<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/NCT03841110</url>
  </required_header>
  <id_info>
    <org_study_id>FT500-101</org_study_id>
    <nct_id>NCT03841110</nct_id>
  </id_info>
  <brief_title>FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors</brief_title>
  <official_title>FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fate Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fate Therapeutics</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>
      FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive&#xD;
      immunity, and has the potential to overcome multiple mechanisms of immune checkpoint&#xD;
      inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the&#xD;
      clinical investigation of FT500 as monotherapy and in combination with ICI in participants&#xD;
      with advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of participants with Dose Limiting Toxicities (DLTs) within each dose level cohort.</measure>
    <time_frame>Day 29</time_frame>
    <description>The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective-response rate (ORR)</measure>
    <time_frame>Day 29 and every 8 weeks thereafter through Day 366</time_frame>
    <description>ORR is defined as the proportion of participants who achieve immune partial reponse/partial response (iPR/PR) or immune complete response/complete response (iCR/CR). Tumor response will be assessed using modified Response Evaluation Criteria in Solid Tumors (iRECIST) or Response Evaluation Criteria in Lymphoma (RECIL), as applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of FT500 persistence</measure>
    <time_frame>Day 1 through Day 366</time_frame>
    <description>Duration of FT500 response is defined as duration from Day 1 to undetectable levels of FT500 cells per uL blood.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <condition>Lymphoma</condition>
  <condition>Gastric Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <condition>EGFR Positive Solid Tumor</condition>
  <condition>HER2-positive Breast Cancer</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Small Cell Lung Cancer</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Pancreas Cancer</condition>
  <condition>Melanoma</condition>
  <condition>NSCLC</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Cervical Cancer</condition>
  <condition>Microsatellite Instability</condition>
  <condition>Merkel Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>FT500 Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FT500 administered once weekly for 3 weeks as a monotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FT500</intervention_name>
    <description>FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 Monotherapy</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Immune Checkpoint Inhibitor</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <other_name>OPDIVO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Immune Checkpoint Inhibitor</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <other_name>KEYTRUDA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Immune Checkpoint Inhibitor</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <other_name>TECENTRIQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Lympho-conditioning agent</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 Monotherapy</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>Lympho-conditioning agent</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <arm_group_label>FT500 Monotherapy</arm_group_label>
    <arm_group_label>FT500 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IL-2</intervention_name>
    <description>Biologic response modifier</description>
    <arm_group_label>FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor</arm_group_label>
    <other_name>Proleukin</other_name>
    <other_name>Aldesleukin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Diagnosis of the following, as per Regimen Cohort:&#xD;
&#xD;
        1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy,&#xD;
        including lymphoma, in a participant who has failed or refused available FDA-approved&#xD;
        therapies and is now a candidate for salvage therapy.&#xD;
&#xD;
        1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced&#xD;
        solid tumor malignancy, including lymphomas, that has progressed on treatment with at least&#xD;
        one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a participant who has also&#xD;
        failed or refused other available approved therapies and is now a candidate for salvage&#xD;
        therapy.&#xD;
&#xD;
        1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid&#xD;
        tumor malignancy or lymphoma in a participant with disease relapse or progression on an ICI&#xD;
        (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective&#xD;
        USPI.&#xD;
&#xD;
        2. Willingness to provide informed consent as described in the protocol, which includes&#xD;
        compliance with the requirements and restrictions listed in the ICF and in this protocol.&#xD;
&#xD;
        3. Age &gt;18 years old at the time of signing the ICF. 4. Presence of measurable disease by&#xD;
        iRECIST or RECIL criteria, assessed before the start of lympho-conditioning and within 28&#xD;
        days prior to Day 1.&#xD;
&#xD;
        5. Contraceptive use by women or men should be consistent with local regulations regarding&#xD;
        the methods of contraception for those participating in clinical studies.&#xD;
&#xD;
        5a. Female participants: Women of childbearing potential (WOCBP) must use a highly&#xD;
        effective form of contraception from the screening visit until at least 12 months after the&#xD;
        final dose of CY, at least 4 months after the final dose of FT500, at least 4 months after&#xD;
        the final dose of pembrolizumab, and at least 5 months after the final dose of nivolumab or&#xD;
        atezolizumab, whichever is latest.&#xD;
&#xD;
        5b. Male participants: Males must be sterile (biologically or surgically) or use a highly&#xD;
        effective method of contraception from the screening visit until at least 14 months after&#xD;
        the final dose of CY, at least 6 months after the final dose of FT500, at least 6 months&#xD;
        after the final dose of pembrolizumab, and at least 7 months after the final dose of&#xD;
        nivolumab or atezolizumab, whichever is latest.&#xD;
&#xD;
        6. Willingness to comply with study procedures through the planned study duration. For&#xD;
        patients with &gt;1 measurable lesion, agreement to undergo a biopsy from a safely accessible&#xD;
        site per Investigator assessment for exploratory biomarker assessments.&#xD;
&#xD;
        7. Provision of signed and dated ICF to agree to participate, at time of withdrawal or&#xD;
        completion of this study, in Fate Therapeutics' long-term, non-interventional,&#xD;
        observational study, FT-003.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All participants:&#xD;
&#xD;
        1. Females who are pregnant or breastfeeding. 2. ECOG performance status ≥ 2. 3. Evidence&#xD;
        of insufficient organ function as determined by any one of the following: 3a. Neutrophils&#xD;
        &lt;1000/µL or platelets &lt;75,000/µL. 3b. Estimated creatinine clearance &lt;50 mL/minute&#xD;
        (Cockcroft-gault). 3c. Total bilirubin &gt;2 x upper limit normal (ULN) with the exception of&#xD;
        participants with Gilbert's Syndrome or known liver metastases.&#xD;
&#xD;
        3d. Aspartate aminotransferase (AST) &gt;3 x ULN, or alanine aminotransferase (ALT) &gt;3 x ULN.&#xD;
        For participants with known liver metastases, AST or ALT &gt;5 x ULN.&#xD;
&#xD;
        3e. Oxygen saturation &lt;90% on room air. 3f. Left ventricular ejection fraction (LVEF) &lt;40%&#xD;
        (eg by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan).&#xD;
&#xD;
        4.Receipt of any biological therapy, chemotherapy, or radiation (except palliative&#xD;
        radiation) within 2 weeks prior to Day 1. Participants in Regimen B currently taking an ICI&#xD;
        must interrupt ICI dosing at least 2 weeks prior to Day 1.&#xD;
&#xD;
        5. CNS metastases that have not been treated; or treated CNS metastases that have not been&#xD;
        stable for at least 4 weeks.&#xD;
&#xD;
        6. Clinically significant cardiovascular disease, including stroke or myocardial infarction&#xD;
        within 6 months prior to first study medication; or the presence of unstable angina or&#xD;
        congestive heart failure of New York Heart Association grade 2 or higher.&#xD;
&#xD;
        7. Currently receiving or likely to require systemic immunosuppressive therapy (eg,&#xD;
        prednisone &gt;5 mg daily) for any reason from Day -7 to Day 29.&#xD;
&#xD;
        8. Uncontrolled infections. 9. Known allergy to the following FT500 components: Albumin&#xD;
        (Human) or DMSO. 10. Presence of any medical or social issues that are likely to interfere&#xD;
        with study conduct, or may cause increased risk to participant.&#xD;
&#xD;
        11. Any medical condition or clinical laboratory abnormality that, per Investigator or&#xD;
        Medical Monitor judgement, precludes safe participation in and completion of the study, or&#xD;
        that could affect compliance with protocol conduct or interpretation of results.&#xD;
        Participants who have had prior receipt of a Fate Therapeutics investigational human iPSC&#xD;
        product may be eligible for the study with approval from the Medical Monitor.&#xD;
&#xD;
        Additional Exclusion Criteria for Regimen B: FT500 + ICI:&#xD;
&#xD;
        11. Participants who experienced an ICI-related adverse reaction that resulted in&#xD;
        discontinuation of the ICI.&#xD;
&#xD;
        12. Presence or history of autoimmune disease (eg, lupus erythematosus, rheumatoid&#xD;
        arthritis, Addison's disease, autoimmune disease associated with lymphoma, Crohn's disease,&#xD;
