<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/NCT03821935</url>
  </required_header>
  <id_info>
    <org_study_id>M19-345</org_study_id>
    <secondary_id>2018-004303-40</secondary_id>
    <nct_id>NCT03821935</nct_id>
  </id_info>
  <brief_title>Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151)&#xD;
      administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to&#xD;
      assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of&#xD;
      livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts:&#xD;
      dose escalation and dose expansion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Anticipated">April 11, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 11, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy</measure>
    <time_frame>Up to 28 days after the first dose of Livmoniplimab monotherapy</time_frame>
    <description>The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy</measure>
    <time_frame>Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy</time_frame>
    <description>The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Expansion: Objective Response Rate (ORR)</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant in Dose Expansion</time_frame>
    <description>ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion: Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant in Dose Expansion</time_frame>
    <description>The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion: Progression-free Survival (PFS)</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant in Dose Expansion</time_frame>
    <description>Progression-free survival is defined as the time from the participant's first dose of study treatment (livmoniplimab or budigalimab) to the first date of either disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of Livmoniplimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Maximum Serum Concentration (Cmax) of livmoniplimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Time to maximum serum concentration (Tmax) of livmoniplimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of livmoniplimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal-phase Elimination Rate Constant (β) of Livmoniplimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Apparent terminal phase elimination rate constant (β or Beta) of livmoniplimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Terminal phase elimination half-life (t1/2) of livmoniplimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of Budigalimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Maximum Serum Concentration (Cmax) of budigalimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Time to maximum serum concentration (Tmax) of budigalimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of budigalimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal-phase Elimination Rate Constant (β) of Budigalimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Apparent terminal phase elimination rate constant (β or Beta) of budigalimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Phase Elimination Half-life (t1/2) of Budigalimab</measure>
    <time_frame>Up to approximately 70 days after initial dose of study drug</time_frame>
    <description>Terminal phase elimination half-life (t1/2) of budigalimab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 9 months after the first dose date of last participant</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vital Signs</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant</time_frame>
    <description>Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Parameters</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant</time_frame>
    <description>Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Electrocardiogram (ECG)</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant</time_frame>
    <description>12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Anti-drug Antibody (ADA)</measure>
    <time_frame>Up to approximately 6 months after the first dose date of last participant</time_frame>
    <description>The number of participants with anti-drug antibodies.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Anticipated">337</enrollment>
  <condition>Advanced Solid Tumors Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 1 Livmoniplimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) [unselected] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with non-small cell lung cancer (NSCLC) [programmed death ligand 1 (PDL1) relapsed/refractory (R/R)] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with NSCLC (1L PD-L1 high) Tumor Proportion Score (TPS) &gt;= 50% will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with NSCLC (1L PD-L1 high) TPS &gt;= 50%; will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with microsatellite stable colorectal cancer (MSS-CRC) [consensus molecular subtype 4 (CMS4) enriched] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Livmoniplimab</intervention_name>
    <description>Liquid for intravenous infusion.</description>
    <arm_group_label>Dose Escalation: Cohort 1 Livmoniplimab</arm_group_label>
    <arm_group_label>Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab</arm_group_label>
    <other_name>ABBV-151</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budigalimab</intervention_name>
    <description>Lyophilized powder for solution for intravenous infusion.</description>
    <arm_group_label>Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab</arm_group_label>
    <other_name>ABBV-181</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For Dose Escalation only: Participants with an advanced solid tumor who are considered&#xD;
             refractory to or intolerant of all existing therapy(ies) known to provide a clinical&#xD;
             benefit for their condition. Additionally, participants who have been offered standard&#xD;
             therapies and refused, or who are considered ineligible for standard therapies, may be&#xD;
             eligible for this study on a case-by-case basis, after discussion with and agreement&#xD;
             from the sponsor. Participants with pancreatic adenocarcinoma, urothelial cancer,&#xD;
             hepatocellular carcinoma (HCC), or head and neck squamous cell carcinoma (HNSCC) who&#xD;
             are being considered for the dose escalation cohorts must also meet the histology&#xD;
             specific eligibility criteria described below for dose expansion.&#xD;
&#xD;
          -  For Dose Expansion only participants must meet criteria specific to the type of&#xD;
             cancer:&#xD;
&#xD;
               -  Pancreatic adenocarcinoma and have disease progression during or after 1 systemic&#xD;
                  therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX&#xD;
                  [or another regimen including both 5-fluorouracil and oxaliplatin], capecitabine&#xD;
                  monotherapy or in combination with other agents) administered in the adjuvant,&#xD;
                  locally advanced, or metastatic setting. If the therapy was used in an adjuvant&#xD;
                  setting, disease progression must have occurred within 6 months of completing&#xD;
                  adjuvant therapy.&#xD;
&#xD;
               -  Urothelial cancer of the bladder and urinary tract and must have progressed&#xD;
                  following treatment with a platinum-based regimen (administered in any line of&#xD;
                  therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist&#xD;
                  administered in the recurrent or metastatic setting (progression following a&#xD;
                  PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months&#xD;
                  of the last dose of anti-PD1 or anti-PDL1 therapy).&#xD;
&#xD;
               -  HCC and must have disease progression during or after 1 prior line of systemic&#xD;
                  therapy.&#xD;
&#xD;
               -  HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must&#xD;
                  have progressed following treatment with platinum-based regimen (administered in&#xD;
                  any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or&#xD;
