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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    68
  • sponsor
    National Cancer Institute (NCI)
Updated on 10 October 2021
cancer
lymphoma
monoclonal antibodies
systemic therapy
serum pregnancy test
measurable disease
carcinoma
anticoagulants
melanoma skin
skin cancer
squamous cell carcinoma
non-melanoma skin cancer
gilbert's syndrome
progressive disease
neutrophil count
avelumab
pet scan
tumor cells
pembrolizumab
pd-l1
nivolumab
biological therapies
biological therapy
adenocarcinoma
therapeutic agents
immunoglobulin
t-cell lymphoma
peripheral t-cell lymphoma
mycosis fungoides
sezary syndrome
anaplastic large cell lymphoma
carcinoma of skin
skin tumor
extramammary paget's disease
cemiplimab
hidradenocarcinoma
mucin
mycosis
intralesional injection
b-cell lymphomas
signet ring cell carcinoma
cutaneous t-cell lymphoma
mucinous carcinoma
merkel cell carcinoma
trichilemmal carcinoma
spiradenocarcinoma

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.

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.

After completion of study treatment, patients are followed up every 12 weeks for 3 years.

Details
Condition Basosquamous carcinoma, Basal cell carcinoma, Adenocarcinoma, Papillary adenocarcinoma, Adenoid Cystic Carcinoma, Skin appendage carcinoma, Signet ring cell carcinoma, Neuroendocrine carcinoma, Sezary Syndrome, Eccrine porocarcinoma, cutaneous T-cell lymphoma, Osteitis Deformans, Dermatosis, Lymphoproliferative Disorder, Extramammary Paget's Disease, keratoacanthoma, Merkel cell carcinoma, Vulvar Squamous Cell Carcinoma, Refractory Anaplastic Large Cell Lymphoma, Sézary Syndrome, Refractory Mycosis Fungoides, Sézary Syndrome, Cutaneous Squamous Cell Carcinoma, Congenital Skin Diseases, Skin Squamous Cell Carcinoma, Sézary Syndrome, Squamous Cell Carcinoma of Unknown Primary Origin, Sézary Syndrome, Apocrine Carcinoma, Extraocular Cutaneous Sebaceous Carcinoma, Hidradenocarcinoma, Malignant Sweat Gland Neoplasm, Microcystic Adnexal Carcinoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Primary Cutaneous Mucinous Carcinoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Spiradenocarcinoma, Stage III Skin Cancer, Stage IV Skin Cancer, Sweat Gland Carcinoma, Trichilemmocarcinoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Skin Conditions, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Malignant Adenoma, Lymphoproliferative disorders, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Squamous Cell Carcinoma of Unknown Primary, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Non-Melanomatous Lesion, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Merkel Cell Carcinoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Skin Squamous Cell Carcinoma, Refractory T-Cell Non-Hodgkin Lymphoma, Trichilemmal Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Adenoid Cystic Skin Carcinoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Cylindrocarcinoma, Digital Papillary Adenocarcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Squamoid Eccrine Ductal Carcinoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, basal cell carcinomas, basal cell carcinoma of skin, squamous cell skin cancer, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Sézary Syndrome, Sézary Syndrome, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-Positive, Endocrine Mucin-Producing Sweat Gland Carcinoma, Endocrine Mucin-Producing Sweat Gland Carcinoma, NK-Cell Lymphoma, Unclassifiable, NK-Cell Lymphoma, Unclassifiable, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma
Treatment laboratory biomarker analysis, Nivolumab, talimogene laherparepvec
Clinical Study IdentifierNCT02978625
SponsorNational Cancer Institute (NCI)
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have histologic or cytologic diagnosis of non-melanoma skin cancer (NMSC) or lymphomas other than B-cell lymphomas; as both of those terms are categories rather than specific diagnoses, specific guidance on eligible tumor types is provided below
PART I (before February 2020 amendment): Included tumor types
T cell and NK cell lymphomas, including, but not limited to: cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas
Merkel cell carcinoma
Squamous cell carcinoma of the skin, including keratoacanthomas, vulvar squamous carcinoma, and mixed histology tumors, such as basosquamous carcinoma, and squamous cell carcinoma of unknown primary consistent with skin origin
Other non-melanoma skin cancers
Basal cell carcinoma
Malignant sweat gland tumors, including porocarcinoma, hidradenocarcinoma, spiradenocarcinoma, cylindrocarcinoma, microcystic adnexal carcinoma and related entities, squamoid eccrine ductal carcinoma, cutaneous adenoid cystic carcinoma, digital papillary adenocarcinoma, primary cutaneous mucinous carcinoma, endocrine mucin-producing sweat gland carcinoma, primary cutaneous signet ring cell carcinoma, cutaneous apocrine gland carcinoma, and extraocular sebaceous carcinoma
Adnexal carcinoma
Trichilemmal carcinoma
Extramammary Paget's disease
Any other rare tumor of the skin with approval of principle investigator (PI)
PART II (after February 2020 amendment)
The Merkel cell carcinoma (MCC)-2 cohort will include patients with MCC
The squamous cell carcinoma (SCC)-2 cohort will include patients with SCC
PART I (before February 2020 amendment): Patients with T cell and natural killer (NK) cell lymphomas must be refractory to, be intolerant of, have relapsed following, or have refused all standard life-prolonging therapies
PART I (before February 2020 amendment): Patients with non-melanoma skin cancers (NMSC) must have advanced or refractory tumors
Advanced/unresectable is defined by at least 1 of the following criteria: tumors 2 cm or more, tumors considered unresectable, tumors invading deep tissues such as muscle, cartilage or bone, tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes and/or distant sites
Refractory is defined by persistent or recurrent tumor despite prior therapy consisting of at least 1 of the following: surgery, radiation therapy, intralesional therapy, topical therapy, or systemic therapy
PART I (before February 2020 amendment): Subjects must have at least 1 cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing
PART I (before February 2020 amendment): Subjects must have radiographically or clinically measurable disease, defined as at least one lesion that is >= 10 mm in diameter in at least 1 dimension, or an aggregate of lesions that measures >= 10 mm in diameter in at least 1 dimension
PART I (before February 2020 amendment): Subjects must be able and willing to undergo serial biopsies of injected lesion(s) and, when applicable and clinically feasible, non-injected lesions
PART I (before February 2020 amendment): Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
PART I (before February 2020 amendment): Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
PART I (before February 2020 amendment): Hemoglobin >= 9 g/dL without transfusion in the preceding 7 days
PART I (before February 2020 amendment): Platelets >= 75 x 10^9/L
PART I (before February 2020 amendment): Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome with a total bilirubin < 3.0 mg/dL)
PART I (before February 2020 amendment): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN
PART I (before February 2020 amendment): Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
PART I (before February 2020 amendment): Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN, unless the subject is on anticoagulant therapy; (if the subject is receiving anticoagulant therapy, PT, and activated PTT [aPTT] must be within therapeutic range of intended use of anticoagulants)
PART I (before February 2020 amendment): Talimogene laherparepvec, nivolumab and other therapeutic agents used in this trial may cause fetal harm when administered to a pregnant woman; women of child-bearing potential (WOCBP) and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence from heterosexual intercourse) prior to study entry, during the study participation, and for 7 months after the last dose of the drug; WOCBP must have a negative serum pregnancy test within 14 days prior to randomization; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree to use adequate contraception prior to study entry, during the study participation and for 7 months after the last dose of the drug
PART I (before February 2020 amendment): Ability to understand and the willingness to sign a written informed consent document
PART II (after February 2020 amendment): Subjects in expansion cohorts MCC-2 and SCC-2 must have a diagnosis of MCC or SCC, respectively
PART II (after February 2020 amendment): Subjects must have refractory disease, defined as evidence of progressive disease despite prior therapy with a PD-1 or PD-L1 blocking antibody (avelumab, pembrolizumab, nivolumab, cemiplimab, etc.); progression must have occurred during PD-1 or PD-L1 directed therapy or within 6 months of the last dose of PD-1 or PD-L1 directed therapy
PART II (after February 2020 amendment): Subjects must have at least 1 cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing
PART II (after February 2020 amendment): Subjects must have radiographically or clinically measurable disease, defined as at least one lesion that is >= 10 mm in diameter in at least 1 dimension, or an aggregate of lesions that measures >= 10 mm in diameter in at least 1 dimension
PART II (after February 2020 amendment): Subjects must be able and willing to undergo serial biopsies of injected lesion(s) and, when applicable and clinically feasible, non-injected lesions
PART II (after February 2020 amendment): ECOG performance status =< 2 (Karnofsky >= 60%)
PART II (after February 2020 amendment): Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
PART II (after February 2020 amendment): Hemoglobin >= 9 g/dL without transfusion in the preceding 7 days
PART II: P (after February 2020 amendment): Platelets >= 75 x 10^9/L
PART II (after February 2020 amendment): Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Patients with Gilbert's Syndrome with a total bilirubin < 3.0 mg/dL.)
