Nivolumab + Ipilimumab + Embolization for Renal Cell Carcinoma

Overseen by Michale Soulen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Abramson Cancer Center of the University of Pennsylvania

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michale Soulen, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

Any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial

You have a weakened immune system.

You have an allergy to contrast dye that cannot be controlled with standard preventive measures.

Treatment Details

Interventions

• Embolization (Procedure)
• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Ipilimumab +Nivolumab with Embolization Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center of the University of Pennsylvania

Chief Executive Officer since 2017

DPhil in Immunology from Oxford University, MD from Harvard Medical School

Dr. Lawrence N. Shulman

Abramson Cancer Center of the University of Pennsylvania

Chief Medical Officer since 2017

MD from Harvard Medical School

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania