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(904) 244-0411

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

  • Status
    Accepting Candidates
  • Age
    18 Years - 100 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this study is to determine if the investigational study drug, XL092, in combination with nivolumab is effective in treating unresectable, locally advanced or metastatic non-clear renal cell carcinoma compared with sunitinib alone among patients who have never received systematic anticancer treatment. If you join this study, you will receive an investigational drug called XL092 (100 mg orally [po], once daily [qd]) plus nivolumab (480 mg intravenously [IV, directly into a vein], every 4 weeks [q4w]) or sunitinib (50 mg po qd) for 4 weeks, followed by 2 weeks off, continuously.

Details

Protocol number XL092-304

Eligibility

Inclusion criteria:

  1. Histologically confirmed unresectable, locally advanced or metastatic non-clear renal cell carcinoma
  2. Adequate organ and marrow function based upon laboratory tests completed within 14 days of randomization in the study.

Exclusion criteria:

1. Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC 2. Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents 3. Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible 5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before randomization.  6. Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) and platelet inhibitors (eg, clopidogrel).

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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