                  metastatic setting (progression following a PD1/PDL1 antagonist is defined as&#xD;
                  unequivocal progression on or within 3 months of the last dose of anti-PD1 or&#xD;
                  anti-PDL1 therapy).&#xD;
&#xD;
               -  Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participants with&#xD;
                  microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as&#xD;
                  determined by polymerase chain reaction (PCR)/Next-Generation sequencing (NGS) or&#xD;
                  immunohistochemistry (IHC), respectively) who have received 1-2 prior&#xD;
                  chemotherapy regimens.&#xD;
&#xD;
               -  Non-small cell lung cancer (NSCLC) relapsed/refractory (R/R): Participants with&#xD;
                  histologically or cytologically confirmed advanced or metastatic NSCLC who have&#xD;
                  received 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody,&#xD;
                  administered either concurrently or sequentially in the metastatic setting.&#xD;
&#xD;
               -  NSCLC (1L PD-L1 high) with liver metastasis enrichment: Participants with&#xD;
                  histologically or cytologically confirmed advanced or metastatic NSCLC, with high&#xD;
                  expression PD-L1 as defined by Tumor Proportion Score (TPS) &gt;=50%, no known&#xD;
                  (EGFR) mutations or ALK gene rearrangements, who have received no prior therapy&#xD;
                  in the advanced or metastatic setting.&#xD;
&#xD;
               -  MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatch&#xD;
                  repair proficient colorectal adenocarcinoma who have received prior&#xD;
                  fluorouracil-based combination chemotherapy regimens including oxaliplatin and&#xD;
                  irinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4&#xD;
                  subtype as determined by NGS of tumor biopsies. Archival tissue must be submitted&#xD;
                  for assessment of CMS4 subtype status during prescreening.&#xD;
&#xD;
          -  Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0&#xD;
             to 1.&#xD;
&#xD;
          -  Participant has adequate bone marrow, renal, hepatic, and coagulation function.&#xD;
&#xD;
          -  Must have a viral status consistent with the requirements described in the protocol&#xD;
             specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For Dose Expansion only:&#xD;
&#xD;
               -  Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having prior&#xD;
                  exposure to a prior PD-1/PD-L1 antagonist in any line of therapy.&#xD;
&#xD;
               -  Participants (except for participants with urothelial cancer or HNSCC) who have&#xD;
                  had prior exposure to immunotherapies as listed in the protocol.&#xD;
&#xD;
          -  Has received anticancer therapy including chemotherapy, immunotherapy, radiation&#xD;
             therapy, biologic, herbal therapy, or any investigational therapy within a period of 5&#xD;
             half-lives or 28 days (whichever is shorter), prior to the first dose of the study&#xD;
             drug.&#xD;
&#xD;
          -  Participant has unresolved AEs &gt; Grade 1 from prior anticancer therapy except for&#xD;
             alopecia.&#xD;
&#xD;
          -  Has a history of primary immunodeficiency, bone marrow transplantation, solid organ&#xD;
             transplantation, or previous clinical diagnosis of tuberculosis.&#xD;
&#xD;
          -  Has a known uncontrolled metastases to the central nervous system (with certain&#xD;
             exceptions).&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 14 days prior to the first&#xD;
             dose of the study drug.&#xD;
&#xD;
          -  Has clinically significant uncontrolled condition(s).&#xD;
&#xD;
          -  History of inflammatory bowel disease, interstitial lung disease or pneumonitis,&#xD;
             myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction&#xD;
             with eosinophilia and systemic symptoms (DRESS).&#xD;
&#xD;
          -  Live vaccine administration &lt;= 28 days prior to the first dose of study drug.&#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>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ABBVIE CALL CENTER</last_name>
    <phone>844-663-3742</phone>
    <email>abbvieclinicaltrials@abbvie.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yale University /ID# 208356</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>AdventHealth Celebration /ID# 224860</name>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747-4970</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AdventHealth Cancer Institute - Orlando /ID# 226953</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Indiana Univ School Medicine /ID# 208384</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Univ Michigan Med Ctr /ID# 221129</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center /ID# 209822</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016-6402</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carolina BioOncology Institute /ID# 208358</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University - The James /ID# 217611</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210-1240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>NEXT Oncology /ID# 208930</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse /ID# 213236</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Icon Cancer Centre /ID# 224961</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 218466</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre /ID# 209423</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hopital Purpan /ID# 218667</name>
      <address>
        <city>TOULOUSE Cedex 9</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard /ID# 218515</name>
      <address>
        <city>Lyon CEDEX 08</city>
        <state>Rhone</state>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy /ID# 218668</name>
      <address>
        <city>Villejuif Cedex</city>
        <state>Val-de-Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin /ID# 218669</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 209037</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 222199</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 222198</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East /ID# 224808</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital /ID# 209421</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System Severance Hospital /ID# 218512</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 218513</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pan American Center for Oncology Trials, LLC /ID# 217475</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona /ID# 221106</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz /ID# 220928</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia /ID# 221107</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 218492</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital /ID# 218490</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=M19-345</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced Solid Tumors Cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>metastatic</keyword>
  <keyword>monotherapy</keyword>
  <keyword>combination therapy</keyword>
  <keyword>triple negative breast cancer (TNBC)</keyword>
  <keyword>pancreatic adenocarcinoma</keyword>
  <keyword>urothelial cancer</keyword>
  <keyword>hepatocellular carcinoma (HCC)</keyword>
  <keyword>head and neck squamous cell carcinoma (HNSCC)</keyword>
  <keyword>Colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT03821935
org study id: M19-345
secondary id: 2018-004303-40
nct id: NCT03821935
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151)
      administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to
      assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of
      livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts:
      dose escalation and dose expansion.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy
time frame: Up to 28 days after the first dose of Livmoniplimab monotherapy
description: The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.
