<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/NCT03238638</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-1631</org_study_id>
    <nct_id>NCT03238638</nct_id>
  </id_info>
  <brief_title>A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy</brief_title>
  <official_title>A Phase II Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study to test the combination of two drugs, pembrolizumab and epacadostat&#xD;
      with the goal of benefiting subjects with head and neck cancers where prior or ongoing&#xD;
      regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer&#xD;
      after platinum failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective(s) &amp; Hypothesis&#xD;
&#xD;
      (1) Objective: Response Rate&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
      Cohort 1: In patient with prior response to anti-PD-1/PD-L1+ therapy and subsequent&#xD;
      (acquired) resistance combined IDO1 and PD-1 inhibition will re-induce responses.&#xD;
&#xD;
      Cohort 2: In patients with suboptimal benefit from prior anti-PD-1/PD-L1 therapy combined&#xD;
      IDO1 and PD-1 inhibition will induce clinically meaningful responses.&#xD;
&#xD;
      Secondary Objective(s) &amp; Hypothesis&#xD;
&#xD;
        1. Objective: 1-year Progression-free (PFS) and Overall (OS) survival Hypothesis: Combined&#xD;
           PD-1 blockade with pembrolizumab + epacadostat in HNSCC patients will lead to improved&#xD;
           1-year survival in patients who a) progress on prior anti-PD-1/PD/L1 therapy on, and/or&#xD;
           b) compared to patients who progress on 2nd line chemotherapy.&#xD;
&#xD;
        2. Safety Hypothesis: Combined treatment with pembrolizumab and epacadostat will be safe&#xD;
           and tolerable in HNSCC patients.&#xD;
&#xD;
      Exploratory/Translational Objectives&#xD;
&#xD;
        1. Interferon-gamma Gene Expression Profile (GEP) (Seiwert ASCO 2015, Ribas ASCO 2015) and&#xD;
           evaluation of RR, PFS, and OS in GEP positive and GEP negative patients.&#xD;
&#xD;
        2. Determine the micro-environment that underlies resistance/suboptimal treatment&#xD;
&#xD;
             1. underlying degree of tumor inflammation&#xD;
&#xD;
             2. Baseline PD-L1 expression&#xD;
&#xD;
           d) Determine underlying Interferon Gamma signature&#xD;
&#xD;
        3. Assess underlying mutational burden (Snyder 2014)) Preclinical hypothesis: IDO1&#xD;
           inhibition will alter the micro-environment to a be &quot;more T-cell inflamed&quot; and make&#xD;
           tumors amenable to benefit from anti-PD-1 treatment (when given concurrently with IDO1&#xD;
           inhibition). Hence we will evaluate tumors, with prior response exhibiting acquired&#xD;
           resistance as well as tumors with minor/suboptimal benefit from prior PD-1/PD-L1 therapy&#xD;
           for evidence (at baseline) of suboptimal immune microenvironmental conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI did not attempt to open the study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient response rate</measure>
    <time_frame>From the start of treatment to the time of response until disease progression, death, or end of trial, whichever comes first, not to exceed 5 years.</time_frame>
    <description>The number of patients with responses per RECIST 1.1 will be compared to the total number of patients in each cohort (which is anticipated to enroll 15).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>From the time of enrollment until death, withdrawal of consent, or the end of the study, whichever occurs first OR at most 2 years out from the last patient receiving treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year progression free rate</measure>
    <time_frame>From the time of enrollment until the first documented disease progression, death, withdrawal of consent, or the end of the study, whichever occurs first OR at most 2 years out from the last patient receiving treatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>From the start of treatment until the end of study, not to exceed 5 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Acquired Resistance Cohort and Suboptimal Benefit Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be divided into two cohorts. Investigators anticipate 15 patients per cohort.&#xD;
Cohort 1: Acquired Resistance Cohort&#xD;
Treat upon emergence of acquire resistance&#xD;
Prior benefit from an9-PD-1/PD-L1 therapy defined as a. preior response, and/or b. greater than or equal to 5 months of stable disease&#xD;
Progressive disease on recent scans&#xD;
Intercurrent therapy is allowed&#xD;
Cohort 2: Suboptimal Benefit Cohort&#xD;
Treat subop. mal response/benefit, BEFORE emergence of acquired resistance&#xD;
Prolonged stable disease greater than or equal to 5 months OR Subop9mal response (greater than 10% and less than 50%)&#xD;
Ongoing stable disease on recent scans&#xD;
Both cohorts will receive pembrolizumab and epacadostat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Both cohorts will receive pembrolizumab at a flat dose of 200mg every 3 weeks.</description>
    <arm_group_label>Acquired Resistance Cohort and Suboptimal Benefit Cohort</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>epacadostat</intervention_name>
    <description>Both cohorts will receive epacadostat. Patients in cohort 1 will take 300mg of epacadostat by mouth twice per day. Cohort 2 will take 300mg of epacadostat every 6 weeks.</description>
    <arm_group_label>Acquired Resistance Cohort and Suboptimal Benefit Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Patients must have histologically confirmed squamous cell carcinoma of the head and&#xD;
             neck (unresectable and not amenable to curative intent therapy)&#xD;
&#xD;
          -  2. Meet criteria for either the Acquired Resistance OR the Suboptimal Benefit Cohort&#xD;
&#xD;
             a. Acquired Resistance is defined as (i and ii must both be met): i. Prior benefit&#xD;
             from anti-PD-1/PD-L1 therapy defined as a) prior response, and/or b) ≥5 months of&#xD;
             stable disease (SD). Intervening therapies are allowed.&#xD;
&#xD;
        ii. Progressive Disease (PD) on recent scans b. Suboptimal Benefit is defined as (i and ii&#xD;
        must both be met): i. Prolonged stable disease ≥5 months OR Suboptimal response (&gt;10% &amp;&#xD;
        &lt;50% shrinkage per RECIST at any evaluation timepoint) ii. Ongoing stable disease on recent&#xD;
        scans iii. Last treatment with an anti-PD-1/PD-L1 agent within 6 weeks prior to starting&#xD;
        protocol treatment&#xD;
&#xD;
          -  3. Archival tissue for PD-L1 staining (alternatively a new biopsy (core) at baseline&#xD;
             can be used). A minimum of 10 slides is required (unless approval from the PI is&#xD;
             obtained)&#xD;
&#xD;
          -  4. Measurable disease per RECIST 1.1.&#xD;
&#xD;
          -  5. Known HPV status&#xD;
&#xD;
          -  6. ECOG performance status 0 or 1&#xD;
&#xD;
          -  7. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
          -  8. Be greater than or equal to 18 years of age on day of signing informed consent.&#xD;
&#xD;
          -  9. Demonstrate reasonable organ function as defined below, all screening labs should&#xD;
             be performed within 10 days of treatment initiation.&#xD;
&#xD;
        System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets&#xD;
        ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency&#xD;
        (within 7 days of assessment) Renal Serum creatinine OR Measured or calculateda creatinine&#xD;
        clearance ≤1.5 X upper limit of normal (ULN) OR (GFR can also be used in place of&#xD;
        creatinine or CrCl) ≥40 mL/min for subject with creatinine levels &gt; 2.0 X institutional ULN&#xD;
        Hepatic Serum total bilirubin ≤ 1.2 X ULN OR in case of Gilbert's disease an elevated total&#xD;
        Bilirubin is allowed if direct Bilirubin is ≤40% of total AST (SGOT) and ALT (SGPT) ≤ 2.5 X&#xD;
        ULN&#xD;
&#xD;
        Coagulation International Normalized Ratio (INR) or Prothrombin Time ≤1.5 X ULN unless&#xD;
        subject is receiving (PT) anticoagulant therapy as long as PT or PTT is within therapeutic&#xD;
        range of intended use of anticoagulants&#xD;
&#xD;
        Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving&#xD;
        anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of&#xD;
        anticoagulants&#xD;
&#xD;
        *Creatinine clearance should be calculated per institutional standard.&#xD;
&#xD;
          -  10. Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy test within 72 hours prior to receiving the first dose of study medication.&#xD;
             If the urine test is positive or cannot be confirmed as negative, a serum pregnancy&#xD;
             test will be required.&#xD;
&#xD;
          -  11. Female subjects of childbearing potential should be willing to use 2 methods of&#xD;
             birth control or be surgically sterile, or abstain from heterosexual activity for the&#xD;
             course of the study through 120 days after the last dose of study medication&#xD;
             (Reference Section 5.7.2). Subjects of childbearing potential are those who have not&#xD;
             been surgically sterilized or have not been free from menses for &gt; 1 year.&#xD;
&#xD;
          -  12. Male subjects should agree to use an adequate method of contraception starting&#xD;
             with the first dose of study therapy through 120 days after the last dose of study&#xD;
             therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Is currently participating and receiving study therapy or has participated in a&#xD;
             study of an investigational agent and received study therapy or used an&#xD;
             investigational device within 2 weeks of the first dose of treatment.&#xD;
&#xD;
          -  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment.&#xD;
&#xD;
          -  3. Has a known history of active TB (Bacillus Tuberculosis)&#xD;
&#xD;
          -  4. Has hypersensitivity to pembrolizumab, epacadostat or any of its excipients.&#xD;
&#xD;
          -  5. Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study&#xD;
             Day 1, or targeted small molecule therapy within 2 weeks prior to study Day 1, or who&#xD;
             has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents&#xD;
             administered more than 4 weeks earlier.&#xD;
&#xD;
          -  6. Has not recovered from prior surgery, chemotherapy or radiation therapy from&#xD;
             adverse events due to a previous treatment/ administered agent (i.e., ≤ Grade 1 or&#xD;
             return to baseline prior to treatment).&#xD;
&#xD;
        Note: Subjects with ≤ Grade 2 neuropathy, any grade hearing loss or tinnitus, or typical&#xD;
        side effects from radiotherapy are an exception to this criterion and may qualify for the&#xD;
        study.&#xD;
&#xD;
        Note: If subject received major surgery, they must have recovered adequately from the&#xD;
        toxicity and/or complications from the intervention prior to starting therapy.&#xD;
&#xD;
          -  7. Has a known additional malignancy that is progressing or requires active treatment.&#xD;
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
             skin that has undergone potentially curative therapy or in situ cervical cancer or any&#xD;
             tumors that are not likely to influence live expectancy in the subsequent 3 years&#xD;
             without active treatment (e.g. low grade prostate cancer in absence of therapy).&#xD;
&#xD;
          -  8. Has known active (=growing) central nervous system (CNS) metastases and/or&#xD;
             carcinomatous meningitis. Radiation or resected brain metastasis are acceptable if&#xD;
             clinically stable.&#xD;
&#xD;
          -  9. Has active autoimmune disease that has required systemic treatment in the past 2&#xD;
             years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment.&#xD;
&#xD;
          -  10. Has known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
          -  11. Warfarin use, even if low dose warfarin is not acceptable. However, other&#xD;
             anti-coargulants (e.g. aspirin, enoxaparin and heparin derivatives, thrombin&#xD;
             inhibitors, etc) are acceptable.&#xD;
&#xD;
          -  12. Has a history or current evidence of any condition, therapy, or laboratory&#xD;
             abnormality that might confound the results of the trial, interfere with the subject's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator.&#xD;
&#xD;
          -  13. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
          -  14. Is pregnant or breastfeeding, or expecting to conceive or father children within&#xD;
             the projected duration of the trial, starting with the pre-screening or screening&#xD;
             visit through 120 days after the last dose of trial treatment.&#xD;
&#xD;
          -  15. Has received prior therapy with an IDO inhibiting agent.&#xD;
&#xD;
          -  16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
          -  17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA&#xD;
             [qualitative] is detected).&#xD;
&#xD;
          -  18. Has received a live vaccine within 30 days of planned start of study therapy.&#xD;
&#xD;
          -  19. Subjects receiving MAO-inhibitors (MAOI) or drug which has significant MAOI&#xD;
             activity (meperidine, linezolid, methylene blue) within the 21 days before screening.&#xD;
&#xD;
          -  20. Any history of Serotonin Syndrome after receiving serotonergic drugs.&#xD;
&#xD;
          -  21. History or presence of an abnormal electrocardiogram (ECG) that, in the&#xD;
             investigator's opinion, is clinically meaningful. Screening QTc interval &gt; 470&#xD;
             milliseconds is excluded. In the event that a single QTc is &gt; 470 milliseconds, the&#xD;
             subject may enroll if the average QTc for the 3 ECGs is &lt; 470 milliseconds. For&#xD;
             subjects with an intraventricular conduction delay (QRS interval &gt; 120 milliseconds),&#xD;
             the JTc interval may be used in place of the QTc with sponsor approval. The JTc must&#xD;
             be &lt; 340 milliseconds if JTc is used in place of the QTc. Subjects with left bundle&#xD;
             branch block are excluded.&#xD;
&#xD;
        Note: QTc prolongation due to pacemaker may enroll if the JTc is normal.&#xD;
&#xD;
          -  22. Use of any UGT1A9 inhibitor from screening through follow-up period, including the&#xD;
             following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid.&#xD;
&#xD;
          -  23. History of organ transplant that requires use of immunosuppressives.&#xD;
&#xD;
          -  24. Any condition that would jeopardize the safety of the subject or compliance with&#xD;
             the Protocol.&#xD;
&#xD;
          -  25. Clinically significant cardiac disease, including unstable angina, acute&#xD;
             myocardial infarction within 6 months from Day 1 of study drug administration, New&#xD;
             York Heart Association Class III or IV congestive heart failure, and arrhythmia&#xD;
             requiring therapy Note: Seasonal influenza vaccines for injection are generally&#xD;
             inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g.,&#xD;
             Flu-Mist®) are live attenuated vaccines, and are not allowed within 30 days prior to&#xD;
             initiation of 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>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epacadostat</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>PD-1</keyword>
  <keyword>PD-L1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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>
  <!-- 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/NCT03238638
org study id: IRB15-1631
nct id: NCT03238638
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a research study to test the combination of two drugs, pembrolizumab and epacadostat
      with the goal of benefiting subjects with head and neck cancers where prior or ongoing
      regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer
      after platinum failure.
Primary Objective(s) & Hypothesis

