<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/NCT03833427</url>
  </required_header>
  <id_info>
    <org_study_id>5618-001</org_study_id>
    <secondary_id>MK-5618-001</secondary_id>
    <nct_id>NCT03833427</nct_id>
  </id_info>
  <brief_title>Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)</brief_title>
  <official_title>A Phase 1b Multi-center Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</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 study will examine the safety, pharmacokinetics, and efficacy of escalating doses of&#xD;
      selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for&#xD;
      participants with advanced / metastatic solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">June 28, 2022</completion_date>
  <primary_completion_date type="Actual">June 28, 2022</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>Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)</measure>
    <time_frame>Up to Day 21 of Cycle 1 (each cycle is 21 days)</time_frame>
    <description>DLTs are defined as toxicities that: 1) are possibly, probably, or definitely related to study therapy; and 2) meet pre-defined severity criteria. For each arm, the number of participants experiencing DLTs will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing an Adverse Event (AE)</measure>
    <time_frame>Up to 40 months</time_frame>
    <description>An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Discontinuing Study Treatment due to an Adverse Event</measure>
    <time_frame>Up to 27 months</time_frame>
    <description>An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants discontinuing study treatment due to an AE will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve (AUC) of Selumetinib</measure>
    <time_frame>[Cycle 1]: At designated time points; up to 3 weeks (each cycle is 21 days)</time_frame>
    <description>Plasma selumetinib concentration will be quantified for each arm to determine AUC, defined as the area under the concentration-time curve for selumetinib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Selumetinib</measure>
    <time_frame>[Cycle 1]: At designated time points; up to 3 weeks (each cycle is 21 days)</time_frame>
    <description>Plasma selumetinib concentration will be quantified for each arm to determine Cmax, defined as the maximum observed concentration of selumetinib in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Plasma Concentration (Cmin) of Selumetinib</measure>
    <time_frame>[Cycles 1 to 5]: At designated time points; up to 15 weeks (each cycle is 21 days)</time_frame>
    <description>Plasma selumetinib concentration will be quantified for each arm to determine Cmin, defined as the minimum observed concentration of selumetinib in plasma.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Advanced/Metastatic Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 1 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; every three weeks [Q3W]) in combination with selumetinib at dose level 1 (dosed orally; twice daily [BID]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 2 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 2 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 3 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 3 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 4 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 4 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 5 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 5 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 6 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 6 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selumetinib at Dose Level 7 + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 7 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selumetinib</intervention_name>
    <description>Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&amp;2 of each 3-week treatment cycle.</description>
    <arm_group_label>Selumetinib at Dose Level 1 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 2 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 3 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 4 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 5 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 6 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 7 + Pembrolizumab</arm_group_label>
    <other_name>MK-5618</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.</description>
    <arm_group_label>Selumetinib at Dose Level 1 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 2 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 3 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 4 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 5 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 6 + Pembrolizumab</arm_group_label>
    <arm_group_label>Selumetinib at Dose Level 7 + Pembrolizumab</arm_group_label>
    <other_name>KEYTRUDA®</other_name>
    <other_name>MK-3475</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a histologically or cytologically confirmed advanced or metastatic solid tumor by&#xD;
             pathology report and have received, or been intolerant to, all treatment known to&#xD;
             confer clinical benefit.&#xD;
&#xD;
          -  Has measurable disease by Response Evaluation Criteria in Solid Tumors, Version 1.1&#xD;
             (RECIST 1.1) as assessed by local site investigator/radiology. Target lesions situated&#xD;
             in a previously irradiated area are considered measurable if progression has been&#xD;
             demonstrated in such lesions.&#xD;
&#xD;
          -  Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             Performance Scale.&#xD;
&#xD;
          -  Is able to swallow and retain oral medication and has no clinically significant&#xD;
             gastrointestinal abnormalities that might alter absorption.&#xD;
&#xD;
          -  Has adequate organ function.&#xD;
&#xD;
          -  If male, agree to use a contraception during the treatment period and for at least 120&#xD;
             days after the last dose of study intervention and refrain from donating sperm during&#xD;
             this period.&#xD;
&#xD;
          -  If female, is not pregnant or breastfeeding, and is not a woman of childbearing&#xD;
             potential (WOCBP). If a WOCBP, agree to follow the contraceptive guidance during the&#xD;
             treatment period and for at least 120 days after the last dose of study intervention.&#xD;
&#xD;
          -  For Human immunodeficiency virus (HIV) infected participants, must have well&#xD;
             controlled HIV on a stable regimen of anti-retroviral therapy (ART). Participants on&#xD;
             ART must have been without changes in drugs or dose modification for at least 4 weeks&#xD;
             prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had chemotherapy, definitive radiation, or biological cancer therapy within 4&#xD;
             weeks (2 weeks for palliative radiation) prior to the first dose of study treatment,&#xD;
             or has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or&#xD;
             better from any AEs that were due to cancer therapeutics administered more than 4&#xD;
             weeks earlier (this includes participants with previous immunomodulatory therapy with&#xD;
             residual immune-related AEs). Participants receiving ongoing replacement hormone&#xD;
             therapy for endocrine immune-related AEs will not be excluded from participation in&#xD;
             this study.&#xD;
&#xD;
          -  Has clinically active central nervous system metastases and/or carcinomatous&#xD;
             meningitis.&#xD;
&#xD;
          -  Has had a severe hypersensitivity reaction (≥ Grade 3) to treatment with a monoclonal&#xD;
             antibody/component of the study treatment, and/or has a history of allergic reactions&#xD;
             attributed to compounds of similar chemical or biologic composition to agents and/or&#xD;
             excipients used in the study.&#xD;
&#xD;
          -  Has an active infection requiring therapy.&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required steroids or has current&#xD;
             pneumonitis.&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in the past 2&#xD;
             years except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as&#xD;
             thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or&#xD;
             pituitary insufficiency, is not considered a form of systemic treatment and is&#xD;
             allowed. Use of non-systemic steroids is permitted.&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to allocation.&#xD;
&#xD;
          -  Has known Hepatitis B or C infection.&#xD;
&#xD;
          -  For HIV infected participants, has a history of Kaposi's sarcoma and/or Multicentric&#xD;
             Castleman's Disease.&#xD;
&#xD;
          -  Has undergone major surgery and has not recovered adequately from any toxicity and/or&#xD;
             complications from the intervention prior to starting study therapy.&#xD;
&#xD;
          -  Has baseline peripheral neuropathy/paresthesia Grade 1.&#xD;
&#xD;
          -  Has any medical, psychiatric, cognitive, or other condition that may compromise the&#xD;
             participant's ability to understand the participant information, give informed&#xD;
             consent, comply with the study protocol, or complete the study, in the opinion of the&#xD;
             treating investigator.&#xD;
&#xD;
          -  Participants with clinically significant cardiovascular disease as defined by the&#xD;
             following: 1) Uncontrolled hypertension; 2) Left ventricular ejection fraction (LVEF)&#xD;
             &lt;55%; 3) Symptomatic heart failure (New York Heart Association (NYHA) Grade II to IV),&#xD;
             prior or current cardiomyopathy, or severe valvular heart disease; 4) Uncontrolled&#xD;
             angina; 5) Clinically significant cardiac arrhythmia and/or conduction abnormality ≤6&#xD;
             months prior to start of study treatment; 6) Myocardial infarction or acute coronary&#xD;
             syndrome ≤6 months prior to start of study treatment; 7) Mean QT interval calculated&#xD;
             according to the Frederica method (QTcF) interval: Male &gt;450 ms; Female &gt;470 ms.&#xD;
&#xD;
          -  Has a history of thromboembolic or cerebrovascular event(s) within 6 months prior to&#xD;
             study enrollment, including transient ischemic attack, cerebrovascular accident, deep&#xD;
             vein thrombosis, or pulmonary embolism.&#xD;
&#xD;
          -  Has a neuromuscular disorder associated with an elevated creatine kinase (e.g.,&#xD;
             inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal&#xD;
             muscular atrophy.&#xD;
&#xD;
          -  Has a history of, or current, retinal vein occlusion (RVO) or current risk factors for&#xD;
             RVO (e.g., uncontrolled glaucoma, ocular hypertension, history of hyperviscosity, or&#xD;
             hypercoagulability syndromes).&#xD;
&#xD;
          -  Has retinal degenerative disease.&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the study, interfere with the participant's&#xD;
             participation for the full duration of the study, make administration of the study&#xD;
             treatments hazardous or make it difficult to monitor adverse effects such that it is&#xD;
             not in the best interest of the participant to participate, in the opinion of the&#xD;
             treating investigator.&#xD;
&#xD;
          -  Has a known psychiatric or substance abuse disorder that would interfere with the&#xD;
             Participant's ability to cooperate with the requirements of the study.&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the study.&#xD;
&#xD;
          -  Has received a live-virus vaccine within 28 days of planned treatment start. Seasonal&#xD;
             flu vaccines that do not contain live virus are permitted.&#xD;
&#xD;
          -  Is currently participating and receiving study treatment in a study of an&#xD;
             investigational agent or has participated and received study treatment in a study of&#xD;
             an investigational agent or has used an investigational device within 28 days of&#xD;
             administration of selumetinib.&#xD;
&#xD;
          -  Is a WOCBP who has a positive urine pregnancy test within 24 hours before the first&#xD;
             dose of study treatment.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope National Medical Center ( Site 0004)</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START Midwest ( Site 0001)</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center ( Site 0002)</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0003)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0014)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec Universite de Laval ( Site 0013)</name>
      <address>
        <city>Quebec</city>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>programmed cell death 1 (PD-1, PD1)</keyword>
  <keyword>programmed cell death ligand 1 (PD-L1, PDL1)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>June 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03833427
org study id: 5618-001
secondary id: MK-5618-001
nct id: NCT03833427
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will examine the safety, pharmacokinetics, and efficacy of escalating doses of
      selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for
      participants with advanced / metastatic solid tumors.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
time frame: Up to Day 21 of Cycle 1 (each cycle is 21 days)
description: DLTs are defined as toxicities that: 1) are possibly, probably, or definitely related to study therapy; and 2) meet pre-defined severity criteria. For each arm, the number of participants experiencing DLTs will be assessed.
measure: Number of Participants Experiencing an Adverse Event (AE)
time frame: Up to 40 months
description: An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
measure: Number of Participants Discontinuing Study Treatment due to an Adverse Event
time frame: Up to 27 months
description: An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants discontinuing study treatment due to an AE will be assessed.
measure: Area Under the Concentration-Time Curve (AUC) of Selumetinib
time frame: [Cycle 1]: At designated time points; up to 3 weeks (each cycle is 21 days)
description: Plasma selumetinib concentration will be quantified for each arm to determine AUC, defined as the area under the concentration-time curve for selumetinib.
measure: Maximum Observed Plasma Concentration (Cmax) of Selumetinib
time frame: [Cycle 1]: At designated time points; up to 3 weeks (each cycle is 21 days)
description: Plasma selumetinib concentration will be quantified for each arm to determine Cmax, defined as the maximum observed concentration of selumetinib in plasma.
measure: Minimum Observed Plasma Concentration (Cmin) of Selumetinib
time frame: [Cycles 1 to 5]: At designated time points; up to 15 weeks (each cycle is 21 days)
description: Plasma selumetinib concentration will be quantified for each arm to determine Cmin, defined as the minimum observed concentration of selumetinib in plasma.
arm group label: Selumetinib at Dose Level 1 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; every three weeks [Q3W]) in combination with selumetinib at dose level 1 (dosed orally; twice daily [BID]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 2 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 2 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 3 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 3 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 4 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 4 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 5 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 5 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 6 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 6 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
arm group label: Selumetinib at Dose Level 7 + Pembrolizumab
arm group type: Experimental
description: Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 7 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
intervention type: Drug
intervention name: Selumetinib
description: Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
arm group label: Selumetinib at Dose Level 1 + Pembrolizumab
arm group label: Selumetinib at Dose Level 2 + Pembrolizumab
arm group label: Selumetinib at Dose Level 3 + Pembrolizumab
arm group label: Selumetinib at Dose Level 4 + Pembrolizumab
arm group label: Selumetinib at Dose Level 5 + Pembrolizumab
arm group label: Selumetinib at Dose Level 6 + Pembrolizumab
arm group label: Selumetinib at Dose Level 7 + Pembrolizumab
other name: MK-5618
intervention type: Biological
intervention name: Pembrolizumab
description: Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
arm group label: Selumetinib at Dose Level 1 + Pembrolizumab
arm group label: Selumetinib at Dose Level 2 + Pembrolizumab
arm group label: Selumetinib at Dose Level 3 + Pembrolizumab
arm group label: Selumetinib at Dose Level 4 + Pembrolizumab
arm group label: Selumetinib at Dose Level 5 + Pembrolizumab
arm group label: Selumetinib at Dose Level 6 + Pembrolizumab
arm group label: Selumetinib at Dose Level 7 + Pembrolizumab
other name: KEYTRUDA®
other name: MK-3475
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
submitted: June 9, 2023