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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Renal Cell Carcinoma Stage IV Drug: Nivolumab Drug: Ipilimumab Device: bland embolization Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Measured from baseline to 6 months post initiation ]
    Objective response rate by RECIST 1.1

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429321


Contacts
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Contact: Michael Soulen, MD 855-216-0098 michael.soulen@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Michale Soulen, MD University of Pennsylvania
Publications:

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04429321    
Other Study ID Numbers: 843082
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents