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

NCT04429321 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Michale Soulen, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429321 on ClinicalTrials.gov