<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/NCT03816345</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2019-00241</org_study_id>
    <secondary_id>NCI-2019-00241</secondary_id>
    <secondary_id>10204</secondary_id>
    <secondary_id>10204</secondary_id>
    <secondary_id>UM1CA186688</secondary_id>
    <nct_id>NCT03816345</nct_id>
  </id_info>
  <brief_title>Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer</brief_title>
  <official_title>A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</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 Ib trial studies the side effects of nivolumab and to see how well it works in&#xD;
      treating patients with autoimmune disorders and cancer that has spread to other places in the&#xD;
      body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as&#xD;
      nivolumab, may help the body's immune system attack the cancer, and may interfere with the&#xD;
      ability of tumor cells to grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To assess the overall safety, and toxicities associated with the use of the&#xD;
      anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of&#xD;
      dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus&#xD;
      erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis [UC] and Crohn's&#xD;
      disease [CD]), multiple sclerosis (MS), Sjogren's syndrome [SjS], Psoriasis (PsO)/Psoriatic&#xD;
      Arthritis (PsA), and other autoimmune diseases.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs),&#xD;
      progression-free survival (PFS), and overall survival (OS) in patients with cancer and&#xD;
      DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases.&#xD;
&#xD;
      II. To observe and record anti-tumor activity. III. To propose dosing recommendations for&#xD;
      anti-PD-1 antibodies based on the severity of the autoimmune disorder.&#xD;
&#xD;
      IV. To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE,&#xD;
      IBD: UC and CD, not specified (NS), MS, SjS, PsO/PsA.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years&#xD;
      in the absence of disease progression or unacceptable toxicity. Patients also undergo&#xD;
      collection of tissue, blood, and cerebral spinal fluid (CSF) on study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 100 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>Incidence of adverse events</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in disease assessments</measure>
    <time_frame>Baseline up to 100 days</time_frame>
    <description>Will be summarized at each time point for each disease severity cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in serum chemokines and circulating immune cells over time</measure>
    <time_frame>Baseline up to 100 days</time_frame>
    <description>Will be summarized and assessed using generalized linear mixed modeling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gene expression in normal tissues</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Will be compared with gene expression in malignant tissues based on two-sample t-test and Wilcoxon rank sum test. False discovery rate, if appropriate, will be used to control for multiple testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical measures of interest</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>The association between demographic and clinical measures of interest with overall response rate and toxicity will be evaluated using logistic regression modeling to identify potential predictors of outcomes.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Advanced Malignant Solid Neoplasm</condition>
  <condition>Autoimmune Disease</condition>
  <condition>Crohn Disease</condition>
  <condition>Dermatomyositis</condition>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <condition>Metastatic Malignant Solid Neoplasm</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Psoriasis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Sjogren Syndrome</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Systemic Scleroderma</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Unresectable Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Treatment (nivolumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue, blood, and cerebral spinal fluid (CSF) on study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood, CSF, tissue, stool and urine samples</description>
    <arm_group_label>Treatment (nivolumab)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (nivolumab)</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>CMAB819</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>Nivolumab Biosimilar CMAB819</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients can have either histologically confirmed malignancy that is radiologically&#xD;
             evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1&#xD;
             inhibitor has been approved in the adjuvant setting. Eligible tumor types include&#xD;
             solid tumors and malignancies in which there is known evidence of clinical activity&#xD;
             for single agent PD-1 or PD-L1 antibodies. Nivolumab is Food and Drug Administration&#xD;
             (FDA)-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC),&#xD;
             Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer,&#xD;
             hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin&#xD;
             lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with&#xD;
             microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible&#xD;
             but must follow standard response criteria. Additional tumor types may be eligible on&#xD;
             a case by case basis upon discussion with principal investigator (PI). Patients&#xD;
             enrolling on the trial for adjuvant use will be restricted to those with histology for&#xD;
             which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but&#xD;
             not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer&#xD;
&#xD;
          -  Patients who have previously received other forms of immunotherapy (high-dose [HD]&#xD;
             IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy&#xD;
             for at least 4 weeks before nivolumab administration. Patients who have received prior&#xD;
             anti-CTLA4 will be allowed and the washout period is 6 weeks&#xD;
&#xD;
          -  Age &gt;= 18 years; children are excluded from this study but may be eligible for future&#xD;
             pediatric phase 1 combination trials&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky &gt;=&#xD;
             60)&#xD;
&#xD;
          -  Life expectancy of greater than 12 weeks&#xD;
&#xD;
          -  Leukocytes &gt;= 1,000/mcL&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 500/mcL&#xD;
&#xD;
          -  Platelets &gt;= 50,000/mcL&#xD;
&#xD;
          -  Total bilirubin =&lt; 2 x institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 5 x institutional ULN or &lt; 8 x institutional ULN for patients with liver metastases&#xD;
             or an autoimmune disease that is contributing to the elevation of these values&#xD;
&#xD;
          -  Creatinine ULN OR glomerular filtration rate (GFR) &gt;= 30 mL/min (if using the&#xD;
             Cockcroft-Gault formula)&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral&#xD;
             therapy with undetectable viral load within 6 months are eligible for this trial&#xD;
&#xD;
          -  If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be&#xD;
             undetectable on suppressive therapy if indicated&#xD;
&#xD;
          -  If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV&#xD;
             viral load&#xD;
&#xD;
          -  Patients with new or progressive brain metastases (active brain metastases) or&#xD;
             leptomeningeal disease are eligible if the treating physician determines that&#xD;
             immediate central nervous system (CNS) specific treatment is not required and is&#xD;
             unlikely to be required for at least 4 weeks (or scheduled assessment after the first&#xD;
             cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the&#xD;
             investigator favors participation in the clinical trial&#xD;
&#xD;
          -  The effects of nivolumab on the developing human fetus are unknown. For this reason,&#xD;
             women of child-bearing potential (WOCBP) and men must agree to use adequate&#xD;
             contraception (hormonal or barrier method of birth control; abstinence) prior to study&#xD;
             entry and for the duration of study participation. WOCBP receiving nivolumab will be&#xD;
             instructed to adhere to contraception for a period of 5 months after the last dose of&#xD;
             investigational product. Men receiving nivolumab and who are sexually active with&#xD;
             WOCBP will be instructed to adhere to contraception for a period of 7 months after the&#xD;
             last dose of investigational product. Women of childbearing potential must have a&#xD;
             negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent&#xD;
             units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of&#xD;
             nivolumab. Women must not be breastfeeding. Women who are not of childbearing&#xD;
             potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic&#xD;
             men) do not require contraception. WOCBP is defined as any female who has experienced&#xD;
             menarche and who has not undergone surgical sterilization (hysterectomy or bilateral&#xD;
             oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12&#xD;
             months of amenorrhea in a woman over 45 in the absence of other biological or&#xD;
             physiological causes. In addition, women under the age of 55 must have a documented&#xD;
             serum follicle stimulating hormone (FSH) level less than 40 mIU/mL. These durations&#xD;
             have been calculated using the upper limit of the half-life for nivolumab (25 days)&#xD;
             and are based on the protocol requirement that WOCBP use contraception for 5&#xD;
             half-lives plus 30 days, and men who are sexually active with WOCBP use contraception&#xD;
             for 5 half-lives plus 90 days. Should a woman become pregnant or suspect she is&#xD;
             pregnant while she or her partner is participating in this study, she (or the&#xD;
             participating partner) should inform the treating physician immediately&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
          -  Patients with more than one autoimmune disease are eligible. The treating physician&#xD;
             would determine which autoimmune disease is dominant and the patient would be treated&#xD;
             under that specific cohort&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for&#xD;
             nitrosoureas or mitomycin C) prior to entering the study or those who have not&#xD;
             recovered from adverse events (AEs) due to agents administered more than 4 weeks&#xD;
             earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy&#xD;
             (RT) is permitted (2 week washout from start of treatment), if all of the following&#xD;
             criteria are met:&#xD;
&#xD;
               -  Repeat imaging demonstrates no new sites of bone metastases&#xD;
&#xD;
               -  The lesion being considered for palliative radiation is not a target lesion&#xD;
&#xD;
          -  Patients with prior therapy with an anti-PD-1 or anti-PD-L1&#xD;
&#xD;
          -  Patients with prior allogeneic hematologic transplant&#xD;
&#xD;
          -  Patients who are receiving any other anticancer investigational agents&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Patients who have had evidence of active or acute diverticulitis, intra-abdominal&#xD;
             abscess, gastrointestinal (GI) bleeding, obstruction, and abdominal carcinomatosis&#xD;
             which are known risk factors for bowel perforation should be evaluated for the&#xD;
             potential need for additional treatment before coming on study. For the IBD (UC and&#xD;
             CD) cohort, an endoscopic assessment, disease activity index, and disease specific&#xD;
             inclusion/exclusion criteria will substitute for these factors in determining&#xD;
             eligibility with the exception of abdominal carcinomatosis, which should prompt&#xD;
             further evaluation&#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>Hussein A Tawbi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas MD Anderson Cancer Center LAO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Center/Yale-New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>203-785-5702</phone>
      <email>canceranswers@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Patricia M. LoRusso</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>203-785-5702</phone>
      <email>canceranswers@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Patricia M. LoRusso</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-695-1301</phone>
      <email>cancer@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Jeffrey A. Sosman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Walter M. Stadler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Clinical Research Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HaysMed University of Kansas Health System</name>
      <address>
        <city>Hays</city>
        <state>Kansas</state>
        <zip>67601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>785-623-5774</phone>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lawrence Memorial Hospital</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>785-505-2800</phone>
      <email>Stephanie.Norris@LMH.ORG</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Olathe Health Cancer Center</name>
      <address>
        <city>Olathe</city>
        <state>Kansas</state>
        <zip>66061</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-355-8000</phone>
      <email>Jeni.wakefield@olathehealth.org</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center-Overland Park</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital-Indian Creek Campus</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi - Pittsburg</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>620-235-7900</phone>
      <email>jennifer.jameson@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Salina Regional Health Center</name>
      <address>
        <city>Salina</city>
        <state>Kansas</state>
        <zip>67401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>785-452-7038</phone>
      <email>mleepers@srhc.com</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Health System Saint Francis Campus</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>785-295-8000</phone>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital-Westwood Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Julie R. Brahmer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute Developmental Therapeutics Clinic</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-411-1222</phone>
    </contact>
    <investigator>
      <last_name>A P. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-411-1222</phone>
    </contact>
    <investigator>
      <last_name>A P. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-726-5130</phone>
    </contact>
    <investigator>
      <last_name>Patrick A. Ott</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-442-3324</phone>
    </contact>
    <investigator>
      <last_name>Patrick A. Ott</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wayne State University/Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>313-576-9790</phone>
      <email>ctoadmin@karmanos.org</email>
    </contact>
    <investigator>
      <last_name>Mohammed N. Al Hallak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Tanner M. Johanns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Truman Medical Centers</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>816-404-4375</phone>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center - North</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center - Lee's Summit</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center at North Kansas City Hospital</name>
      <address>
        <city>North Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Joaquina C. Baranda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Tanner M. Johanns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center-South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Tanner M. Johanns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Christian Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Tanner M. Johanns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Tanner M. Johanns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CancerTrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Janice M. Mehnert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-305-6361</phone>
      <email>nr2616@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Brian S. Henick</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-746-1848</phone>
    </contact>
    <investigator>
      <last_name>Jones T. Nauseef</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-293-5066</phone>
      <email>Jamesline@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Yuanquan Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-647-8073</phone>
    </contact>
    <investigator>
      <last_name>Yana Najjar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Simmons Cancer Center - RedBird</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@utsouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Hans Hammers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Hans Hammers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Hans Hammers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-632-6789</phone>
      <email>askmdanderson@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Ecaterina E. Dumbrava</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Clinical Center at Richardson/Plano</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>972-669-7044</phone>
      <email>Suzanne.cole@utsouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Hans Hammers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Andrew Poklepovic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Health Network-Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>416-946-4501</phone>
      <email>clinical.trials@uhn.on.ca</email>
    </contact>
    <investigator>
      <last_name>Anna Spreafico</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 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>Neoplasms</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page</ipd_description>
    <ipd_url>https://grants.nih.gov/policy/sharing.htm</ipd_url>
  </patient_data>
  <!-- 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/NCT03816345
org study id: NCI-2019-00241
secondary id: NCI-2019-00241
secondary id: 10204
secondary id: 10204
secondary id: UM1CA186688
nct id: NCT03816345
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase Ib trial studies the side effects of nivolumab and to see how well it works in
      treating patients with autoimmune disorders and cancer that has spread to other places in the
      body or cannot removed by surgery. 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.
PRIMARY OBJECTIVE:

      I. To assess the overall safety, and toxicities associated with the use of the
      anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of
      dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus
      erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis [UC] and Crohn's
      disease [CD]), multiple sclerosis (MS), Sjogren's syndrome [SjS], Psoriasis (PsO)/Psoriatic
      Arthritis (PsA), and other autoimmune diseases.

      SECONDARY OBJECTIVES:

      I. To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs),
      progression-free survival (PFS), and overall survival (OS) in patients with cancer and
      DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases.

      II. To observe and record anti-tumor activity. III. To propose dosing recommendations for
      anti-PD-1 antibodies based on the severity of the autoimmune disorder.

      IV. To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE,
      IBD: UC and CD, not specified (NS), MS, SjS, PsO/PsA.

      OUTLINE:

      Patients receive nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years
      in the absence of disease progression or unacceptable toxicity. Patients also undergo
      collection of tissue, blood, and cerebral spinal fluid (CSF) on study.

      After completion of study treatment, patients are followed up for 100 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events
time frame: Up to 100 days
description: Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
measure: Change in disease assessments
time frame: Baseline up to 100 days
description: Will be summarized at each time point for each disease severity cohort.
measure: Overall response rate
time frame: Up to 100 days
description: Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.
measure: Changes in serum chemokines and circulating immune cells over time
time frame: Baseline up to 100 days
description: Will be summarized and assessed using generalized linear mixed modeling.
measure: Gene expression in normal tissues
time frame: Up to 100 days
description: Will be compared with gene expression in malignant tissues based on two-sample t-test and Wilcoxon rank sum test. False discovery rate, if appropriate, will be used to control for multiple testing.
measure: Clinical measures of interest
time frame: Up to 100 days
description: The association between demographic and clinical measures of interest with overall response rate and toxicity will be evaluated using logistic regression modeling to identify potential predictors of outcomes.
arm group label: Treatment (nivolumab)
arm group type: Experimental
description: Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue, blood, and cerebral spinal fluid (CSF) on study.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood, CSF, tissue, stool and urine samples
arm group label: Treatment (nivolumab)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: Treatment (nivolumab)
other name: BMS-936558
other name: CMAB819
other name: MDX-1106
other name: NIVO
other name: Nivolumab Biosimilar CMAB819
other name: ONO-4538
other name: Opdivo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hussein A Tawbi
role: Principal Investigator
affiliation: University of Texas MD Anderson Cancer Center LAO
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status: Active, not recruiting
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Sjogren's Syndrome
mesh term: Dermatomyositis
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
mesh term: Multiple Sclerosis
mesh term: Lupus Erythematosus, Systemic
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Autoimmune Diseases
mesh term: Nivolumab
sharing ipd: Yes
ipd description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
ipd url: https://grants.nih.gov/policy/sharing.htm