Moffitt Cancer Center: Clinical Trial 19988

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Clinical Trial 19988

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

Phase: Phase II
Prinicipal Investigator:

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

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

Summary

Objective

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

Treatments

Therapies

Medications

IMMU-132 ()

Inclusion Criteria

Participants with histologically confirmed urothelial carcinoma. Upper and lower tract tumors are permitted abd mixed histologies are permitted if urothelial carcinoma 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 urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.

Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.

Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer 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.

Adequate renal and hepatic function.

Adequate hematologic parameters without transfusional support.

Creatinine clearance ≥30mL/min as calculated by the Cockroft-Gault formula.

Subjects must have a 3-month life expectancy.

Have measurable disease by CT or MRI as per RECIST 1.1 criteria.

Exclusion Criteria

Women who are pregnant or lactating.

Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

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., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

Requires concomitant medication interfering with ABCA1 transporter or UGT1A1

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

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.