NCT04429321

Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary

UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single center phase 1 trial will study the combination of nivolumab+ipilimumab with embolization in participants with renal cell carcinoma. The study will evaluate the safety of embolotherapy in patients with metastatic RCC receiving nivolumab+ipilimumab. The hypothesis is that the number of serious adverse events will be no greater than the number of serious adverse events for both therapies combined.

Detailed description

Previously untreated subjects with stage 4 RCC and unresected primary tumor or metastasis amenable to embolization will undergo two cycles of combination immune checkpoint inhibition (ICI) therapy, embolization of the target tumor, then resume ICI therapy. Study ends with safety and efficacy assessment at 6 months. Correlative blood and tissue specimens will be obtained.

Conditions

• Renal Cell Carcinoma
• Renal Cell Carcinoma Stage IV

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone
DRUG	Ipilimumab	ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab
DEVICE	bland embolization	Lipiodol:ethanol embolization of their primary or target tumor

Timeline

• Start date: 2020-08-26
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2020-06-12
• Last updated: 2024-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study