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

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.

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Negative
• Anaplastic Large Cell Lymphoma, ALK-Positive
• Apocrine Carcinoma
• Carcinoma Arising From Cylindroma
• Carcinoma Arising From Spiradenoma
• Digital Papillary Adenocarcinoma
• Endocrine Mucin-Producing Sweat Gland Carcinoma
• Extramammary Paget Disease
• Extraocular Sebaceous Carcinoma
• Hidradenocarcinoma
• Malignant Sweat Gland Neoplasm
• Merkel Cell Carcinoma
• Microcystic Adnexal Carcinoma
• NK-Cell Lymphoma, Unclassifiable
• Papillary Adenocarcinoma
• Porocarcinoma
• Primary Cutaneous Mucinous Carcinoma
• 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
• Signet Ring Cell Adenocarcinoma
• Skin Adenoid Cystic Carcinoma
• Skin Adnexal Carcinoma
• Skin Basal Cell Carcinoma
• Skin Basosquamous Cell Carcinoma
• Skin Keratoacanthoma
• Skin Squamous Cell Carcinoma
• Squamoid Eccrine Ductal Carcinoma
• Squamous Cell Carcinoma of Unknown Primary
• Sweat Gland Carcinoma
• Trichilemmal Carcinoma
• Vulvar Squamous Cell Carcinoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Mammography

Undergo PET/CT

BIOLOGICAL

Talimogene Laherparepvec

Given IT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Ann (Annie) W Silk · Dana-Farber - Harvard Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-27

Primary Completion

2027-09-01

Completion

2027-09-01

FDA Drug

Yes

Countries

• United States

Study Locations