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Clinical Trial 21083

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04203901

Phase: Phase II
Principal Investigator: Chahoud, Jad

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma

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.

Objective

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

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

BMS-936558 (Nivolumab); CMN-001 (); E7080 (Lenvatinib); Ipilimumab (); Lenvatinib (Lenvima); Nivolumab (Opdivo); Yervoy (Ipilimumab); everolimus (RAD001)

Inclusion Criteria

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

Time from initial RCC diagnosis to initiation of randomized study treatment of > Subjects who are candidates for standard first line therapy initiating with nivolumad + ipilimumab

Subjects who have initiated first line therapy with nivolumab+ipilimumab within 3 monthsof Randomization are eligible for the treatment study if all of the following conditions are met: Has no documented Disease Progression per RECIST 1.1 since initiation of nivolumab+ipilimumab; Has not had a decline of Karnofsky performance status (KPS) > 20% since initiation of nivolumab+ipilimumab; Is judged by the investigator to be tolerating nivolumab+ipilimumab

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

Exclusion Criteria

Prior systemic therapy 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 with less than 2 Heng risk factors as follows:

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

Additional criteria will apply

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