<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/NCT04417621</url>
  </required_header>
  <id_info>
    <org_study_id>CLXH254C12201</org_study_id>
    <secondary_id>2020-000873-26</secondary_id>
    <nct_id>NCT04417621</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma</brief_title>
  <official_title>A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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>
      The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in&#xD;
      previously treated unresectable or metastatic melanoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Anticipated">January 26, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>35 months</time_frame>
    <description>Confirmed ORR using RECIST v1.1, per local assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Reposnse (DOR)</measure>
    <time_frame>4 years</time_frame>
    <description>Local and central assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>3 years</time_frame>
    <description>Using RECIST v1.1, per local and central assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (Cmax) for LXH254 &amp; LTT462</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (Cmax) for LXH254 &amp; trametinib</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (Cmax) for LXH254 &amp; ribociclib</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (AUC) for LXH254 &amp; LTT462</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (AUC) for LXH254 &amp; trametinib</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derived PK parameter (AUC) for LXH254 &amp; ribociclib</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>35 months</time_frame>
    <description>Number of participants with Adverse Events (AEs) and SAEs as a measure of safety and tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Interruptions</measure>
    <time_frame>35 months</time_frame>
    <description>Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose reductions</measure>
    <time_frame>35 months</time_frame>
    <description>Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>LXH254 + LTT462</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LXH254 + trametinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LXH254 + ribociclib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LXH254</intervention_name>
    <description>LXH254 will be supplied as tablet for oral use.</description>
    <arm_group_label>LXH254 + LTT462</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LTT462</intervention_name>
    <description>LTT462 will be supplied as hard gelatin capsule for oral use.</description>
    <arm_group_label>LXH254 + LTT462</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trametinib</intervention_name>
    <description>Trametinib will be supplied as film-coated tablet for oral use</description>
    <arm_group_label>LXH254 + trametinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribociclib</intervention_name>
    <description>Ribociclib will be supplied in tablets and hard gelatin capsules.</description>
    <arm_group_label>LXH254 + ribociclib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight &gt; 40kg&#xD;
        Histologically confirmed unresectable or metastatic cutaneous melanoma&#xD;
&#xD;
        Previously treated for unresectable or metastatic melanoma:&#xD;
&#xD;
          -  Participants with NRAS mutation:&#xD;
&#xD;
          -  Participants must have received prior systemic therapy for unresectable or metastatic&#xD;
             melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent&#xD;
             or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally&#xD;
             directed anti-neoplastic agents.&#xD;
&#xD;
          -  A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable&#xD;
             or metastatic melanoma are allowed. Additional agents administered with CPI are&#xD;
             permitted.&#xD;
&#xD;
          -  To rule out pseudo-progression, participants must have documented confirmed&#xD;
             progressive disease as per RECIST v1.1 while on/after treatment with checkpoint&#xD;
             inhibitor therapy. Confirmation is not required for patients who remained on treatment&#xD;
             for &gt;6 months.&#xD;
&#xD;
          -  Participants with BRAFV600 mutant disease:&#xD;
&#xD;
          -  Participants must have received prior systemic therapy for unresectable or metastatic&#xD;
             melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent&#xD;
             or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally&#xD;
             directed anti-neoplastic agents. Additionally, participants must have received&#xD;
             targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI&#xD;
             allowed) as the last prior therapy.&#xD;
&#xD;
          -  A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable&#xD;
             or metastatic melanoma are allowed. Additional agents with CPI are permitted.&#xD;
&#xD;
          -  A maximum of one line of targeted therapy is allowed, and it must be the most recent&#xD;
             line of therapy.&#xD;
&#xD;
          -  Participants must have documented progressive disease as per RECIST v1.1 while&#xD;
             on/after treatment with targeted therapy.&#xD;
&#xD;
        Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Treatment with any of the following anti-cancer therapies prior to the first dose of study&#xD;
        treatment within the stated timeframes:&#xD;
&#xD;
          -  ≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for&#xD;
             palliation prior to the first dose of study treatment.&#xD;
&#xD;
