Spots Global Cancer Trial Database for Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
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Trial Identification
Brief Title: Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
Official Title: 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
Study ID: NCT02978625
Conditions
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Keck Medical Center of USC Pasadena, Pasadena, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Ann (Annie) W Silk
Affiliation: Dana-Farber - Harvard Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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