Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
Kidney Cancer
Unknown Primary
18 Years and older, Male and Female
CMN-001-1 (primary)
NCI-2020-07747
Summary
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.
Eligibility
- Age = 18 years
- 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 <1 year
- 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 central laboratory values for all three of the following criteria:
- Absolute neutrophil count (ANC) LLN, and
- Platelets 75,000/mm3 or 75.0 x 109/L, and
- Hemoglobin (Hgb) 8.0 g/dL
- Adequate renal function, as defined by either of the following criteria:
- Serum creatinine 1.5 x upper limit of normal (ULN),
- OR, if serum creatinine greater than 1.5 x ULN, estimated glomerular filtration rate (eGFR) 30 mL/min
- Adequate hepatic function, as defined by both of the following:
- Total serum bilirubin 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN or, AST and ALT 5 x ULN if liver function abnormalities are due to underlying malignancy
- Adequate coagulation function as defined by either of the following criteria:
- INR < 1.5 x ULN
- For subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these patients may exceed 1.5 x ULN if that is the goal of anticoagulant therapy.
- 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
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