Purpose

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Category

IRB Number
20170129HU
NCT Number
NCT03055013
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Michael Liss

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Michael Liss
(210) 567-0046
liss@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      Single (Outcomes Assessor)
      Condition
    1. Metastatic Renal Cell Carcinoma
    2. Sarcomatoid Renal Cell Carcinoma
    3. Stage II Renal Cell Cancer AJCC v7
    4. Stage III Renal Cell Cancer AJCC v7
    5. Unclassified Renal Cell Carcinoma
    6. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm I (nivolumab, nephrectomy)

      Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
    7. Procedure: Conventional Surgery

      Undergo nephrectomy

    8. Other: Questionnaire Administration

      Ancillary studies

    9. Biological: Nivolumab

      Given IV

      Other names:

      • BMS-936558
      • MDX-1106
      • NIVO
      • ONO-4538
      • Opdivo

    10. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment

    11. Active Comparator

      Arm II (nephrectomy)

      Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.
    12. Procedure: Conventional Surgery

      Undergo nephrectomy

    13. Other: Patient Observation

      Undergo observation

      Other names:

      • Active Surveillance
      • deferred therapy
      • expectant management
      • Observation
      • Watchful Waiting

    14. Other: Questionnaire Administration

      Ancillary studies

    15. Other: Quality-of-Life Assessment

      Ancillary studies

      Other names:

      • Quality of Life Assessment