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

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    22
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 31 January 2021

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.

Description

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.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Cancer, Stage IV Renal Cell Cancer, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Renal Cell Carcinoma Stage IV, clear cell renal cell carcinoma, stage iv kidney cancer
Treatment Ipilimumab, Nivolumab, Bland Embolization
Clinical Study IdentifierNCT04429321
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on31 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Metastatic renal cell carcinoma with unresected primary tumor or with metastasis amenable to embolization
No prior immune checkpoint therapy
Primary tumor or metastasis amenable to percutaneous embolization per review by the treating interventional oncologist
Patent feeding artery to tumor > 2 mm diameter without macroscopic
arteriovenous fistula/shunt
\. Additional metastatic site > 1 cm assessable for response by RECIST 1.1
\. Adequate organ function by screening laboratory studies within 30 days of
embolization
platelets > 50K, correctable by transfusion
INR < 1.5, correctable by transfusion
creatinine < 2.0 6. ECOG performance status 0-2 7. Age 18 years 8. Have signed the current approved informed consent form and be willing and able to comply with this protocol 9. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of study drug 10. Women of childbearing potential must have a negative serum or urine pregnancy test 11. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose

Exclusion Criteria

Untreated CNS metastasis
Autoimmune disorder; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment
Immunodeficiency syndrome
Glucocorticoid (> 10 mg daily prednisone equivalents) or immunosuppressant therapy
Active infection requiring systemic therapy
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
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Contrast allergy not mitigated by usual prophylaxis
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