biopsy Biospecimen Col... Computed Tomogr... Laboratory Biom... Nivolumab Positron Emissi... Talimogene Lahe...	18 Years -	National Cancer Institute (NCI)

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