<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/NCT03770416</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0510</org_study_id>
    <secondary_id>NCI-2018-02181</secondary_id>
    <secondary_id>2018-0510</secondary_id>
    <nct_id>NCT03770416</nct_id>
  </id_info>
  <brief_title>Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma</brief_title>
  <official_title>Nivolumab and Ibrutinib for Relapsed or Refractory Central Nervous System Lymphoma</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies the side effects and how well nivolumab and ibrutinib works in&#xD;
      treating patients with central nervous system lymphoma that has come back or does not respond&#xD;
      to treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the&#xD;
      body's immune system attack the cancer, and may interfere with the ability of tumor cells to&#xD;
      grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes&#xD;
      needed for cell growth. Giving nivolumab and ibrutinib may work better in treating patients&#xD;
      with central nervous system lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the overall response rate of nivolumab and ibrutinib in central nervous system&#xD;
      (CNS) lymphoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the overall response rate of 4 weeks of ibrutinib single agent in CNS lymphoma.&#xD;
&#xD;
      II. Determine the complete response rate of nivolumab and ibrutinib in CNS lymphoma.&#xD;
&#xD;
      III. Determine the 1-year progression free and overall survival outcomes in CNS lymphoma.&#xD;
&#xD;
      IV. Safety and toxicity of nivolumab and ibrutinib.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Assess activation of T cells in peripheral blood and cerebrospinal fluid. II. Assess the&#xD;
      cytokine profile from microglial cells in cerebrospinal fluid. III. Correlate features of&#xD;
      peripheral blood T cell activation with toxicities. IV. Correlate features of peripheral&#xD;
      blood T cell activation with response and progression free survival (PFS).&#xD;
&#xD;
      V. Correlate baseline tumor characteristics with response and PFS. VI. Evaluate the ability&#xD;
      of minimal residual disease testing to monitor response and differentiate from pseudo&#xD;
      progression.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 cohorts.&#xD;
&#xD;
      COHORT A: Patients receive ibrutinib orally (PO) daily on days 1-28. Beginning course 1,&#xD;
      patients also receive nivolumab intravenously (IV) over 1 hour on days 1 and 15. Treatment&#xD;
      repeats every 28 days for up to 6 courses in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      COHORT B: Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on&#xD;
      days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      Patients who achieve at least a partial response after 6 courses may continue therapy for up&#xD;
      to 2 years.&#xD;
&#xD;
      After completion of study treatment, patients are followed up within 3-4 weeks and then every&#xD;
      3 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Anticipated">June 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
  <phase>Phase 2</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>Overall response rate (ORR)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The overall response rate and its 95% confidence interval will be estimated. Fisher's exact test will be used to evaluate the association between response and other categorical patient variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>At 4 weeks of ibrutinib single agent</time_frame>
    <description>The overall response rate and its 95% confidence interval will be estimated. Fisher's exact test will be used to evaluate the association between response and other categorical patient variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>From study entry to objective disease progression or death from any cause, assessed at 1 year</time_frame>
    <description>Will be estimated using the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From study entry to death, assessed at 1 year</time_frame>
    <description>Will be estimated using the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Baseline up to 30 days after the last dose of study drug</time_frame>
    <description>AE data will be summarized by frequency tables for all patients. For the toxicity endpoint, per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>T cells activation in peripheral blood and cerebrospinal fluid</measure>
    <time_frame>Baseline up to 2 years</time_frame>
    <description>Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. T-test and analysis of variance (ANOVA) will be used to compare outcome measures across patient characteristics. Dunnett's and Tukey's test that properly adjust for multiplicity in multiple tests will be implemented. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cytokine profile from microglial cells in cerebrospinal fluid</measure>
    <time_frame>Baseline up to 2 years</time_frame>
    <description>Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. T-test and ANOVA will be used to compare outcome measures across patient characteristics. Dunnett's and Tukey's test that properly adjust for multiplicity in multiple tests will be implemented. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tumor characteristics</measure>
    <time_frame>Baseline up to 2 years</time_frame>
    <description>Correlation baseline tumor characteristics with response and PFS will be calculated. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Central Nervous System B-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Recurrent Central Nervous System Lymphoma</condition>
  <condition>Refractory Central Nervous System Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ibrutinib PO daily on days 1-28. Beginning course 1, patients also receive nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibrutinib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <other_name>BTK Inhibitor PCI-32765</other_name>
    <other_name>CRA-032765</other_name>
    <other_name>Imbruvica</other_name>
    <other_name>PCI-32765</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Relapsed refractory central nervous system lymphoma, pathology confirmed B cell&#xD;
             lymphoma either by biopsy or by CSF review. Patient must previously have had at least&#xD;
             one line of systemic therapy for CNS lymphoma.&#xD;
&#xD;
          2. Age 18 years or older&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2&#xD;
&#xD;
          4. Patients must have adequate renal and hepatic function&#xD;
&#xD;
               -  Total bilirubin ≤1.5 x upper limit of normal (ULN). For patients with Gilbert's&#xD;
                  disease, total bilirubin up to ≤3 x ULN is allowed provided normal direct&#xD;
                  bilirubin.&#xD;
&#xD;
               -  Serum creatinine ≤1.5 x ULN&#xD;
&#xD;
               -  ALT and AST ≤3 x ULN&#xD;
&#xD;
          5. Females of childbearing potential must have a negative serum or urine beta human&#xD;
             chorionic gonadotrophin (β-hCG) pregnancy test result within 24 hours prior to the&#xD;
             first dose of treatment and must agree to use a highly effective contraception method&#xD;
             during the study and for 23 weeks following the last dose of the study drugs. Females&#xD;
             of non- childbearing potential are those who are postmenopausal greater than 1 year or&#xD;
             who have had a bilateral tubal ligation or hysterectomy. Males who have partners of&#xD;
             childbearing potential must agree to use an effective contraceptive method during the&#xD;
             study and for 31 weeks following the last dose of study drugs. Men must agree not to&#xD;
             donate sperm during and for 3 months after the last dose of study drug. Women who are&#xD;
             pregnant or breastfeeding are ineligible for this study.&#xD;
&#xD;
          6. Patients or their legally authorized representative must provide written informed&#xD;
             consent.&#xD;
&#xD;
          7. Hematology values must be within the following limits:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) 1000/mm3 independent of growth factor support&#xD;
&#xD;
               2. Platelets 100,000/mm3 or 50,000/mm3 if bone marrow involvement independent of&#xD;
                  transfusion support in either situation&#xD;
&#xD;
          8. Creatinine clearance (CrCl) &gt; 30 ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of another primary invasive malignancy that has not been definitively treated&#xD;
             or in remission for at least 2 years. Patients with non-melanoma skin cancers or with&#xD;
             carcinomas in situ are eligible regardless of the time from diagnosis (including&#xD;
             concomitant diagnoses). If patients have another malignancy that was treated within&#xD;
             the last 2 years, such patients may be enrolled if the likelihood of requiring&#xD;
             systemic therapy for this other malignancy within 2 years is less than 10%, as&#xD;
             determined by an expert in that particular malignancy at MD Anderson Cancer Center and&#xD;
             after consultation with the Principal Investigator&#xD;
&#xD;
          2. Any major surgery or wound that has not healed, radiotherapy, cytotoxic chemotherapy,&#xD;
             biologic therapy, immunotherapy, immunomodulatory drugs, experimental therapy within 4&#xD;
             weeks prior to the first dose of the study drugs.&#xD;
&#xD;
          3. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,&#xD;
             congestive heart failure, or myocardial infarction within 6 months of screening, or&#xD;
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association&#xD;
             Functional Classification.&#xD;
&#xD;
          4. History of stroke or cerebral hemorrhage within 6 months of enrollment.&#xD;
&#xD;
          5. Patients who have uncontrolled hypertension (defined as sustained systolic blood&#xD;
             pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg)&#xD;
&#xD;
          6. Prior history of BTK inhibitor or PD1 inhibitor prior to start of trial.&#xD;
&#xD;
          7. Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring&#xD;
             steroid therapy.&#xD;
&#xD;
          8. Patients with autoimmune diseases are excluded: Patients with a history of&#xD;
             Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis) are&#xD;
             excluded from this study as are patients with a history of autoimmune disease (e.g.,&#xD;
             rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus,&#xD;
             Wegener's granulomatosis).&#xD;
&#xD;
          9. Patients with previous allogeneic stem cell transplant (SCT) within 6 months or with&#xD;
             active acute or chronic graft-versus host disease are excluded. Patients must be off&#xD;
             immunosuppression for GVHD for at least 30 days before cycle 1 day 1.&#xD;
&#xD;
         10. Patients with organ allografts (such as renal transplant) are excluded.&#xD;
&#xD;
         11. History of biopsy proven interstitial lung disease or pneumonitis which has impacted&#xD;
             PFT in a clinically significant manner.&#xD;
&#xD;
         12. Patients who are on high dose steroids (&gt;10mg daily of prednisone or equivalent) or&#xD;
             immune suppression medications. Note: Patients on high-dose steroids (doses &gt;10mg/day&#xD;
             of prednisone or equivalent) or immune suppression medications are eligible provided&#xD;
             these drugs are discontinued at least 3 days prior to starting on the study drugs.&#xD;
&#xD;
         13. Patients with uncontrolled active infection (viral, bacterial, and fungal) are not&#xD;
             eligible.&#xD;
&#xD;
         14. Active current hepatitis B or C infection/reactivation as measured by DNA/RNA&#xD;
             quantification, or known seropositivity for HIV.&#xD;
&#xD;
         15. Patient is pregnant or breast-feeding.&#xD;
&#xD;
         16. Malabsorption syndrome or other condition that precludes enteral route of&#xD;
             administration.&#xD;
&#xD;
         17. Concomitant use of warfarin or other Vitamin K antagonists.&#xD;
&#xD;
         18. Requires chronic treatment with a strong cytochrome P450 (CYP) 3A inhibitor (see&#xD;
             Appendix 3).&#xD;
&#xD;
         19. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that in the opinion of the investigator may increase the risk associated&#xD;
             with study participation or investigational product administration or may interfere&#xD;
             with the interpretation of study results and/or would make the patient inappropriate&#xD;
             for enrollment into this study.&#xD;
&#xD;
         20. Vaccinated with live, attenuated vaccines within 4 weeks of enrollment.&#xD;
&#xD;
         21. Any life-threatening illness, medical condition, or organ system dysfunction which, in&#xD;
             the investigator's opinion, could compromise the subject's safety, interfere with the&#xD;
             absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue&#xD;
             risk.&#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>Jason Westin, MD</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>M D Anderson Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</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/NCT03770416
org study id: 2018-0510
secondary id: NCI-2018-02181
secondary id: 2018-0510
nct id: NCT03770416
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This phase II trial studies the side effects and how well nivolumab and ibrutinib works in
      treating patients with central nervous system lymphoma that has come back or does not respond
      to treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the
      body's immune system attack the cancer, and may interfere with the ability of tumor cells to
      grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving nivolumab and ibrutinib may work better in treating patients
      with central nervous system lymphoma.
PRIMARY OBJECTIVES:

      I. Determine the overall response rate of nivolumab and ibrutinib in central nervous system
      (CNS) lymphoma.

      SECONDARY OBJECTIVES:

      I. Determine the overall response rate of 4 weeks of ibrutinib single agent in CNS lymphoma.

      II. Determine the complete response rate of nivolumab and ibrutinib in CNS lymphoma.

      III. Determine the 1-year progression free and overall survival outcomes in CNS lymphoma.

      IV. Safety and toxicity of nivolumab and ibrutinib.

      EXPLORATORY OBJECTIVES:

      I. Assess activation of T cells in peripheral blood and cerebrospinal fluid. II. Assess the
      cytokine profile from microglial cells in cerebrospinal fluid. III. Correlate features of
      peripheral blood T cell activation with toxicities. IV. Correlate features of peripheral
      blood T cell activation with response and progression free survival (PFS).

      V. Correlate baseline tumor characteristics with response and PFS. VI. Evaluate the ability
      of minimal residual disease testing to monitor response and differentiate from pseudo
      progression.

      OUTLINE: Patients are assigned to 1 of 2 cohorts.

      COHORT A: Patients receive ibrutinib orally (PO) daily on days 1-28. Beginning course 1,
      patients also receive nivolumab intravenously (IV) over 1 hour on days 1 and 15. Treatment
      repeats every 28 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      COHORT B: Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on
      days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      Patients who achieve at least a partial response after 6 courses may continue therapy for up
      to 2 years.

      After completion of study treatment, patients are followed up within 3-4 weeks and then every
      3 months for 2 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: Up to 2 years
description: The overall response rate and its 95% confidence interval will be estimated. Fisher's exact test will be used to evaluate the association between response and other categorical patient variables.
measure: ORR
time frame: At 4 weeks of ibrutinib single agent
description: The overall response rate and its 95% confidence interval will be estimated. Fisher's exact test will be used to evaluate the association between response and other categorical patient variables.
measure: Progression free survival (PFS)
time frame: From study entry to objective disease progression or death from any cause, assessed at 1 year
description: Will be estimated using the method of Kaplan and Meier.
measure: Overall survival
time frame: From study entry to death, assessed at 1 year
description: Will be estimated using the method of Kaplan and Meier.
measure: Incidence of adverse events (AEs)
time frame: Baseline up to 30 days after the last dose of study drug
description: AE data will be summarized by frequency tables for all patients. For the toxicity endpoint, per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
measure: T cells activation in peripheral blood and cerebrospinal fluid
time frame: Baseline up to 2 years
description: Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. T-test and analysis of variance (ANOVA) will be used to compare outcome measures across patient characteristics. Dunnett's and Tukey's test that properly adjust for multiplicity in multiple tests will be implemented. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
measure: Cytokine profile from microglial cells in cerebrospinal fluid
time frame: Baseline up to 2 years
description: Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. T-test and ANOVA will be used to compare outcome measures across patient characteristics. Dunnett's and Tukey's test that properly adjust for multiplicity in multiple tests will be implemented. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
measure: Tumor characteristics
time frame: Baseline up to 2 years
description: Correlation baseline tumor characteristics with response and PFS will be calculated. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square (c2) test or Fisher's exact test will be used to test the association between two categorical variables such as disease state and performance status.
arm group label: Cohort A
arm group type: Experimental
description: Patients receive ibrutinib PO daily on days 1-28. Beginning course 1, patients also receive nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.
arm group label: Cohort B
arm group type: Experimental
description: Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years.
intervention type: Drug
intervention name: Ibrutinib
description: Given PO
arm group label: Cohort A
arm group label: Cohort B
other name: BTK Inhibitor PCI-32765
other name: CRA-032765
other name: Imbruvica
other name: PCI-32765
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: Cohort A
arm group label: Cohort B
other name: BMS-936558
other name: MDX-1106
other name: NIVO
other name: ONO-4538
other name: Opdivo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Westin, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: M D Anderson Cancer Center
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Nivolumab