<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/NCT03769532</url>
  </required_header>
  <id_info>
    <org_study_id>TUD-PEMAZA-068</org_study_id>
    <nct_id>NCT03769532</nct_id>
  </id_info>
  <brief_title>MRD-guided Treatment in NPM1mut AML Patients</brief_title>
  <acronym>PEMAZA</acronym>
  <official_title>MRD-guided Treatment With Pembrolizumab and Azacitidine in NPM1mut AML Patients With an Imminent Hematological Relapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation the safety and efficacy of Pembrolizumab (PEM) when administered in combination&#xD;
      with standard Azacitidine (AZA) in nucleophosmin (NPM1) mutated AML patients with molecular&#xD;
      relapse defined by the presence of measurable residual disease (MRD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Azacitidine is an effective and well established therapy in patients with acute myeloid&#xD;
      leukemia (AML). In fact, in previous measurable residual disease (MRD) triggered studies,&#xD;
      azacitidine allowed for a delay towards an overt hematological relapse in the majority of&#xD;
      patients. However, the majority of patients ultimately relapsed even though they received&#xD;
      multiple cycles of preemptive therapy. Hypomethylating agents (HMA) can enhance antitumor&#xD;
      immune responses by upregulating tumor antigene expression, class 1 major histocompatibility&#xD;
      complex, and co-stimulatory molecules, while concurrently dampening this antitumor effect by&#xD;
      upregulating expression of checkpoint receptors or ligands, including programmed cell death&#xD;
      protein 1 (PD-1), programmed cell death ligand 1 (PD-L1), and cytotoxic&#xD;
      T-lymphocyte-associated protein 4 (CTLA-4). Upregulation of these immune checkpoint molecules&#xD;
      might be a mechanism of resistance to hypomethylating drugs. It has been shown that PD-L1&#xD;
      Messenger ribonucleic acid (mRNA) is up-regulated acute myeloid leukemia cluster of&#xD;
      differentiation 34 (CD34+) cells and importantly, patients resistant to treatment with&#xD;
      hypomethylating agents such as azacitidine have an up-regulated expression compared to&#xD;
      responding patients. In addition, it is known that PD-1 promoter demethylation correlates&#xD;
      with a higher PD-1 expression and a worse response rate to hypomethylating agents as well as&#xD;
      a shorter overall survival. In this context it is of note that PD-1 promoter demethylation&#xD;
      can be caused by hypomethylating agents and hence the mode of action of the drug itself could&#xD;
      cause resistance to therapy in these patients. This might also explain why hypomethylating&#xD;
      agents are not curative and can not eradicate early leukemic progenitor cells. The&#xD;
      investigators, therefore, perform a phase II trial evaluating a combination therapy of&#xD;
      pembrolizumab and azacitidine in nucleophosmin (NPM1) mutated AML patients with MRD and&#xD;
      impending hematological relapse after conventional chemotherapy. This trial aims at improving&#xD;
      response rates observed with single agent azacitidine within the studies NCT00422890 and&#xD;
      NCT01462578.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 21, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of event-free patients</measure>
    <time_frame>after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 days every 4 weeks and up to 8 PEM infusions every 3 weeks)</time_frame>
    <description>Events are:&#xD;
First hematological relapse after start of combined therapy&#xD;
Death from any cause&#xD;
AML-treatment other than Pembrolizumab and Azacitidine or hypomethylating agents only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Overall survival is defined as the number of days between date of first visit (AZA) and date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of event-free patients</measure>
    <time_frame>after 12 weeks of combined therapy</time_frame>
    <description>For this endpoint apply the same definitions as for the primary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related mortality</measure>
    <time_frame>during 24 weeks of combined therapy</time_frame>
    <description>Any death without preceding hematologic relapse is considered to be treatment related.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Course of MRD-burden measured as quantitative NPM1/Abelson murine leukemia viral oncogene homolog 1 (ABL) ratio</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>The NPM1/ABL-ratio will be log-transformed with base 10. With the log transformation a near normal distributed variable will be derived to be able to use parametric methods for analysis. Values below limit of detection (LOD) will be substituted by LOD/2 before log-transformation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab + Azacitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab (IMP): 200 mg i.v. (fixed dose) / Azacitidine (SOC): 75 mg/m2 s.c.&#xD;
