A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy

Status Not yet recruiting

Clinical Trial Summary

To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied.

Clinical Trial Description

Primary Objectives: - To determine the objective response rate (Partial Response (PR) and Complete Response (CR)) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade Detail the primary protocol objectives. Secondary Objectives: - To describe the adverse events associated with evolocumab and administered with nivolumab - To determine the disease control rate (Stable Disease (SD)/PR/CR) based on RECIST 1.1 and iRECIST criteria - To determine duration of response in patients who achieve response - To determine progression free survival based on RECIST 1.1 criteria and iRECIST criteria - To determine 1-year survival rates and overall survival Exploratory Objectives: - To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment - To evaluate plasma low-density lipoproteins (LDL) cholesterol levels and circulating Proprotein convertase subtilisin/kexin type 9 (PSCK9) levels at baseline and on treatment - To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment - To evaluate circulating tumor cells and changes on treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06284564
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Eric Jonasch, MD
Phone	(713) 563-7232
Email	ejonasch@mdanderson.org
Status	Not yet recruiting
Phase	Phase 2
Start date	September 30, 2024
Completion date	October 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms