Phase II Open Label Study of IMMU-132 in Metastatic Urothelial Cancer

  • STATUS
    Recruiting
  • End date
    Aug 24, 2023
  • participants needed
    321
  • sponsor
    Immunomedics, Inc.
Updated on 24 February 2021
Investigator
Allison gladden
Primary Contact
Fakultni' Nemocnice Ostrava (1.3 mi away) Contact
+58 other location
cancer
measurable disease
metastasis
carboplatin
avelumab
pembrolizumab
platinum-based chemotherapy
metastatic urothelial carcinoma

Summary

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 /PD-L1 based immunotherapy.

At least 321 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.

Description

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen and/or anti-PD-1 / PD-L1 based immunotherapy.

The primary objective is Objective Response Rate (ORR) based on central review.

The secondary objectives for Cohorts 1 and 2 are Duration of Response (DOR) and Progression Free Survival (PFS) both based on central review and Overall Survival (OS).

The secondary objectives for Cohort 3 are Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review for Immune-based therapeutics (iRECIST) criteria, Overall Survival (OS), safety and tolerability of IMMU-132 in combination with pembrolizumab.

Cohort 4:

  • DOR, CBR, and PFS based on central review by RECIST 1.1 criteria
  • ORR, DOR, CBR, PFS based on investigator review by RECIST 1.1 criteria
  • OS
  • Safety and tolerability of sacituzumab govitecan in combination with cisplatin

Cohort 5:

  • DOR, CBR, and PFS based on central review by RECIST 1.1 criteria
  • ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 criteria
  • OS
  • Safety and tolerability of sacituzumab govitecan in combination with cisplatin and avelumab

Details
Condition Transitional cell carcinoma, Urothelial Carcinoma
Treatment Sacituzumab govitecan, Sacituzumab govitecan and pembrolizumab, IMMU-132 AND cisplatin, IMMU-132 and cisplatin and avelumab
Clinical Study IdentifierNCT03547973
SponsorImmunomedics, Inc.
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with histologically confirmed urothelial cancer
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
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
Adequate renal and hepatic function
Cohort 4 and 5: Subject has not received any platinum-based chemotherapy in
the metastatic or unresectable locally advanced setting
Adequate hematologic parameters without transfusional support
Creatinine clearance 30mL/min as calculated by the Cockroft-Gault formula
Cohort 4 and 5: Creatinine clearance of at least 50 mL/min calculated by
Subjects must have a 3-month life expectancy
Cockcroft-Gault formula or another validated tool. For subjects receiving
Have measurable disease by CT or MRI as per RECIST 1.1 criteria
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
-day cycle)

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
Cohort 3: Has active autoimmune disease requiring systemic treatment with steroids or other immunosuppressive agent or any condition that in the Investigator's judgment precludes treatment with pembrolizumab
Cohort 3: Has received a live vaccine within 30 days prior to the first dose of study drug(s)
Cohort 3: Has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis
Cohort 3: Has received anti-PD-1/PD-L1 therapy previously
Cohort 4 and 5: Refractory to platinum (i.e., relapsed 12 months after
completion of chemotherapy) in the neoadjuvant/adjuvant setting
Clear my responses

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