maximum duration of treatment: up to 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab (IMP): 200mg i.v. (fixed dose), every 3 weeks (Q3W), 8 doses</description>
    <arm_group_label>Pembrolizumab + Azacitidine</arm_group_label>
    <other_name>PEM</other_name>
    <other_name>Keytruda®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Azacitidine (SOC): 75 mg/m2 s.c., day 1-7 every 4 weeks (Q4W), 6 cycles</description>
    <arm_group_label>Pembrolizumab + Azacitidine</arm_group_label>
    <other_name>AZA</other_name>
    <other_name>Vidaza®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patients with NPM1mut AML in complete morphologic remission after conventional&#xD;
             chemotherapy (anthracycline ± cytarabine based)&#xD;
&#xD;
          -  Detectable measurable residual disease (MRD) indicating imminent hematological relapse&#xD;
             (NPM1mut MRD ratio &gt;1%, confirmed by central lab)&#xD;
&#xD;
          -  Patients who are not eligible for immediate allogeneic hematopoietic stem cell&#xD;
             transplantation&#xD;
&#xD;
          -  Patients who are not eligible to undergo alternative intensive treatment&#xD;
&#xD;
          -  Intended AZA therapy for molecular relapse&#xD;
&#xD;
          -  Eastern cooperative oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Demonstrate adequate organ function as defined by protocol, all labs should be&#xD;
             performed within the screening period.&#xD;
&#xD;
          -  Negative pregnancy test in women of childbearing potential (negative urine or serum&#xD;
             pregnancy within 3 days prior to receiving study treatment). If the urine test is&#xD;
             positive or cannot be confirmed as negative, a serum pregnancy test will be required.&#xD;
&#xD;
          -  Female subjects of childbearing potential (Section 5.9.2) must be willing to use an&#xD;
             adequate method of contraception as outlined in Section 5.9.2 - Contraception, for the&#xD;
             course of the study through 120 days after the last dose of study medication. Note:&#xD;
             Abstinence is acceptable if this is the usual lifestyle and preferred contraception&#xD;
             for the subject.&#xD;
&#xD;
          -  Male subjects with procreative capacity (Section 5.9.2) must agree to use an adequate&#xD;
             method of contraception as outlined in Section 5.9.2- Contraception, starting with the&#xD;
             first dose of study therapy through 120 days after the last dose of study therapy.&#xD;
             Note: Abstinence is acceptable if this is the usual lifestyle and preferred&#xD;
             contraception for the subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior allogeneic hematopoietic stem cell transplantation&#xD;
&#xD;
          -  Treatment with any investigational drug within 4 weeks to study therapy or less than 5&#xD;
             half-lives preceding the first dose of trial medication, whichever is longer.&#xD;
&#xD;
          -  Anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or no&#xD;
             recovering (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents&#xD;
             administered more than 4 weeks earlier.&#xD;
&#xD;
          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2&#xD;
             weeks prior to study day 1 or no recovering (i.e., ≤ Grade 1 or at baseline) from&#xD;
             adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2&#xD;
             neuropathy are an exception to this criterion and may qualify for the study. Note: If&#xD;
             subject received major surgery, they must have recovered adequately from the toxicity&#xD;
             and/or complications from the intervention prior to starting therapy.&#xD;
&#xD;
          -  Prior treatment with an anti-programmed cell death protein (anti PD-1, anti PD-L1 or&#xD;
             anti PD-L2 agent).&#xD;
&#xD;
          -  Known hypersensitivity to any of the drugs within this study, their constituents or to&#xD;
             drugs with similar chemical structure.&#xD;
&#xD;
          -  Receiving immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             medication.&#xD;
&#xD;
          -  Known history of active Bacillus Tuberculosis (TB).&#xD;
&#xD;
          -  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.&#xD;
&#xD;
          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.&#xD;
             Subjects with previously treated brain metastases may participate provided they are&#xD;
             stable (without evidence of progression by imaging for at least four weeks prior to&#xD;
             the first dose of trial treatment and any neurologic symptoms have returned to&#xD;
             baseline), have no evidence of new or enlarging brain metastases, and are not using&#xD;
             steroids for at least 7 days prior to trial treatment. This exception does not include&#xD;
             carcinomatous meningitis which is excluded regardless of clinical stability.&#xD;
&#xD;
          -  Autoimmune disease that has required systemic treatment in the past 2 years (i.e. with&#xD;
             use of disease modifying agents, corticosteroids or immunosuppressive drugs).&#xD;
&#xD;
          -  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;
          -  Known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
          -  Liver cirrhosis or malignant liver tumor.&#xD;
&#xD;
          -  Known severe congestive heart failure, incidence of clinically unstable cardiac or&#xD;
             pulmonary disease.&#xD;
&#xD;
          -  Active infection requiring systemic therapy.&#xD;
&#xD;
          -  History or current evidence of any condition, therapy, or laboratory abnormality that&#xD;
             might confound the results of the trial, interfere with the subject's participation&#xD;
             for the full duration of the trial, or is not in the best interest of the subject to&#xD;
             participate, in the opinion of the treating investigator.&#xD;
&#xD;
          -  Known psychiatric or substance abuse disorders that would interfere with cooperation&#xD;
             with the requirements of the trial.&#xD;
&#xD;
          -  Pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment&#xD;
&#xD;
          -  Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., Hepatitis C&#xD;
             virus (HCV) RNA [qualitative] is detected).&#xD;
&#xD;
          -  Live vaccine within 30 days of planned start of study therapy. Note: Seasonal&#xD;
             influenza vaccines for injection are generally inactivated flu vaccines and are&#xD;
             allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated&#xD;
             vaccines, and are not allowed.&#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>Jan Moritz Middeke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technische Universität Dresden (TUD)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uwe Platzbecker, MD</last_name>
    <phone>+49 351 458</phone>
    <phone_ext>7172</phone_ext>
    <email>Uwe.Platzbecker@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna Harig, PhD</last_name>
    <phone>+49 351 458</phone>
    <phone_ext>7172</phone_ext>
    <email>Anna.Harig@ukdd.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias Hänel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Moritz Middeke, MD</last_name>
      <email>JanMoritz.Middeke@ukdd.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard F. Schlenk, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07740</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulf Schnetzke, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Uwe Platzbecker, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf</name>
      <address>
        <city>Mönchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ullrich Graeven, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum r. d. I.</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katharina Götze, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan-Henrik Mikesch, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Kaufmann, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabrina Kraus, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AML</keyword>
  <keyword>NPM1mut</keyword>
  <keyword>molecular relapse</keyword>
  <keyword>pembrolizumab</keyword>
  <keyword>azacitidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Azacitidine</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/NCT03769532
org study id: TUD-PEMAZA-068
nct id: NCT03769532
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation the safety and efficacy of Pembrolizumab (PEM) when administered in combination
      with standard Azacitidine (AZA) in nucleophosmin (NPM1) mutated AML patients with molecular
      relapse defined by the presence of measurable residual disease (MRD).
Azacitidine is an effective and well established therapy in patients with acute myeloid
      leukemia (AML). In fact, in previous measurable residual disease (MRD) triggered studies,
      azacitidine allowed for a delay towards an overt hematological relapse in the majority of
      patients. However, the majority of patients ultimately relapsed even though they received
      multiple cycles of preemptive therapy. Hypomethylating agents (HMA) can enhance antitumor
      immune responses by upregulating tumor antigene expression, class 1 major histocompatibility
      complex, and co-stimulatory molecules, while concurrently dampening this antitumor effect by
      upregulating expression of checkpoint receptors or ligands, including programmed cell death
      protein 1 (PD-1), programmed cell death ligand 1 (PD-L1), and cytotoxic
      T-lymphocyte-associated protein 4 (CTLA-4). Upregulation of these immune checkpoint molecules
      might be a mechanism of resistance to hypomethylating drugs. It has been shown that PD-L1
      Messenger ribonucleic acid (mRNA) is up-regulated acute myeloid leukemia cluster of
      differentiation 34 (CD34+) cells and importantly, patients resistant to treatment with
      hypomethylating agents such as azacitidine have an up-regulated expression compared to
      responding patients. In addition, it is known that PD-1 promoter demethylation correlates
      with a higher PD-1 expression and a worse response rate to hypomethylating agents as well as
      a shorter overall survival. In this context it is of note that PD-1 promoter demethylation
      can be caused by hypomethylating agents and hence the mode of action of the drug itself could
      cause resistance to therapy in these patients. This might also explain why hypomethylating
      agents are not curative and can not eradicate early leukemic progenitor cells. The
      investigators, therefore, perform a phase II trial evaluating a combination therapy of
      pembrolizumab and azacitidine in nucleophosmin (NPM1) mutated AML patients with MRD and
      impending hematological relapse after conventional chemotherapy. This trial aims at improving
      response rates observed with single agent azacitidine within the studies NCT00422890 and
      NCT01462578.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of event-free patients
time frame: after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 days every 4 weeks and up to 8 PEM infusions every 3 weeks)
description: Events are:
First hematological relapse after start of combined therapy
Death from any cause
AML-treatment other than Pembrolizumab and Azacitidine or hypomethylating agents only
measure: Overall survival (OS)
time frame: through study completion, an average of 1 year
description: Overall survival is defined as the number of days between date of first visit (AZA) and date of death from any cause.
measure: Proportion of event-free patients
time frame: after 12 weeks of combined therapy
description: For this endpoint apply the same definitions as for the primary endpoint.
measure: Treatment-related mortality
time frame: during 24 weeks of combined therapy
description: Any death without preceding hematologic relapse is considered to be treatment related.
measure: Course of MRD-burden measured as quantitative NPM1/Abelson murine leukemia viral oncogene homolog 1 (ABL) ratio
time frame: through study completion, an average of 1 year
description: The NPM1/ABL-ratio will be log-transformed with base 10. With the log transformation a near normal distributed variable will be derived to be able to use parametric methods for analysis. Values below limit of detection (LOD) will be substituted by LOD/2 before log-transformation.
arm group label: Pembrolizumab + Azacitidine
arm group type: Experimental
description: Pembrolizumab (IMP): 200 mg i.v. (fixed dose) / Azacitidine (SOC): 75 mg/m2 s.c.
maximum duration of treatment: up to 24 weeks
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab (IMP): 200mg i.v. (fixed dose), every 3 weeks (Q3W), 8 doses
arm group label: Pembrolizumab + Azacitidine
other name: PEM
other name: Keytruda®
intervention type: Drug
intervention name: Azacitidine
description: Azacitidine (SOC): 75 mg/m2 s.c., day 1-7 every 4 weeks (Q4W), 6 cycles
arm group label: Pembrolizumab + Azacitidine
other name: AZA
other name: Vidaza®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Moritz Middeke, MD
role: Principal Investigator
affiliation: Technische Universität Dresden (TUD)
last name: Uwe Platzbecker, MD
phone: +49 351 458
phone ext: 7172
email: Uwe.Platzbecker@medizin.uni-leipzig.de
last name: Anna Harig, PhD
phone: +49 351 458
phone ext: 7172
email: Anna.Harig@ukdd.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Pembrolizumab
mesh term: Azacitidine