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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

Metastatic renal cell carcinoma with unresected primary tumor or with metastasis amenable to embolization

Primary tumor or metastasis amenable to percutaneous embolization per review by the treating interventional oncologist

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have kidney cancer that has spread and cannot be removed with surgery, or the spread can be treated with a procedure called embolization.

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Your tumor can be treated using a procedure called percutaneous embolization, according to your oncologist.

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You have more than one large area of cancer spread that can be measured for treatment response.

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You have not received any immune checkpoint therapy before.

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You have a blood vessel feeding the tumor that is larger than 2 millimeters in diameter and does not have a visible abnormal connection between an artery and a vein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from baseline to 6 months post initiation

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

~2620

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,094 Total Patients Enrolled

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,694 Total Patients Enrolled

Michale Soulen, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this trial available at the moment?

"The current status of the clinical trial is recruiting, according to information provided on clinicaltrials.gov. It was initially announced on August 26th 2020 and subsequently updated most recently in March 14th 2022."

Answered by AI

To what degree could bland embolization pose a hazard to patients?

"Due to the limited data collected in Phase 1 trials, our team at Power rated bland embolization safety a score of 1."

Answered by AI

What is the aggregate participant count of this healthcare experiment?

"Affirmative. According to clinicaltrials.gov, this trial is in the process of recruiting participants with an initial posting on August 26th 2020 and a recently updated version posted on March 14th 2022. 22 individuals are sought from 1 particular facility."

Answered by AI

What health conditions does bland embolization typically address?

"Bland embolization is frequently deployed to address the effects of anti-angiogenic therapy. In addition, it can be used to treat certain malignant neoplasms, melanomas that are inoperable and squamous cell carcinoma."

Answered by AI

What other research endeavors have focused on bland embolization?

"Presently, 86 Phase 3 trials for bland embolization are ongoing and 764 of these clinical studies remain active. Although the majority of them originate from Pittsburgh, Pennsylvania, a total of 42760 sites offer this type of medical research."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Nivolumab Plus Ipilimumab Versus Sunitinib in Advanced Renal-cell Carcinoma

Motzer, Robert J., Nizar M. Tannir, David F. McDermott, Osvaldo Arén Frontera, Bohuslav Melichar, Toni K. Choueiri, Elizabeth R. Plimack, et al.. 2018. “Nivolumab Plus Ipilimumab Versus Sunitinib in Advanced Renal-cell Carcinoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1712126.

British Journal of CancerJournal

Efficient Loading of Dendritic Cells Following Cryo and Radiofrequency Ablation in Combination with Immune Modulation Induces Anti-tumour Immunity

den Brok, M H M G M, R P M Sutmuller, S Nierkens, E J Bennink, C Frielink, L W J Toonen, O C Boerman, C G Figdor, T J M Ruers, and G J Adema. 2006. “Efficient Loading of Dendritic Cells Following Cryo and Radiofrequency Ablation in Combination with Immune Modulation Induces Anti-tumour Immunity”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/sj.bjc.6603341.

Urologia InternationalisJournal

Does Radical Nephrectomy with Immunochemotherapy Have Any Superiority over Embolization Alone in Metastatic Renal Cell Carcinoma?

Demirci, Deniz, Atila Tatlışen, Oğuz Ekmekçioğlu, Nevzat Özcan, and Reşat Kaya. 2004. “Does Radical Nephrectomy with Immunochemotherapy Have Any Superiority over Embolization Alone in Metastatic Renal Cell Carcinoma?”. Urologia Internationalis. S. Karger AG. doi:10.1159/000078805.

OncoImmunologyJournal