<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03035630</url>
  </required_header>
  <id_info>
    <org_study_id>HCRN GU15-223</org_study_id>
    <nct_id>NCT03035630</nct_id>
  </id_info>
  <brief_title>Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma</brief_title>
  <official_title>Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guru Sonpavde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoosier Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoosier Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, randomized phase II trial. Eligible subjects will be randomized in a&#xD;
      1:1 ratio and stratified for known prognostics variables to one of two first-line medication&#xD;
      treatment arms. Once disease progression has been documented, and following a required&#xD;
      inter-line washout period, subjects will receive either second-line medication treatment or&#xD;
      discontinue treatment, per discretion of treating investigator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to&#xD;
      one of two arms:&#xD;
&#xD;
      FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:&#xD;
&#xD;
        -  Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle&#xD;
           until documented disease progression per Immune-related Response Evaluation Criteria In&#xD;
           Solid Tumors (irRECIST) 1.1&#xD;
&#xD;
      SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:&#xD;
&#xD;
        -  Following completion of an inter-line washout period of a minimum of 2 weeks up to a&#xD;
           maximum of 60 days (or at the discretion of treating investigator) subjects will&#xD;
           receive:&#xD;
&#xD;
             -  Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until&#xD;
                documented disease progression per Response Evaluation Criteria In Solid Tumors&#xD;
                (RECIST) 1.1 OR&#xD;
&#xD;
             -  Discontinue treatment&#xD;
&#xD;
      FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:&#xD;
&#xD;
        -  Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented&#xD;
           disease progression per RECIST 1.1&#xD;
&#xD;
      SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:&#xD;
&#xD;
        -  Following completion of an inter-line washout period of a minimum of 2 weeks up to a&#xD;
           maximum of 60 days (or at the discretion of treating investigator) subjects will&#xD;
           receive:&#xD;
&#xD;
             -  Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease&#xD;
                progression per irRECIST 1.1 OR&#xD;
&#xD;
             -  Discontinue treatment&#xD;
&#xD;
      NOTE:&#xD;
&#xD;
      Subjects who do not experience disease progression at end of first-line treatment and are&#xD;
      removed from first-line treatment due to toxicities or personal decision, may also either&#xD;
      receive second-line therapy or be monitored during the inter-line period until progression&#xD;
      (which may be longer than 60 days) per discretion of treating investigator.&#xD;
&#xD;
      Radiological disease evaluation assessments will be completed every 12 weeks.&#xD;
&#xD;
      To demonstrate adequate organ function, all screening labs must be obtained within 14 days&#xD;
      prior to registration:&#xD;
&#xD;
      Hematological:&#xD;
&#xD;
        -  Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3&#xD;
&#xD;
        -  Hemoglobin (Hgb) ≥ 9 g/dL&#xD;
&#xD;
        -  Platelets ≥ 100 K/ mm3&#xD;
&#xD;
      Renal:&#xD;
&#xD;
        -  Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min&#xD;
&#xD;
      Hepatic:&#xD;
&#xD;
        -  Bilirubin ≤ 1.5 × upper limit of normal (ULN)&#xD;
&#xD;
        -  Aspartate aminotransferase (AST) ≤ 2.5 × ULN&#xD;
&#xD;
        -  Alanine aminotransferase (ALT) ≤ 2.5 × ULN&#xD;
&#xD;
      Miscellaneous:&#xD;
&#xD;
        -  Urine/serum pregnancy test - Negative&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Principal investigator left lead institution and efforts to open the protocol at another&#xD;
    institution were not successful.&#xD;
  </why_stopped>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open-Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Progression-Free Survival (PFS)</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Compare PFS1 + PFS2 rates for overall PFS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Failure-Free Survival (FFS)</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Compare FFS1 rates for first-line therapy on each arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Compare OS rates for subjects on each arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (RR)</measure>
    <time_frame>2 years</time_frame>
    <description>Compare RR and PFS1 of sunitinib vs. avelumab as first-line therapy and PFS2 as second-line therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Toxicities</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Describe toxicities of sunitinib and avelumab</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Clear-cell Renal Cell Carcinoma</condition>
  <condition>RCC</condition>
  <condition>Kidney Cancer</condition>
  <condition>Clear-cell Kidney Carcinoma</condition>
  <arm_group>
    <arm_group_label>Avelumab then Sunitinib for Investigational Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First-Line Medication:&#xD;
Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.&#xD;
Subjects will have a mandatory an inter-line washout period (14-60 days) before receiving first dose of second-line medication.&#xD;
Second-Line Medication:&#xD;
Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.&#xD;
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunitinib then Avelumab for Investigational Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First-Line Medication:&#xD;
Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.&#xD;
Subjects will have a mandatory inter-line washout period (14-60 days) before receiving first dose of second-line medication.&#xD;
Second-Line Medication:&#xD;
Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.&#xD;
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avelumab</intervention_name>
    <description>Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle</description>
    <arm_group_label>Avelumab then Sunitinib for Investigational Arm A</arm_group_label>
    <arm_group_label>Sunitinib then Avelumab for Investigational Arm B</arm_group_label>
    <other_name>MSB0010718C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <description>Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle</description>
    <arm_group_label>Avelumab then Sunitinib for Investigational Arm A</arm_group_label>
    <arm_group_label>Sunitinib then Avelumab for Investigational Arm B</arm_group_label>
    <other_name>Sutent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet all of the following applicable inclusion criteria to participate in&#xD;
        this study:&#xD;
&#xD;
          -  Written informed consent and HIPAA authorization for release of personal health&#xD;
             information prior to registration.&#xD;
&#xD;
          -  Age ≥ 18 years at the time of consent.&#xD;
&#xD;
          -  Karnofsky performance status ≥ 60 within 28 days prior to registration.&#xD;
&#xD;
          -  Histological or cytological confirmation of ccRCC (component of clear cell histology&#xD;
             required).&#xD;
&#xD;
          -  Measurable metastatic disease according to RECIST 1.1 criteria within 28 days prior to&#xD;
             registration.&#xD;
&#xD;
          -  Received no prior mTOR or PD1/PD-L1 inhibitors (prior IL-2 is allowed). Prior VEGF&#xD;
             inhibitor is allowed only if &gt;12 months prior to registration, and only if earlier if&#xD;
             administered in the neoadjuvant or adjuvant setting&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum pregnancy test within 14&#xD;
             days prior to registration. NOTE: Females are considered of child bearing potential&#xD;
             unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal&#xD;
             ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least&#xD;
             12 consecutive months&#xD;
&#xD;
          -  Females of childbearing potential and males must be willing to abstain from&#xD;
             heterosexual activity or to use 2 forms of effective methods of contraception from the&#xD;
             time of informed consent until 60 days after treatment discontinuation. The two&#xD;
             contraception methods can be comprised of two barrier methods, or a barrier method&#xD;
             plus a hormonal method.&#xD;
&#xD;
          -  As determined by the enrolling physician or protocol designee, ability of the subject&#xD;
             to understand and comply with study procedures for the entire length of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting any of the criteria below may not participate in the study:&#xD;
&#xD;
          -  Active infection requiring systemic therapy.&#xD;
&#xD;
          -  Known HIV positive (HIV testing is not required for eligibility)&#xD;
&#xD;
          -  Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the&#xD;
             mother is being treated on study).&#xD;
&#xD;
          -  Known additional invasive malignancy that is active and/or progressive requiring&#xD;
             treatment; exceptions include locally curable cancers, or other cancer for which the&#xD;
             subject has been disease-free for at least three years or prostate cancer on&#xD;
             surveillance.&#xD;
&#xD;
          -  Active central nervous system (CNS) metastases (previously treated CNS metastasis are&#xD;
             allowed if subject completed radiation ≥2 weeks earlier and off steroids, and&#xD;
             neurologically stable or subject has been on requiring ≤10 mg of daily prednisone or&#xD;
             prednisone equivalent dose of another corticosteroid for ≥2 weeks) is acceptable)&#xD;
&#xD;
          -  Treatment with any investigational agent (chemotherapy or biologic treatment) within&#xD;
             28 days prior to registration.&#xD;
&#xD;
          -  Subjects who have not recovered from toxicities from prior systemic anti-cancer&#xD;
             treatment or local therapies (a residual toxicity likely to be chronic but controlled&#xD;
             and manageable is allowed, e.g. endocrine syndromes from prior interleukin-2).&#xD;
&#xD;
          -  Subjects who have undergone major surgery &lt; 4 weeks or minor surgery &lt; 2 weeks prior&#xD;
             to registration. Wounds must be completely healed prior to study entry and subjects&#xD;
             must have recovered from all toxicities from surgery. NOTE: placement of a vascular&#xD;
             access device is not considered major or minor surgery in this regard.&#xD;
&#xD;
          -  Prior radiation therapy is allowed as long as irradiated area was not the sole source&#xD;
             of measurable disease and radiotherapy was completed with recovery from toxicity, at&#xD;
             least 2 weeks prior to registration, and subject has recovered from toxicity. If the&#xD;
