<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/NCT03290937</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0180</org_study_id>
    <secondary_id>NCI-2018-01036</secondary_id>
    <secondary_id>2017-0180</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT03290937</nct_id>
  </id_info>
  <brief_title>Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer</brief_title>
  <official_title>Phase I Clinical Trial Evaluating the Safety and Response With PF-05082566, Cetuximab, and Irinotecan in Patients With Advanced Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 phase I trial studies the best dose and side effects of irinotecan hydrochloride when&#xD;
      given with utomilumab and cetuximab in treating patients with colorectal cancer that has&#xD;
      spread to other places in the body (metastatic). Monoclonal antibodies, such as utomilumab&#xD;
      and cetuximab, may interfere with the ability of tumor cells to grow and spread. Drugs used&#xD;
      in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth&#xD;
      of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping&#xD;
      them from spreading. Giving utomilumab, cetuximab, and irinotecan hydrochloride may work&#xD;
      better in treating patients with colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate maximal tolerated dose (MTD), and recommended phase 2 dose (RP2D) of the&#xD;
      combination of utomilumab (PF-05082566), cetuximab and irinotecan hydrochloride (irinotecan)&#xD;
      (PCI) in patients with metastatic colorectal cancer refractory to standard therapy. (Dose&#xD;
      escalation) II. To determine the antitumor activity overall response rate (ORR) by&#xD;
      immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) of the study regimen&#xD;
      specifically in patients with advanced colorectal cancer who are RAS-RAF wild type (WT) (Arm&#xD;
      A) or RAS mutant (Arm B). (Dose expansion)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate overall safety profile. II. To evaluate the anti-tumor activity. III. To&#xD;
      evaluate pharmacodynamics (PD) biomarkers expressed by peripheral blood mononuclear cells&#xD;
      (PBMC) and tissue samples.&#xD;
&#xD;
      IV. To characterize serum biomarkers linked to immunomodulation and cytokine release.&#xD;
&#xD;
      V. To assess markers of T and natural killer (NK) cell phenotype (such as CD3, CD4, CD8,&#xD;
      FoxP3, CD14, CD33, CCR7, CD45RO, CD16, CD56, CD69, CD25, or VCAM1), TNF alpha, IFN gamma,&#xD;
      IL10, IL-8, IL-6, IL-4, IL-2, IL-1b, or IL-12p70, CD127, Ki67, eomesodermin, KLRG1, CD14,&#xD;
      CD33, human leukocyte antigen- D related (HLA-DR), CD16, CD56, granzyme B, CD68, PD-1, CD11c,&#xD;
      sCD137, and 4-1BB.&#xD;
&#xD;
      OUTLINE: This is a dose escalation study of irinotecan hydrochloride.&#xD;
&#xD;
      Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and cetuximab IV&#xD;
      over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every&#xD;
      28 days in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</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>Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>A modified 3+3 design will be used to determine the maximum tolerated dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (Dose expansion)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Assessed by using the immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.03), timing, seriousness and relationship to study therapy utolimumab (PF-05082566); Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will be analyzed using Kaplan-Meier methods and descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 4 years.</time_frame>
    <description>Will be analyzed using Kaplan-Meier methods and descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 4 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Metastatic Colorectal Carcinoma</condition>
  <condition>Stage IV Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IVC Colorectal Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Treatment (irinotecan hydrochloride, cetuximab, utomilumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive irinotecan hydrochloride IV over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (irinotecan hydrochloride, cetuximab, utomilumab)</arm_group_label>
    <other_name>Cetuximab Biosimilar CDP-1</other_name>
    <other_name>Cetuximab Biosimilar CMAB009</other_name>
    <other_name>Cetuximab Biosimilar KL 140</other_name>
    <other_name>Chimeric Anti-EGFR Monoclonal Antibody</other_name>
    <other_name>Chimeric MoAb C225</other_name>
    <other_name>Chimeric Monoclonal Antibody C225</other_name>
    <other_name>Erbitux</other_name>
    <other_name>IMC-C225</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (irinotecan hydrochloride, cetuximab, utomilumab)</arm_group_label>