        ulcerative colitis), except for participants with isolated vitiligo, atopic dermatitis,&#xD;
        controlled hypoadrenalism or hypopituitarism, and controlled thyroid disease.&#xD;
&#xD;
        13. Participants who have received an allograft organ transplant.&#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>Fate Trial Disclosure</last_name>
    <role>Study Director</role>
    <affiliation>FateTrialDisclosure@fatetherapeutics.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center/John Theurer Cancer Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced Solid Tumor</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Head and Neck</keyword>
  <keyword>Squamous Cell Carcinoma</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>NK cell therapy</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Checkpoint Inhibitor</keyword>
  <keyword>Immune Checkpoint Inhibitor</keyword>
  <keyword>Monoclonal Antibody</keyword>
  <keyword>Cell therapy</keyword>
  <keyword>Cellular therapy</keyword>
  <keyword>nivolumab</keyword>
  <keyword>pembrolizumab</keyword>
  <keyword>atezolizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Merkel Cell</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Microsatellite Instability</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aldesleukin</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Atezolizumab</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/NCT03841110
org study id: FT500-101
nct id: NCT03841110
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive
      immunity, and has the potential to overcome multiple mechanisms of immune checkpoint
      inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the
      clinical investigation of FT500 as monotherapy and in combination with ICI in participants
      with advanced solid tumors.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The incidence of participants with Dose Limiting Toxicities (DLTs) within each dose level cohort.
time frame: Day 29
description: The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).
measure: Objective-response rate (ORR)
time frame: Day 29 and every 8 weeks thereafter through Day 366
description: ORR is defined as the proportion of participants who achieve immune partial reponse/partial response (iPR/PR) or immune complete response/complete response (iCR/CR). Tumor response will be assessed using modified Response Evaluation Criteria in Solid Tumors (iRECIST) or Response Evaluation Criteria in Lymphoma (RECIL), as applicable.
measure: Duration of FT500 persistence
time frame: Day 1 through Day 366
description: Duration of FT500 response is defined as duration from Day 1 to undetectable levels of FT500 cells per uL blood.
arm group label: FT500 Monotherapy
arm group type: Experimental
description: FT500 administered once weekly for 3 weeks as a monotherapy
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
arm group type: Experimental
description: FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group type: Experimental
description: FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
intervention type: Drug
intervention name: FT500
description: FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 Monotherapy
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
intervention type: Drug
intervention name: Nivolumab
description: Immune Checkpoint Inhibitor
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
other name: OPDIVO
intervention type: Drug
intervention name: Pembrolizumab
description: Immune Checkpoint Inhibitor
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
other name: KEYTRUDA
intervention type: Drug
intervention name: Atezolizumab
description: Immune Checkpoint Inhibitor
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
other name: TECENTRIQ
intervention type: Drug
intervention name: Cyclophosphamide
description: Lympho-conditioning agent
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 Monotherapy
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
intervention type: Drug
intervention name: Fludarabine
description: Lympho-conditioning agent
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
arm group label: FT500 Monotherapy
arm group label: FT500 in Combination with Immune Checkpoint Inhibitor
intervention type: Drug
intervention name: IL-2
description: Biologic response modifier
arm group label: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
other name: Proleukin
other name: Aldesleukin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fate Trial Disclosure
role: Study Director
affiliation: FateTrialDisclosure@fatetherapeutics.com
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Merkel Cell
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Melanoma
mesh term: Carcinoma, Squamous Cell
mesh term: Stomach Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Pancreatic Neoplasms
mesh term: Microsatellite Instability
mesh term: Aldesleukin
mesh term: Cyclophosphamide
mesh term: Pembrolizumab
mesh term: Nivolumab
mesh term: Fludarabine
mesh term: Atezolizumab