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

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ClinicalTrials.gov Identifier: NCT04429321
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE June 9, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date July 2, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
Rate of serious adverse events [ Time Frame: Serious adverse events will be recorded from time of informed to consent to 100 days after the end of study intervention ]
SAE rate following embolization in patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
  • Objective response rate [ Time Frame: Measured from baseline to 6 months post initiation ]
    Objective response rate by RECIST 1.1
  • Characterization of immune cells [ Time Frame: From baseline to 12 weeks post initiation of therapy ]
    Characterization of tumor-infiltrating leukocytes in primary and metastatic lesions before and after embolotherapy
  • PD-L1 [ Time Frame: From baseline to 12 weeks post initiation of therapy ]
    Percentage of PD-L1 stain positivity in the primary tumor biopsy of participants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary
Official Title  ICMJE UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary
Brief 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.
Detailed Description Previously untreated subjects with stage 4 RCC and unresected primary tumor will undergo two cycles of combination immune checkpoint inhibition (ICI) therapy, embolization of the primary tumor, then resume ICI therapy. Study ends with safety and efficacy assessment at 6 months. Correlative blood and tissue specimens will be obtained.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Carcinoma
  • Renal Cell Carcinoma Stage IV
Intervention  ICMJE
  • Drug: Nivolumab
    Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone
    Other Name: Opdivo
  • Drug: Ipilimumab
    ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab
    Other Name: Yervoy
  • Device: bland embolization
    Lipiodol:ethanol embolization of their primary tumor
    Other Name: trans-arterial embolization
Study Arms  ICMJE Experimental: Ipilimumab +Nivolumab with Embolization

Patients receive ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 3 mg/kg 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 Lipiodol:ethanol embolization of their primary tumor and continue systemic therapy subsequently.

Interventions:
  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Device: bland embolization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2020)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Metastatic renal cell carcinoma with unresected primary tumor
  2. No prior immune checkpoint therapy
  3. Primary tumor amenable to percutaneous embolization
  4. Additional metastatic site > 1 cm assessable for response by RECIST 1.1
  5. 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:

  1. CNS metastasis
  2. 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
  3. Immunodeficiency syndrome
  4. Glucocorticoid (> 10 mg daily prednisone equivalents) or immunosuppressant therapy
  5. Active infection requiring systemic therapy
  6. 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.
  7. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  8. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  9. Contrast allergy not mitigated by usual prophylaxis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Soulen, MD 855-216-0098 michael.soulen@pennmedicine.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04429321
Other Study ID Numbers  ICMJE 843082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michale Soulen, MD University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP