Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Melanoma
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Evaluate the overall response rates of pembrolizumab (MK-3475) combined with lymphodepletion, TIL and high or low dose aldesleukin (interleukin-2) therapy in patients with metastatic melanoma. SECONDARY OBJECTIVES: I. Comparison of progression free survival between the treatme...
PRIMARY OBJECTIVES: I. Evaluate the overall response rates of pembrolizumab (MK-3475) combined with lymphodepletion, TIL and high or low dose aldesleukin (interleukin-2) therapy in patients with metastatic melanoma. SECONDARY OBJECTIVES: I. Comparison of progression free survival between the treatment arms. II. Comparison of overall survival between the treatment arms. III. Comparison of deep tumor responses (defined as over 60% reduction in tumor burden) between the treatment arms as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. IV. Number of complete responses in both treatment arms. V. Safety evaluations by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4. EXPLORATORY OBJECTIVES: I. Identification of biomarkers predictive of treatment response or failure through immunohistochemistry, flow cytometry, gene expression changes as assessed by NanoString codeset, neo-antigen identification and complementary determining region (CDR)3 sequencing from blood and tumor samples acquired from baseline and on-treatment samples. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard lymphodepleting chemotherapy comprising of cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6 followed by fludarabine phosphate IV piggyback (IVPB) over 15-30 minutes on days -5 to -1. Patients also receive therapeutic tumor infiltrating lymphocytes IV over 15-60 minutes on day 0 followed by high-dose aldesleukin IV over 15 minutes every 8-16 hours for up to 15 doses on days 1-5. Beginning between 21-28 days after TIL infusion, patients receive maintenance therapy comprising of pembrolizumab IV over 30 minutes every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard lymphodepleting chemotherapy comprising of cyclophosphamide, fludarabine phosphate, and therapeutic tumor infiltrating lymphocytes as in Arm I, followed approximately 6 hours later by low-dose aldesleukin subcutaneously (SC) once per day (QD) for 14 days. Patients also receive pembrolizumab as in Arm I. After completion of study treatment, patients are followed up every 3 months.
Tracking Information
- NCT #
- NCT02500576
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rodabe N Amaria M.D. Anderson Cancer Center