             irradiated area is the only site of disease, there must be evidence of progressive&#xD;
             disease outside of the radiation field .&#xD;
&#xD;
          -  Uncontrolled adrenal insufficiency&#xD;
&#xD;
          -  Any active known or suspected autoimmune disease&#xD;
&#xD;
          -  Recent or active bleeding diathesis or arterial vascular event (including embolic&#xD;
             arterial event such as cerebrovascular accident (or transient ischemic attacks) within&#xD;
             6 months of registration. NOTE: subjects with deep venous thrombosis or pulmonary&#xD;
             embolism allowed even within 6 months if controlled on anticoagulation (such as&#xD;
             warfarin or heparin provided that their medication dose and INR/PTT are stable)&#xD;
&#xD;
          -  Previous assignment to treatment during this study. Subjects permanently withdrawn&#xD;
             from study participation will not be allowed to re-enter the study&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic pressure &gt; 140 mm Hg or diastolic pressure &gt; 90 mm&#xD;
             Hg on repeated measurement) despite optimal medical management.&#xD;
&#xD;
          -  Active or clinically significant cardiac disease within 6 months including:&#xD;
&#xD;
               -  Symptomatic Congestive heart failure - New York Heart Association (NYHA)&#xD;
&#xD;
                  &gt; Class II&#xD;
&#xD;
               -  Symptomatic Coronary artery disease (controlled clinically on medication allowed)&#xD;
&#xD;
               -  Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or&#xD;
                  digoxin. Controlled atrial fibrillation is allowed.&#xD;
&#xD;
               -  Unstable angina or myocardial infarction.&#xD;
&#xD;
          -  Any hemorrhage or bleeding event ≥ NCI CTCAE v4 Grade 3 within 4 weeks prior to start&#xD;
             of study medication.&#xD;
&#xD;
          -  Subjects with any previously untreated or concurrent cancer that is distinct in&#xD;
             primary site or histology from ccRCC except cervical cancer in-situ, treated localized&#xD;
             basal cell carcinoma, Gleason score 6 prostate cancer or superficial bladder tumor.&#xD;
&#xD;
          -  Known current or chronic hepatitis B or C infection requiring treatment with antiviral&#xD;
             therapy. (NOTE: testing not required)&#xD;
&#xD;
          -  Presence of non-healing wound, non-healing ulcer or bone fracture.&#xD;
&#xD;
          -  Renal failure requiring hemo- or peritoneal dialysis.&#xD;
&#xD;
          -  Persistent proteinuria ≥ Grade 3 NCI-CTCAE v4 (&gt; 3.5 g/24hrs, measured by urine&#xD;
             protein: creatinine ratio on a random urine sample)&#xD;
&#xD;
          -  Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal,&#xD;
             inhaled, topical steroids, or local steroid injection (e.g., intra-articular&#xD;
             injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone&#xD;
             or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT&#xD;
             scan premedication).&quot;&#xD;
&#xD;
          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed&#xD;
             consent.&#xD;
&#xD;
          -  Pleural effusion or ascites that causes respiratory compromise (≥ Grade 2 dyspnea&#xD;
             NCI-CTCAE v4)&#xD;
&#xD;
          -  History of organ allograft (including corneal transplant)&#xD;
&#xD;
          -  Known or suspected allergy or hypersensitivity to any drugs, study drug classes, or&#xD;
             excipients of the formulations given during the course of this trial.&#xD;
&#xD;
          -  Any uncontrolled malabsorption condition&#xD;
&#xD;
          -  Any condition which in the site investigator's opinion, makes the subject unsuitable&#xD;
             for trial participation.&#xD;
&#xD;
          -  Substance abuse, medical, psychological or social conditions that may interfere with&#xD;
             the subject's participation in the study or evaluation of the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guru Sonpavde, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hoosier Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Hematology Oncology Clinic at Medical West</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.hoosiercancer.org</url>
    <description>Hoosier Cancer Research Network Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hoosier Cancer Research Network</investigator_affiliation>
    <investigator_full_name>Guru Sonpavde</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>Avelumab</keyword>
  <keyword>Sunitinib</keyword>
  <keyword>MSB0010718C</keyword>
  <keyword>Sutent</keyword>
  <keyword>IgG1 antibody</keyword>
  <keyword>Anti-PD-L1</keyword>
  <keyword>Tyrosine kinase inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunitinib</mesh_term>
    <mesh_term>Avelumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035630
org study id: HCRN GU15-223
nct id: NCT03035630
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an open label, randomized phase II trial. Eligible subjects will be randomized in a
      1:1 ratio and stratified for known prognostics variables to one of two first-line medication
      treatment arms. Once disease progression has been documented, and following a required
      inter-line washout period, subjects will receive either second-line medication treatment or
      discontinue treatment, per discretion of treating investigator.
OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to
      one of two arms:

      FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:

        -  Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle
           until documented disease progression per Immune-related Response Evaluation Criteria In
           Solid Tumors (irRECIST) 1.1

      SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:

        -  Following completion of an inter-line washout period of a minimum of 2 weeks up to a
           maximum of 60 days (or at the discretion of treating investigator) subjects will
           receive:

             -  Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until
                documented disease progression per Response Evaluation Criteria In Solid Tumors
                (RECIST) 1.1 OR

             -  Discontinue treatment

      FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:

        -  Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented
           disease progression per RECIST 1.1

      SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:

        -  Following completion of an inter-line washout period of a minimum of 2 weeks up to a
           maximum of 60 days (or at the discretion of treating investigator) subjects will
           receive:

             -  Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease
                progression per irRECIST 1.1 OR

             -  Discontinue treatment

      NOTE:

      Subjects who do not experience disease progression at end of first-line treatment and are
      removed from first-line treatment due to toxicities or personal decision, may also either
      receive second-line therapy or be monitored during the inter-line period until progression
      (which may be longer than 60 days) per discretion of treating investigator.

      Radiological disease evaluation assessments will be completed every 12 weeks.

      To demonstrate adequate organ function, all screening labs must be obtained within 14 days
      prior to registration:

      Hematological:

        -  Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3

        -  Hemoglobin (Hgb) ≥ 9 g/dL

        -  Platelets ≥ 100 K/ mm3

      Renal:

        -  Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min

      Hepatic:

        -  Bilirubin ≤ 1.5 × upper limit of normal (ULN)

        -  Aspartate aminotransferase (AST) ≤ 2.5 × ULN

        -  Alanine aminotransferase (ALT) ≤ 2.5 × ULN

      Miscellaneous:

        -  Urine/serum pregnancy test - Negative
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-Label
measure: Overall Progression-Free Survival (PFS)
time frame: up to 24 months
description: Compare PFS1 + PFS2 rates for overall PFS
measure: Overall Failure-Free Survival (FFS)
time frame: up to 24 months
description: Compare FFS1 rates for first-line therapy on each arm
measure: Overall Survival (OS)
time frame: up to 36 months
description: Compare OS rates for subjects on each arm
measure: Overall Response Rate (RR)
time frame: 2 years
description: Compare RR and PFS1 of sunitinib vs. avelumab as first-line therapy and PFS2 as second-line therapy
measure: Overall Toxicities
time frame: up to 36 months
description: Describe toxicities of sunitinib and avelumab
arm group label: Avelumab then Sunitinib for Investigational Arm A
arm group type: Experimental
description: First-Line Medication:
Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.
Subjects will have a mandatory an inter-line washout period (14-60 days) before receiving first dose of second-line medication.
Second-Line Medication:
Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.
arm group label: Sunitinib then Avelumab for Investigational Arm B
arm group type: Experimental
description: First-Line Medication:
Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.
Subjects will have a mandatory inter-line washout period (14-60 days) before receiving first dose of second-line medication.
Second-Line Medication:
Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.
Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.
intervention type: Drug
intervention name: Avelumab
description: Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle
arm group label: Avelumab then Sunitinib for Investigational Arm A
arm group label: Sunitinib then Avelumab for Investigational Arm B
other name: MSB0010718C
intervention type: Drug
intervention name: Sunitinib
description: Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle
arm group label: Avelumab then Sunitinib for Investigational Arm A
arm group label: Sunitinib then Avelumab for Investigational Arm B
other name: Sutent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guru Sonpavde, M.D.
role: Study Chair
affiliation: Hoosier Cancer Research Network
facility: 
country: United States
url: http://www.hoosiercancer.org
description: Hoosier Cancer Research Network Website
responsible party type: Sponsor-Investigator
investigator affiliation: Hoosier Cancer Research Network
investigator full name: Guru Sonpavde
investigator title: Sponsor-Investigator
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Kidney Neoplasms
mesh term: Sunitinib
mesh term: Avelumab
sharing ipd: No