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Clinical Trial 19988

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03547973

Phase: Phase II
Principal Investigator: Jain, Rohit

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Study Title

A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy


This is a phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 /PD-L1 based immunotherapy.


The objectives of this study is to evaluate the efficacy and safety of IMMU-132 in previously treated metastatic urothelial cancers.



Immunotherapy; Therapy (NOS)


Avelumab (); IMMU-132 (); MSB00100718C (Avelumab); Pembrolizumab (Keytruda); Sacituzumab Govitecan (); cisplatin ()

Inclusion Criteria

  • Participants with histologically confirmed UC. Upper and lower tract tumors are permitted and mixed histologies are permitted if UC is the predominant histology
  • ECOG Performance status score of 0 or 1.
  • Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  • Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  • Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive UC, with recurrence/progression >Cohort 1: In addition to above criterion, have had progression or recurrence of UC following receipt of an anti-PD-1 /PD-L1 therapy.
  • Cohort 2: Were ineligible for platinum-based therapy and have had progression or recurrence of UC after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
  • Cohort 3: Progression or recurrence of UC following a platinum -containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
  • Cohort 4 and 5: Cisplatin-eligible subject who has not received any therapy, specifically platinum-based chemotherapy in the metastatic or unresectable locally advanced setting
  • Cohorts 1 to 3: Adequate hematology without transfusion support,
  • Cohort 4 and 5: Total WBC count must be >4000 per mm3, ANC >1500 per mm3, platelets >100,000 per mcL, and hemoglobin >9 g/dL.
  • Cohort 4 and 5: Creatinine clearance of at least 50 mL/min calculated by Cockcroft–Gault formula or another validated tool. For subjects receiving cisplatin at 70 mg/m2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft –Gault formula or another validated tool is required. Subjects with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m2 Day 1 and Day 8 of every 21-day cycle).
  • Adequate renal and hepatic function.
  • Adequate hematologic parameters without transfusional support.
  • Creatinine clearance > Subjects must have a 3-month life expectancy.
  • Have measurable disease by CT or MRI as per RECIST 1.1 criteria.
  • Participant must be willing and able to comply with all protocol requirements

  • Exclusion Criteria

  • Women who are pregnant or lactating.
  • Has had a prior anti-cancer mAb within 4 weeks prior to study Day 1 or who has not recovered (i.e.,>Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., > Cohort 4 and 5: Refractory to platinum (i.e., relapsed >Requires concomitant medications that significantly interfere with ABCA1 transporter or UGT1A1 with no alternate option availble
  • Has an active second malignancy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has known active Hepatitis B or Hepatitis C
  • Cohorts 4 and 5: Hypersensitivity or anaphylaxis to cisplatin.
  • Cohorts 4 and 5: >Grade 2 hearing loss.
  • Cohorts 4 and 5: >Grade 2 peripheral neuropathy.
  • Has other concurrent medical or psychiatric conditions

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.