      (1) Objective: Response Rate

      Hypotheses:

      Cohort 1: In patient with prior response to anti-PD-1/PD-L1+ therapy and subsequent
      (acquired) resistance combined IDO1 and PD-1 inhibition will re-induce responses.

      Cohort 2: In patients with suboptimal benefit from prior anti-PD-1/PD-L1 therapy combined
      IDO1 and PD-1 inhibition will induce clinically meaningful responses.

      Secondary Objective(s) & Hypothesis

        1. Objective: 1-year Progression-free (PFS) and Overall (OS) survival Hypothesis: Combined
           PD-1 blockade with pembrolizumab + epacadostat in HNSCC patients will lead to improved
           1-year survival in patients who a) progress on prior anti-PD-1/PD/L1 therapy on, and/or
           b) compared to patients who progress on 2nd line chemotherapy.

        2. Safety Hypothesis: Combined treatment with pembrolizumab and epacadostat will be safe
           and tolerable in HNSCC patients.

      Exploratory/Translational Objectives

        1. Interferon-gamma Gene Expression Profile (GEP) (Seiwert ASCO 2015, Ribas ASCO 2015) and
           evaluation of RR, PFS, and OS in GEP positive and GEP negative patients.

        2. Determine the micro-environment that underlies resistance/suboptimal treatment

             1. underlying degree of tumor inflammation

             2. Baseline PD-L1 expression

           d) Determine underlying Interferon Gamma signature

        3. Assess underlying mutational burden (Snyder 2014)) Preclinical hypothesis: IDO1
           inhibition will alter the micro-environment to a be "more T-cell inflamed" and make
           tumors amenable to benefit from anti-PD-1 treatment (when given concurrently with IDO1
           inhibition). Hence we will evaluate tumors, with prior response exhibiting acquired
           resistance as well as tumors with minor/suboptimal benefit from prior PD-1/PD-L1 therapy
           for evidence (at baseline) of suboptimal immune microenvironmental conditions.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient response rate
time frame: From the start of treatment to the time of response until disease progression, death, or end of trial, whichever comes first, not to exceed 5 years.
description: The number of patients with responses per RECIST 1.1 will be compared to the total number of patients in each cohort (which is anticipated to enroll 15).
measure: Overall survival rate
time frame: From the time of enrollment until death, withdrawal of consent, or the end of the study, whichever occurs first OR at most 2 years out from the last patient receiving treatment.
measure: One year progression free rate
time frame: From the time of enrollment until the first documented disease progression, death, withdrawal of consent, or the end of the study, whichever occurs first OR at most 2 years out from the last patient receiving treatment.
measure: Number of patients with adverse events
time frame: From the start of treatment until the end of study, not to exceed 5 years.
arm group label: Acquired Resistance Cohort and Suboptimal Benefit Cohort
arm group type: Experimental
description: Patients will be divided into two cohorts. Investigators anticipate 15 patients per cohort.
Cohort 1: Acquired Resistance Cohort
Treat upon emergence of acquire resistance
Prior benefit from an9-PD-1/PD-L1 therapy defined as a. preior response, and/or b. greater than or equal to 5 months of stable disease
Progressive disease on recent scans
Intercurrent therapy is allowed
Cohort 2: Suboptimal Benefit Cohort
Treat subop. mal response/benefit, BEFORE emergence of acquired resistance
Prolonged stable disease greater than or equal to 5 months OR Subop9mal response (greater than 10% and less than 50%)
Ongoing stable disease on recent scans
Both cohorts will receive pembrolizumab and epacadostat.
intervention type: Drug
intervention name: Pembrolizumab
description: Both cohorts will receive pembrolizumab at a flat dose of 200mg every 3 weeks.
arm group label: Acquired Resistance Cohort and Suboptimal Benefit Cohort
other name: Keytruda
intervention type: Drug
intervention name: epacadostat
description: Both cohorts will receive epacadostat. Patients in cohort 1 will take 300mg of epacadostat by mouth twice per day. Cohort 2 will take 300mg of epacadostat every 6 weeks.
arm group label: Acquired Resistance Cohort and Suboptimal Benefit Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Pembrolizumab