NCT03203473

Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)

Phase II Study of Optimized Management of NIVOlumab Based on REsponse in Patients With Advanced Renal Cell Carcinoma (OMNIVORE Study)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Toni Choueiri, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying two drugs at different time points as a possible treatment for advanced renal cell cancer The drugs involved in this study are: Nivolumab Ipilimumab

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the intervention is being studied. Nivolumab and ipilimumab are antibodies (a type of human protein) that work to stimulate your body's immune system to fight tumor cells. The FDA (the U.S. Food and Drug Administration) has approved nivolumab as a treatment option for this disease; however, the FDA has not approved the way nivolumab and ipilimumab are being administered in this study. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. This study is being done to evaluate nivolumab treatment strategies based on each patients individual response to treatment. In participants who have a response to treatment, nivolumab will be stopped and participants will be closely monitored. In participants who do not have a response to treatment,the investigators will investigate whether the addition of ipilimumab improves a participant response to treatment. Participant blood and tissue samples will be collected to learn about how certain biomarkers and genes relate to participant outcomes.

Conditions

• Renal Cancer

Interventions

Type	Name	Description
DRUG	Ipilimumab	YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells
DRUG	Nivolumab	Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs

Timeline

• Start date: 2017-10-26
• Primary completion: 2021-11-30
• Completion: 2026-06-28
• First posted: 2017-06-29
• Last updated: 2026-02-06
• Results posted: 2022-04-25

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study