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Checkpoint Inhibitor

Nivolumab + Ipilimumab + Embolization for Renal Cell Carcinoma

Phase 1
Waitlist Available
Led By Michale Soulen, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from baseline to 6 months post initiation
Awards & highlights

Study Summary

This trial will study the safety of combining nivolumab+ipilimumab with embolization in patients with metastatic renal cell carcinoma.

Who is the study for?
This trial is for adults over 18 with stage 4 kidney cancer that hasn't spread too much and can be targeted by embolization. They should have good organ function, no prior immune therapy, and agree to use effective contraception. People with immune deficiencies, untreated brain metastasis, severe allergies to contrast dye, or certain autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study tests combining Nivolumab and Ipilimumab (immune therapies) with a procedure called bland embolization on patients with renal cell carcinoma. It aims to see if this mix increases serious side effects compared to what's expected from each treatment alone.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapies like fatigue, skin issues, inflammation of organs (like the intestines or liver), hormonal imbalances, as well as complications from the embolization procedure such as pain at the injection site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from baseline to 6 months post initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from baseline to 6 months post initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of serious adverse events
Secondary outcome measures
Characterization of immune cells
Objective response rate
PD-L1

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ipilimumab +Nivolumab with EmbolizationExperimental Treatment3 Interventions
Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities. Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,043 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
388 Previous Clinical Trials
145,668 Total Patients Enrolled
Michale Soulen, MDPrincipal InvestigatorUniversity of Pennsylvania
~0 spots leftby Jun 2025
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