Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention 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: - To determine the feasibility of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Secondary Objectives: To determine the clinical outcome (overall response rate (ORR), progressive free survival (PFS), overall survival (OS)) in metastatic renal cell...
Primary Objective: - To determine the feasibility of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Secondary Objectives: To determine the clinical outcome (overall response rate (ORR), progressive free survival (PFS), overall survival (OS)) in metastatic renal cell carcinoma patients treated with intermittent nivolumab therapy. To evaluate the toxicity of intermittent nivolumab therapy in patients with metastatic renal cell carcinoma. Correlative Objective - Investigate correlations between baseline and post-treatment immunomodulatory cells [specifically, myeloid-derived suppressor cells (MDSC) regulatory T cells (Treg), cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8), T Cells, T-cell receptor (TCR) repertoire and time off therapy.
Tracking Information
- NCT #
- NCT03126331
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Moshe C. Ornstein, MD, MA Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center