Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adenoid Cystic Skin Carcinoma
- Adnexal Carcinoma
- Microcystic Adnexal Carcinoma
- NK-Cell Lymphoma, Unclassifiable
- Se?zary Syndrome
- Refractory Merkel Cell Carcinoma
- Refractory Skin Squamous Cell Carcinoma
- Anaplastic Large Cell Lymphoma, ALK-negative
- Malignant Sweat Gland Neoplasm
- Anaplastic Large Cell Lymphoma, ALK-Positive
- Sweat Gland Carcinoma
- Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Keratoacanthoma
- Recurrent T-Cell Non-Hodgkin Lymphoma
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Apocrine Carcinoma
- Cylindrocarcinoma
- Digital Papillary Adenocarcinoma
- Skin Basal Cell Carcinoma
- Endocrine Mucin-Producing Sweat Gland Carcinoma
- Extramammary Paget Disease
- Extraocular Cutaneous Sebaceous Carcinoma
- Hidradenocarcinoma
- Primary Cutaneous Mucinous Carcinoma
- Spiradenocarcinoma
- Merkel Cell Carcinoma
- Papillary Adenocarcinoma
- Refractory Anaplastic Large Cell Lymphoma
- Porocarcinoma
- Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
- Squamous Cell Carcinoma of Unknown Primary
- Refractory Mycosis Fungoides
- Refractory T-Cell Non-Hodgkin Lymphoma
- Skin Basosquamous Cell Carcinoma
- Trichilemmal Carcinoma
- Vulvar Squamous Cell Carcinoma
- Squamoid Eccrine Ductal Carcinoma
- Signet Ring Cell Carcinoma
- Skin Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 laherparepve...
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.
Tracking Information
- NCT #
- NCT02978625
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ann (Annie) W Silk Dana-Farber - Harvard Cancer Center LAO
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