A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma
CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic cells, which have been co-electroporated with both in vitro transcribed (IVT) RNA from an autologous tumor specimen and CD40L RNA. CMN-001 is indicated for treatment of intermediate/poor risk patients with advanced renal cell carcinoma (RCC) in combination with nivolumab plus ipilimumab as first line therapy and in combination with lenvatinib plus everolimus as 2nd line therapy post 1st line failure.
1. To evaluate CMN-001 in a randomized trial between SOC (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-00. 2. To compare safety assessments between study arms. 3. To compare progression free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1 and iRECIST, optimized for immunotherapy trials) between study arms. 4. To compare tumor responses based on RECIST 1.1 and iRECIST between study arms
Advanced disease histologically assessed as RCC, with predominantly clear cell histology
Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of study participation per iRECIST
Subjects who are candidates for standard first-line therapy
Time from initial RCC diagnosis to initiation of systemic treatment (Nivolumab+Ipilimumab) of > Karnofsky Performance Status (KPS) > 70%
Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Adequate hematologic function, as defined by protocol
Adequate coagulation function as defined by protocol
Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
Normal ECG or clinically non-significant finding(s) at Screening, in the Investigator's opinion
Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA.
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
Patients will be excluded if they have > Time from diagnosis to systemic treatment > Hgb > Corrected calcium > 10.0 mg/dL
KPS > Neutrophils > ULN
Platelets > ULN
NCI CTCAE Grade 3 hemorrhage > Clinically significant cardiovascular conditions within 3 months prior to Randomization
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