    <other_name>Campto</other_name>
    <other_name>Camptosar</other_name>
    <other_name>Camptothecin 11</other_name>
    <other_name>Camptothecin-11</other_name>
    <other_name>CPT 11</other_name>
    <other_name>CPT-11</other_name>
    <other_name>Irinomedac</other_name>
    <other_name>Irinotecan Hydrochloride Trihydrate</other_name>
    <other_name>Irinotecan Monohydrochloride Trihydrate</other_name>
    <other_name>U-101440E</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacodynamic Study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (irinotecan hydrochloride, cetuximab, utomilumab)</arm_group_label>
    <other_name>PHARMACODYNAMIC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Utomilumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (irinotecan hydrochloride, cetuximab, utomilumab)</arm_group_label>
    <other_name>PF 05082566</other_name>
    <other_name>PF 5082566</other_name>
    <other_name>PF-05082566</other_name>
    <other_name>PF-2566</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically and or cytologically confirmed metastatic colorectal&#xD;
             cancer&#xD;
&#xD;
          -  Patients must have a wild type or mutated RAS tumor status known prior to enrollment&#xD;
&#xD;
          -  Metastatic colorectal cancer patients have progressed following at least one line of&#xD;
             fluorouracil (5-FU)-based chemotherapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2&#xD;
&#xD;
          -  Patients must have measurable disease per irRECIST criteria for part 2 (dose&#xD;
             expansion)&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1.0 x 10^9/L (1,000/uL)&#xD;
&#xD;
          -  Platelet count &gt;= 75 x 10^9/L (75000/L)&#xD;
&#xD;
          -  Hemoglobin &gt;= 8.0 g/dL (&gt;= 5.0 mmol/L)&#xD;
&#xD;
          -  Patients must be transfusion independent (i.e., no blood product transfusions for a&#xD;
             period of at least 14 days prior to screening)&#xD;
&#xD;
          -  Serum creatinine &lt; 2 x upper limit of normal (ULN) or estimated creatinine clearance &gt;&#xD;
             30 ml/min as calculated using the method standard for the institution&#xD;
&#xD;
          -  Total serum bilirubin &lt; 1.5 x ULN, unless the patient has documented Gilbert syndrome&#xD;
&#xD;
          -  Aspartate and Alanine Aminotransferase (AST and ALT) &lt; 3 x ULN&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) that is greater than 40%, or the absence of&#xD;
             New York Heart Association (NYHA) classification of greater than stage II congestive&#xD;
             heart failure&#xD;
&#xD;
          -  Resolved acute effects of any prior therapy to baseline severity or grade =&lt; 2 Common&#xD;
             Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 except for adverse&#xD;
             events (AEs) not constituting a safety risk by investigator judgment&#xD;
&#xD;
          -  Serum or urine pregnancy test (for females of childbearing potential) negative at&#xD;
             screening and at the baseline visit (before the patient may receive the&#xD;
             investigational product)&#xD;
&#xD;
          -  Male and female patients of childbearing potential and at risk for pregnancy must&#xD;
             agree to use two highly effective methods of contraception throughout the study and&#xD;
             for at least 90 days after the last dose of assigned treatment. Female patients who&#xD;
             are not of childbearing potential (permanently sterilized or postmenopausal; i.e.,&#xD;
             meet at least one of the following criteria):&#xD;
&#xD;
               -  Have undergone a documented hysterectomy and/or bilateral oophorectomy; or&#xD;
&#xD;
               -  Have medically confirmed ovarian failure; or&#xD;
&#xD;
               -  Achieved postmenopausal status, defined as follows: cessation of regular menses&#xD;
                  for at least 12 consecutive months with no alternative pathological or&#xD;
                  physiological cause; status may be confirmed by having a serum follicle&#xD;
                  stimulating hormone (FSH) level within the laboratory's reference range for&#xD;
                  postmenopausal women&#xD;
&#xD;
          -  High microsatellite instability (MSI-H) colorectal cancer patients must have received&#xD;
             an approved PD-1 targeted agent prior to enrolling in this trial&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the patient has been informed of all pertinent aspects of the study&#xD;
&#xD;
          -  Co-consent for protocol LAB10-0982&#xD;
&#xD;
          -  Willingness and ability to comply with the study scheduled visits, treatment plans,&#xD;
             laboratory tests and other procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known symptomatic brain metastases requiring steroids. Patients with&#xD;
             previously diagnosed brain metastases are eligible if they are asymptomatic or have&#xD;
             completed their treatment and have recovered from the acute effects of radiation&#xD;
             therapy or surgery prior to the start of study medication, have discontinued&#xD;
             corticosteroid treatment for these metastases for at least 4 weeks and are&#xD;
             neurologically stable&#xD;
&#xD;
          -  Patient has had any treatment specific for tumor control within 3 weeks of dosing, or&#xD;
             for investigational drugs and cytotoxic agents, within 5 half-lives or 3 weeks,&#xD;
             whichever is shorter&#xD;
&#xD;
          -  Patients receiving any medications or substances that are strong inhibitors or&#xD;
             inducers of CYP3A4 complex. Lists including medications and substances known or with&#xD;
             the potential to interact with the CYP3A4 isoenzymes&#xD;
&#xD;
          -  Prior therapy with a compound of the same mechanism as PF-05082566 (immunomodulation&#xD;
             of 4-1BB)&#xD;
&#xD;
          -  Major surgery within 28 days of starting study treatment&#xD;
&#xD;
          -  Radiation therapy within 14 days of starting study treatment&#xD;
&#xD;
          -  Autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, scleroderma,&#xD;
             systemic lupus erythematosus) and other diseases that compromise or impair the immune&#xD;
             system except patients who have grade 1 psoriasis (in remission or controlled with&#xD;
             topical steroids) or mild degree of autoimmune thyroiditis that are controlled with&#xD;
             medications&#xD;
&#xD;
          -  Active and clinically significant bacterial, fungal or viral infection including&#xD;
             hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or&#xD;
             acquired immunodeficiency syndrome (AIDS)-related illness (HIV testing is not&#xD;
             required)&#xD;
&#xD;
          -  Unstable or serious concurrent medical conditions in the previous 6 months, e.g.,&#xD;
             pancreatitis, severe/unstable angina, prolonged QT interval corrected by Fridericia's&#xD;
             formula (QTcF) &gt; 470 msec (calculated as average of triplicate readings, taken no&#xD;
             greater than 2 minutes apart, and no history of torsades de pointes or symptomatic&#xD;
             corrected QT [QTc] abnormality), symptomatic congestive heart failure, myocardial&#xD;
             infarction and/or pulmonary hypertension, ongoing maintenance therapy for&#xD;
             life-threatening ventricular arrhythmia, stroke, and uncontrolled major seizure&#xD;
             disorder&#xD;
&#xD;
          -  Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ&#xD;
             of the cervix&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients with intolerance to or who have had a severe allergic or anaphylactic&#xD;
             reaction to antibodies or infused therapeutic proteins, or patients who have had a&#xD;
             severe allergic or anaphylactic reaction to any of the substances included in the&#xD;
             study drug (including excipients)&#xD;
&#xD;
          -  Other severe acute or chronic medical or psychiatric condition, including recent&#xD;
             (within the past year) or active suicidal ideation or behavior, or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the patient&#xD;
             inappropriate for entry into this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David S Hong</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D 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>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Camptothecin</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
    <mesh_term>Immunoglobulin G</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/NCT03290937
org study id: 2017-0180
secondary id: NCI-2018-01036
secondary id: 2017-0180
secondary id: P30CA016672
nct id: NCT03290937
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the best dose and side effects of irinotecan hydrochloride when
      given with utomilumab and cetuximab in treating patients with colorectal cancer that has
      spread to other places in the body (metastatic). Monoclonal antibodies, such as utomilumab
      and cetuximab, may interfere with the ability of tumor cells to grow and spread. Drugs used
      in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth
      of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping
      them from spreading. Giving utomilumab, cetuximab, and irinotecan hydrochloride may work
      better in treating patients with colorectal cancer.
PRIMARY OBJECTIVES:

      I. To evaluate maximal tolerated dose (MTD), and recommended phase 2 dose (RP2D) of the
      combination of utomilumab (PF-05082566), cetuximab and irinotecan hydrochloride (irinotecan)
      (PCI) in patients with metastatic colorectal cancer refractory to standard therapy. (Dose
      escalation) II. To determine the antitumor activity overall response rate (ORR) by
      immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) of the study regimen
      specifically in patients with advanced colorectal cancer who are RAS-RAF wild type (WT) (Arm
      A) or RAS mutant (Arm B). (Dose expansion)

      SECONDARY OBJECTIVES:

      I. To evaluate overall safety profile. II. To evaluate the anti-tumor activity. III. To
      evaluate pharmacodynamics (PD) biomarkers expressed by peripheral blood mononuclear cells
      (PBMC) and tissue samples.

      IV. To characterize serum biomarkers linked to immunomodulation and cytokine release.

      V. To assess markers of T and natural killer (NK) cell phenotype (such as CD3, CD4, CD8,
      FoxP3, CD14, CD33, CCR7, CD45RO, CD16, CD56, CD69, CD25, or VCAM1), TNF alpha, IFN gamma,
      IL10, IL-8, IL-6, IL-4, IL-2, IL-1b, or IL-12p70, CD127, Ki67, eomesodermin, KLRG1, CD14,
      CD33, human leukocyte antigen- D related (HLA-DR), CD16, CD56, granzyme B, CD68, PD-1, CD11c,
      sCD137, and 4-1BB.

      OUTLINE: This is a dose escalation study of irinotecan hydrochloride.

      Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and cetuximab IV
      over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every
      28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation)
time frame: Up to 4 years
description: A modified 3+3 design will be used to determine the maximum tolerated dose.
measure: Objective response rate (Dose expansion)
time frame: Up to 4 years
description: Assessed by using the immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
measure: Incidence of adverse events
time frame: Up to 4 years
description: Characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.03), timing, seriousness and relationship to study therapy utolimumab (PF-05082566); Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing.
measure: Progression free survival
time frame: Up to 4 years
description: Will be analyzed using Kaplan-Meier methods and descriptive statistics.
measure: Overall survival
time frame: Up to 4 years.
description: Will be analyzed using Kaplan-Meier methods and descriptive statistics.
measure: Overall response rate
time frame: Up to 4 years
measure: Duration of response
time frame: Up to 4 year
arm group label: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
arm group type: Experimental
description: Patients receive irinotecan hydrochloride IV over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Cetuximab
description: Given IV
arm group label: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
other name: Cetuximab Biosimilar CDP-1
other name: Cetuximab Biosimilar CMAB009
other name: Cetuximab Biosimilar KL 140
other name: Chimeric Anti-EGFR Monoclonal Antibody
other name: Chimeric MoAb C225
other name: Chimeric Monoclonal Antibody C225
other name: Erbitux
other name: IMC-C225
intervention type: Drug
intervention name: Irinotecan Hydrochloride
description: Given IV
arm group label: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
other name: Campto
other name: Camptosar
other name: Camptothecin 11
other name: Camptothecin-11
other name: CPT 11
other name: CPT-11
other name: Irinomedac
other name: Irinotecan Hydrochloride Trihydrate
other name: Irinotecan Monohydrochloride Trihydrate
other name: U-101440E
intervention type: Other
intervention name: Pharmacodynamic Study
description: Correlative studies
arm group label: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
other name: PHARMACODYNAMIC
intervention type: Biological
intervention name: Utomilumab
description: Given IV
arm group label: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
other name: PF 05082566
other name: PF 5082566
other name: PF-05082566
other name: PF-2566
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: David S Hong
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Antineoplastic Agents, Immunological
mesh term: Cetuximab
mesh term: Irinotecan
mesh term: Camptothecin
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal
mesh term: Immunoglobulin G