Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Capecitabine

Nivolumab

Ipilimumab

Ethanol

Ethiodized Oil

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone

ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab

Lipiodol:ethanol embolization of their primary or target tumor

bland embolization

Michale Soulen, MD

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.

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.

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

SAE rate following embolization in patients

Characterization of tumor-infiltrating leukocytes in primary and metastatic lesions before and after embolotherapy

Percentage of PD-L1 stain positivity in the primary tumor biopsy of participants

Abramson Cancer Center at Penn Medicine

Symptoms and General Pathology

Neoplasm Metastasis

Neuroendocrine Tumors

Neoplastic Processes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.

Lobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.

Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated.

Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis

Bland Embolization

Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.

Transarterial chemoembolization

CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.

Drug Eluting Beads Embolization

Michael C Soulen, MD, FSIR

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver

Hepatic progression-free interval (H-PFS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary	NCT04429321	Renal Cell Carc... Renal Cell Carc...	Nivolumab Ipilimumab bland embolizat...	18 Years -	Abramson Cancer Center at Penn Medicine
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver	NCT02724540	Neuroendocrine ... Liver Metastase...	Bland Embolizat... Transarterial c... Drug Eluting Be...	18 Years -	Abramson Cancer Center at Penn Medicine
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases To The Liver	NCT02724540	Neuroendocrine ... Liver Metastase...	Bland Embolizat... Transarterial c... Drug Eluting Be...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for bland embolization