PART II (after February 2020 amendment): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN
PART II (after February 2020 amendment): Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
PART II (after February 2020 amendment): Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN, unless the subject is on anticoagulant therapy; (if the subject is receiving anticoagulant therapy, PT, and aPTT must be within therapeutic range of intended use of anticoagulants)
PART II (after February 2020 amendment): Talimogene laherparepvec, nivolumab and other therapeutic agents used in this trial may cause fetal harm when administered to a pregnant woman; women of child-bearing potential (WOCBP) and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence from heterosexual intercourse) prior to study entry, during the study participation, and for 7 months after the last dose of the drug; WOCBP must have a negative serum pregnancy test within 14 days prior to randomization; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree to use adequate contraception prior to study entry, during the study participation and for 7 months after the last dose of the drug
PART II (after February 2020 amendment): Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Excluded tumor types
Melanoma
Bone sarcomas
Soft tissue sarcomas, including angiosarcoma, primary cutaneous leiomyosarcoma, dermatofibrosarcoma protuberans
Leukemias
Myeloid sarcoma, leukemia cutis, and chloroma
Hodgkin's lymphoma
B cell lymphoma
Patients who have had systemic therapy or radiotherapy within 3 weeks prior to the first dose of study therapy
Untreated central nervous system (CNS) involvement; patients with known brain metastases are eligible if they have been treated and are stable in the view of the treating investigator
Previous treatment with talimogene laherparepvec or other herpes virus based therapy; (prior therapy with checkpoint inhibitors and/or other immunotherapy is allowed)
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1 excepting alopecia, peripheral sensory neuropathy, and stable endocrine insufficiencies such as thyroid and adrenal insufficiency)
Second primary malignancy, only if it would affect the safety of the treatment or the subject's ability to complete study-related procedures
History or evidence of active autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other); or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) within 2 months of enrollment; (replacement therapy [e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency] is not considered a form of systemic treatment for autoimmune disease)
Evidence of clinically significant immunosuppression such as the following
Primary immunodeficiency state such as severe combined immunodeficiency disease
Receiving systemic immunosuppressive therapy including prednisone > 10 mg per day (or equivalent), tacrolimus, everolimus, sirolimus, mycophenolate mofetil, etanercept, infliximab, etc
Recipients of solid organ, bone marrow, or stem cell transplants; auto transplant recipients are allowed
Notes: Oral steroid doses =< 10 mg/day of prednisone (or equivalent) are not considered immunosuppressive and are permitted; inhaled and intraarticular corticosteroids are permitted
Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis)
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use
Other viral infections
Known to have acute or chronic active hepatitis B or hepatitis C infection
Known to have human immunodeficiency virus (HIV) infection
Prior therapy with viral-based tumor vaccine
Received live vaccine within 28 days prior to enrollment
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus 1 (HSV-1) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 7 months after the last dose of treatment; female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 7 months after the last dose of treatment; sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to talimogene laherparepvec or any of its components or nivolumab, or history of severe hypersensitivity reaction to any monoclonal antibody
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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