Purpose

This phase II trial studies how well axitinib and nivolumab work in treating patients with TFE/translocation renal cell carcinoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating patients with TFE/translocation renal cell carcinoma compared to standard treatment, including surgery, chemotherapy, or immunotherapy.

Category

IRB Number
20190114HU
NCT Number
NCT03595124
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Regulatory Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Regulatory Point of Contact
Anne-Marie Langevin
(210) 567-7460
langevin@uthscsa.edu



Eligibility

Eligible Ages
Over 12 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Metastatic Renal Cell Carcinoma
    2. Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
    3. Stage III Renal Cell Cancer AJCC v8
    4. Stage IV Renal Cell Cancer AJCC v8
    5. Unresectable Renal Cell Carcinoma
    6. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm B (axitinib)

      Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)
    7. Drug: Axitinib

      Given PO

      Other names:

      • AG-013736
      • AG013736
      • Inlyta

    8. Experimental

      Arm A (axitinib, nivolumab)

      Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
    9. Drug: Axitinib

      Given PO

      Other names:

      • AG-013736
      • AG013736
      • Inlyta

    10. Biological: Nivolumab

      Given IV

      Other names:

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

    11. Experimental

      Arm C (nivolumab)

      Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
    12. Biological: Nivolumab

      Given IV

      Other names:

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