          -  ≤ 2 weeks for small molecule therapeutics.&#xD;
&#xD;
          -  ≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.&#xD;
&#xD;
          -  ≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other&#xD;
             investigational agents.&#xD;
&#xD;
          -  ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and&#xD;
             mitomycin c.&#xD;
&#xD;
        Participants participating in additional parallel investigational drug or medical device&#xD;
        studies.&#xD;
&#xD;
        All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are&#xD;
        neurologically unstable History or current evidence of retinal vein occlusion (RVO) or&#xD;
        current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of&#xD;
        hyperviscosity or hypercoagulability syndromes).&#xD;
&#xD;
        Any medical condition that would, in the investigator's judgment, prevent the patient's&#xD;
        participation in the clinical study due to safety concerns or compliance with clinical&#xD;
        study procedures.&#xD;
&#xD;
        Other protocol-defined exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Angeles Clinic and Research Institute .</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center .</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists Sarasota Office</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Lee Moffitt Cancer Center and Research Institute Moffitt McKinley Outpatient Ct</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute Dept.of DFCI</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Mayo Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Laura and Isaac Perlmutter Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Dept. of MSKCC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of TX MD Anderson Cancer Center .</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>North Sydney</city>
        <state>New South Wales</state>
        <zip>2060</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wooloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Subiaco</city>
        <state>Western Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marseille Cedex 05</city>
        <zip>13885</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris 10</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M20 2BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LXH254</keyword>
  <keyword>Melanoma</keyword>
  <keyword>NRAS</keyword>
  <keyword>BRAF</keyword>
  <keyword>LTT462</keyword>
  <keyword>Trametinib</keyword>
  <keyword>Ribocliclib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trametinib</mesh_term>
    <mesh_term>Naporafenib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.</ipd_description>
  </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/NCT04417621
org study id: CLXH254C12201
secondary id: 2020-000873-26
nct id: NCT04417621
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in
      previously treated unresectable or metastatic melanoma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: 35 months
description: Confirmed ORR using RECIST v1.1, per local assessment
measure: Duration of Reposnse (DOR)
time frame: 4 years
description: Local and central assessment
measure: Progression Free Survival (PFS)
time frame: 4 years
measure: Disease Control Rate (DCR)
time frame: 3 years
description: Using RECIST v1.1, per local and central assessment
measure: Overall Survival (OS)
time frame: 4 years
measure: Derived PK parameter (Cmax) for LXH254 & LTT462
time frame: Up to 5 months
measure: Derived PK parameter (Cmax) for LXH254 & trametinib
time frame: Up to 5 months
measure: Derived PK parameter (Cmax) for LXH254 & ribociclib
time frame: Up to 5 months
measure: Derived PK parameter (AUC) for LXH254 & LTT462
time frame: Up to 5 months
measure: Derived PK parameter (AUC) for LXH254 & trametinib
time frame: Up to 5 months
measure: Derived PK parameter (AUC) for LXH254 & ribociclib
time frame: Up to 5 months
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
time frame: 35 months
description: Number of participants with Adverse Events (AEs) and SAEs as a measure of safety and tolerability
measure: Dose Interruptions
time frame: 35 months
description: Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions
measure: Dose reductions
time frame: 35 months
description: Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions
arm group label: LXH254 + LTT462
arm group type: Experimental
arm group label: LXH254 + trametinib
arm group type: Experimental
arm group label: LXH254 + ribociclib
arm group type: Experimental
intervention type: Drug
intervention name: LXH254
description: LXH254 will be supplied as tablet for oral use.
arm group label: LXH254 + LTT462
intervention type: Drug
intervention name: LTT462
description: LTT462 will be supplied as hard gelatin capsule for oral use.
arm group label: LXH254 + LTT462
intervention type: Drug
intervention name: Trametinib
description: Trametinib will be supplied as film-coated tablet for oral use
arm group label: LXH254 + trametinib
intervention type: Drug
intervention name: Ribociclib
description: Ribociclib will be supplied in tablets and hard gelatin capsules.
arm group label: LXH254 + ribociclib
criteria: 
gender: All
minimum age: 12 Years
maximum age: 120 Years
healthy volunteers: No
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country: Argentina
country: Australia
country: Belgium
country: France
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Norway
country: Switzerland
country: United Kingdom
country: United States
country: Austria
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Trametinib
mesh term: Naporafenib
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.