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Active Not RecruitingNCT02978625

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
68 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiopsy ProcedureUndergo tissue biopsy
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREComputed TomographyUndergo CT
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALNivolumabGiven IV
PROCEDUREPositron Emission MammographyUndergo PET/CT
BIOLOGICALTalimogene LaherparepvecGiven IT

Timeline

Start date
2017-09-27
Primary completion
2027-09-01
Completion
2027-09-01
First posted
2016-12-01
Last updated
2026-04-13

Locations

36 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02978625. Inclusion in this directory is not an endorsement.