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Clinical Trial 19988

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

Phase: Phase II
Principal Investigator: Jain, Rohit

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

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.

Objective

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

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

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.

Cohorts 4 and 5: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma must be provided for biomarker testing including PD-L1 and Trop-2.

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 or growth factor support within 2 weeks of study drug initiation

Cohort 4 and 5: Adequate hematology without transfusion support or growth factor support within 2 weeks of study drug initiation (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., > Cohorts 4 and 5: Refractory to platinum (i.e., relapsed >Requires concomitant medications that significantly interfere with ABCA1 transporter or UGT1A1 with no alternate option available

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.

Cohorts 3 to 5: Has received immunosuppressive therapy within 3 years prior to C1D1

Cohorts 1 to 5: Have inability to tolerate or are allergic to sacituzumab govitecan, or CPIs, or are unable or unwilling to receive the doses specified in the protocol

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.