A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

Study Identifier
M16-300
CT.gov Identifier
NCT03026166
EudraCT Identifier
2016-003686-26
EUCTIS ID
Not available
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Protocol and Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Lung Cancer - Small Cell Lung Cancer (SCLC)
    • Study Drug
  • Ipilimumab
  • Nivolumab
  • Rovalpituzumab tesirine
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, hepatic, and renal function
    Exclusion Criteria:
    * Has active, known, or suspected autoimmune disease * Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug

    Protocol Summary

    The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

    Study Locations

    Location
    Status
    Location
    Ucsd /Id# 161030
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Florida Hospital /ID# 161017
    Orlando, Florida, United States, 32803
    Status
    Not applicable
    Location
    University Cancer & Blood Cent /ID# 161028
    Athens, Georgia, United States, 30607
    Status
    Not applicable
    Location
    University of Chicago /ID# 161006
    Chicago, Illinois, United States, 60637-1443
    Status
    Not applicable
    Location
    The University of Kansas Clini /ID# 162915
    Fairway, Kansas, United States, 66205
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 161011
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
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