measure: Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy
time frame: Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy
description: The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
measure: Dose Expansion: Objective Response Rate (ORR)
time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
description: ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
measure: Dose Expansion: Duration of Response (DOR)
time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
description: The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
measure: Dose Expansion: Progression-free Survival (PFS)
time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
description: Progression-free survival is defined as the time from the participant's first dose of study treatment (livmoniplimab or budigalimab) to the first date of either disease progression or death, whichever occurs first.
measure: Maximum Observed Serum Concentration (Cmax) of Livmoniplimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Maximum Serum Concentration (Cmax) of livmoniplimab.
measure: Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Time to maximum serum concentration (Tmax) of livmoniplimab.
measure: Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of livmoniplimab.
measure: Terminal-phase Elimination Rate Constant (β) of Livmoniplimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Apparent terminal phase elimination rate constant (β or Beta) of livmoniplimab.
measure: Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Terminal phase elimination half-life (t1/2) of livmoniplimab.
measure: Maximum Observed Serum Concentration (Cmax) of Budigalimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Maximum Serum Concentration (Cmax) of budigalimab.
measure: Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Time to maximum serum concentration (Tmax) of budigalimab.
measure: Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of budigalimab.
measure: Terminal-phase Elimination Rate Constant (β) of Budigalimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Apparent terminal phase elimination rate constant (β or Beta) of budigalimab.
measure: Terminal Phase Elimination Half-life (t1/2) of Budigalimab
time frame: Up to approximately 70 days after initial dose of study drug
description: Terminal phase elimination half-life (t1/2) of budigalimab.
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to approximately 9 months after the first dose date of last participant
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
measure: Change in Vital Signs
time frame: Up to approximately 6 months after the first dose date of last participant
description: Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
measure: Change in Laboratory Parameters
time frame: Up to approximately 6 months after the first dose date of last participant
description: Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
measure: Change in Electrocardiogram (ECG)
time frame: Up to approximately 6 months after the first dose date of last participant
description: 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
measure: Incidence of Anti-drug Antibody (ADA)
time frame: Up to approximately 6 months after the first dose date of last participant
description: The number of participants with anti-drug antibodies.
arm group label: Dose Escalation: Cohort 1 Livmoniplimab
arm group type: Experimental
description: Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
arm group label: Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
arm group label: Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) [unselected] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with non-small cell lung cancer (NSCLC) [programmed death ligand 1 (PDL1) relapsed/refractory (R/R)] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
arm group label: Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with NSCLC (1L PD-L1 high) Tumor Proportion Score (TPS) >= 50% will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.
arm group label: Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with NSCLC (1L PD-L1 high) TPS >= 50%; will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.
arm group label: Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with microsatellite stable colorectal cancer (MSS-CRC) [consensus molecular subtype 4 (CMS4) enriched] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.
arm group label: Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab
arm group type: Experimental
description: Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.
intervention type: Drug
intervention name: Livmoniplimab
description: Liquid for intravenous infusion.
arm group label: Dose Escalation: Cohort 1 Livmoniplimab
arm group label: Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab
other name: ABBV-151
intervention type: Drug
intervention name: Budigalimab
description: Lyophilized powder for solution for intravenous infusion.
arm group label: Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 9A Livmoniplimab + Budigalimab
arm group label: Dose Expansion: Cohort 9B Livmoniplimab + Budigalimab
other name: ABBV-181
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: ABBVIE CALL CENTER
phone: 844-663-3742
email: abbvieclinicaltrials@abbvie.com
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Belgium
country: Canada
country: France
country: Israel
country: Japan
country: Korea, Republic of
country: Puerto Rico
country: Spain
country: Taiwan
country: United States
url: https://www.abbvieclinicaltrials.com/study/?id=M19-345
description: Related Info
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No