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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02978625
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Positron Emission Mammography — PROCEDURE
    Undergo PET/CT
  • Talimogene Laherparepvec — BIOLOGICAL
    Given IT

Study Details

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.

Key Dates

Start date
Sep 27, 2017
Status verified
Feb 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (talimogene laherparepvec, nivolumab)
    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.

Primary Outcome Measure

Response rate to talimogene laherparepvec alone (Part I) [ Time Frame: Up to 1 year ]

Locations (36)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCHealth University of Colorado HospitalAuroraColorado80045-
UM Sylvester Comprehensive Cancer Center at AventuraAventuraFlorida33180-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Roswell Park Cancer InstituteBuffaloNew York14263-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Los Angeles, CA

By research site
Los Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAKeck Medical Center of USC Pasadena· Pasadena, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCHealth University of Colorado Hospital· Aurora, CO

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