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BRIEF TITLE: Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy

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


  • Org Study ID: IMMU-132-06 - TROPHY U-01
  • Secondary ID:
  • NCT ID: NCT03547973
  • NCT Alias:
  • Sponsor: Immunomedics, Inc. - Industry
  • Source: Immunomedics, Inc.

Brief 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 201 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.

Detailed 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.

Subjects will receive IMMU-132 10 mg/kg administered intravenously on Days 1 and 8 of a
21-day cycle to be continued in the absence of unacceptable toxicity or disease progression.
In Cohort 3, all subjects will first receive IMMU-132 on Days 1 and 8 of a 21-day cycle
followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day
cycle. After discontinuation of treatment, patients will have a 30-day safety follow-up after
last dose and then will be followed every 12 weeks for survival for a maximum of 2 years.

Overal Status Start Date Phase Study Type
Recruiting August 31, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Overall Response Rate (ORR)

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Urothelial Carcinoma

Eligibility

Criteria:
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):

1. Received a first-line platinum-containing regimen in the metastatic setting or
for inoperable locally advanced disease;

2. 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.

- 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

- 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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Trishna Goswami, MD

Role: Study Director

Affiliation: Immunomedics, Inc.

Overall Contact

Name: Allison Gladden

Phone: 862-260-3506

Email: agladden@Immunomedics.com

Locations

Facility Status Contact
Honor Health Research Institute
Avondale, Arizona 85323
United States
Active, not recruiting
American Institute of Research
Tucson, Arizona 85712
United States
Active, not recruiting
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Active, not recruiting
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Active, not recruiting
American Institute of Research
Whittier, California 90603
United States
Terminated
Rocky Mountain Cancer Centers- Littleton
Littleton, Colorado 80120
United States
Recruiting Manojkumar Bupathi, MD
303-730-4700
manojkumar.bupathi@usoncology.com
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510
United States
Active, not recruiting
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Active, not recruiting
Woodlands Medical Specialists
Pensacola, Florida 32503
United States
Active, not recruiting
University of South Florida H. Lee Moffitt Cancer Center & Research Inst.
Tampa, Florida 33612
United States
Recruiting Rohit Jain, MD
888-663-3488
rohit.jain@moffitt.org
Winship Cancer Institute
Atlanta, Georgia 30322
United States
Active, not recruiting
Norton Cancer Institute
Louisville, Kentucky 40241
United States
Active, not recruiting
Maryland Oncology Hematology-Brandywine
Brandywine, Maryland 20613
United States
Active, not recruiting
University of Michigan Comprehensive Medical Center
Ann Arbor, Michigan 48109
United States
Active, not recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Active, not recruiting
University of Mississippi Medical Center
Jackson, Mississippi 38677
United States
Active, not recruiting
Nebraska Cancer Specialists-Midwest Cancer Center-Legacy
Omaha, Nebraska 68130
United States
Active, not recruiting
Urology Cancer Center
Omaha, Nebraska 68130
United States
Active, not recruiting
The Oncology Institute of Hope and Innovation
Henderson, Nevada 89052
United States
Terminated
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89134
United States
Active, not recruiting
New Mexico Oncology Hematology Consultants/Precision Cancer Research
Albuquerque, New Mexico 87109
United States
Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York 14203
United States
Active, not recruiting
Northwell Health
Lake Success, New York 11042
United States
Terminated
New York University Langone Medical
New York, New York 10016
United States
Active, not recruiting
Weill Cornell Medicine
New York, New York 10021
United States
Active, not recruiting
Stony Brook Medicine Cancer Care
Stony Brook, New York 11794
United States
Active, not recruiting
Saint Luke's Cancer Center-Anderson Campus
Easton, Pennsylvania 18045
United States
Active, not recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
Active, not recruiting
Houston Methodist Hospital
Houston, Texas 77030
United States
Active, not recruiting
Renovatio Clinical Consultants
Houston, Texas 77056
United States
Terminated
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Recruiting Maggie Tomasini
210-450-0507
tomasinim@uthscsa.edu
Huntsman Cancer Hospital
Salt Lake City, Utah 84112
United States
Active, not recruiting
Virginia Oncology Associates
Norfolk, Virginia 23666
United States
Active, not recruiting
Blue Ridge Cancer Care
Roanoke, Virginia 24014
United States
Active, not recruiting
Seattle Cancer Care Alliance at South Lake Union
Seattle, Washington 98109
United States
Recruiting Trevor Mamplata
206-606-6365
tmamplata@seattlecca.org
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53705
United States
Active, not recruiting
Les Hopitaux Uiversitaires de Strasbourg
Strasbourg Cedex, Alsace 67091
France
Active, not recruiting
Gustave Roussy
Villejuif, Ile -de-France 94800
France
Active, not recruiting
Institut Clausius Re'gaud
Toulouse, Ile De France
France
Active, not recruiting
Assistance Publique-Hopitaux de Paris Hopital Cochin
Paris, Ile-de-France 75014
France
Active, not recruiting
Hopital Foch
Suresnes, Ile-de-France 92150
France
Active, not recruiting
Centre Le'on Be'rard
Lyon Cedex 08, Rhone-Alpes 69373
France
Active, not recruiting