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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 140 patients are anticipated to be enrolled across approximately 70 sites from North America, Europe and Asia.

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 are Duration of Response (DOR) and Progression Free Survival (PFS)
both based on central review and Overall Survival (OS).

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 progression of
disease requiring termination of further treatment. 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 minimum 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.

- 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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Trishna Goswami, MD

Role: Study Chair

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
Not yet recruiting Rebecca Martin
623-238-7330
rebecca.martin@honorhealth.com
American Institute of Research
Tucson, Arizona 85712
United States
Recruiting Kirsten Bettino
562-693-4477
kbettino@airesearch.us
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Not yet recruiting Srinath Sundararajan, MD
520-626-5972
ssundararajan@email.arizona.edu
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Not yet recruiting Cheryl Kefauver
323-865-0845
cheryl.kefauver@med.usc.edu
American Institute of Research
Whittier, California 90603
United States
Recruiting Kirsten Bettino
562-693-4477
kbettino@airesearch.us
Rocky Mountain Cancer Centers- Littleton
Littleton, Colorado 80120
United States
Not yet recruiting Manojkumar Bupathi, MD
303-730-4700
manojkumar.bupathi@usoncology.com
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510
United States
Recruiting Ebony Williams
203-785-5720
ebony.williams@yale.edu
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Not yet recruiting Yvonne Enriquez-Nunez
305-674-2625
yenrique@msmc.com
Woodlands Medical Specialists
Pensacola, Florida 32503
United States
Not yet recruiting Rami Owera, MD
850-696-4423
rami.owera@usoncology.com
University of South Florida H. Lee Moffitt Cancer Center & Research Inst.
Tampa, Florida 33612
United States
Not yet recruiting Rohit Jain, MD
888-663-3488
rohit.jain@moffitt.org
Winship Cancer Institute
Atlanta, Georgia 30322
United States
Not yet recruiting Bradley Carthon, MD
404-778-1900
bcartho@emory.edu
Norton Cancer Institute
Louisville, Kentucky 40241
United States
Recruiting Doris Perez Diaz
502-629-6068
Doris.PerezDiaz@nortonhealchcare.org
Maryland Oncology Hematology-Brandywine
Brandywine, Maryland 20613
United States
Recruiting Maggie Johannesen
240-826-2118
margaret.johannesen@usoncology.com
University of Michigan Comprehensive Medical Center
Ann Arbor, Michigan 48109
United States
Recruiting Brandy Slusser
734-936-9499
slusserb@med.umich.edu
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Not yet recruiting Brenda Dickow
313-576-9372
dickowb@karmanos.org
University of Mississippi Medical Center
Jackson, Mississippi 38677
United States
Recruiting John Henegan, MD
601-984-5590
jhenegan@umc.edu
Nebraska Cancer Specialists-Midwest Cancer Center-Legacy
Omaha, Nebraska 68130
United States
Not yet recruiting Ralph Hauke, MD
402-691-6971
rhauke@nebraskacancer.com
Urology Cancer Center
Omaha, Nebraska 68130
United States
Recruiting Stacy Moore
402-697-2229
smoore@gucancer.com
The Oncology Institute of Hope and Innovation
Henderson, Nevada 89052
United States
Recruiting Kirsten Bettino
562-693-4477
kbettino@airesearch.us
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89134
United States
Recruiting Alissa Dent
702-952-3712
alissa.dent@usoncology.com
New Mexico Oncology Hematology Consultants/Precision Cancer Research
Albuquerque, New Mexico 87109
United States
Recruiting Ezequiel Cambranis
505-842-8171
ezequielc@nmohc.com
Roswell Park Cancer Institute
Buffalo, New York 14203
United States
Recruiting Jessica Doersam
716-845-3019
Jessica.Doersam@RoswellPark.org
Northwell Health
Lake Success, New York 11042
United States
Not yet recruiting Sally Flores
516-734-8916
sflores3@northwell.edu
New York University Langone Medical
New York, New York 10016
United States
Recruiting Jessica Chaisson
929-455-2436
Jessica.Chaisson@nyulangone.org
Weill Cornell Medicine
New York, New York 10021
United States
Recruiting Pryianka Patel

prp2013@med.cornell.edu
Stony Brook Medicine Cancer Care
Stony Brook, New York 11794
United States
Recruiting Audrey Anderson
631-638-0829
audrey.anderson@stonybrookmedicine.edu
Saint Luke's Cancer Center-Anderson Campus
Easton, Pennsylvania 18045
United States
Recruiting Megan Gavinski
484-503-4157
megan.gavinski@sluhn.org
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
Recruiting Anna Dumont
615-936-5173
anna.dumont@vumc.org
Houston Methodist Hospital
Houston, Texas 77030
United States
Not yet recruiting Syed Saad
281-481-8557
ssaad@accurateclinicalresearch.com
Renovatio Clinical Consultants
Houston, Texas 77056
United States
Recruiting Alice Mouton
832-703-9054
alice.mouton@renovatioclinical.com
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Not yet recruiting Maggie Tomasini
210-450-0507
tomasinim@uthscsa.edu
Huntsman Cancer Hospital
Salt Lake City, Utah 84112
United States
Recruiting Kristen Jones
801-213-6125
Kristen.Jones@hci.utah.edu
Virginia Oncology Associates
Norfolk, Virginia 23666
United States
Not yet recruiting Mark Fleming
757-466-8683
mark.fleming@usoncology.com
Blue Ridge Cancer Care
Roanoke, Virginia 24014
United States
Not yet recruiting Mark Kochenderfer, MD
540-982-0237
mark.kochenderfer@usoncology.com
Seattle Cancer Care Alliance at South Lake Union
Seattle, Washington 98109
United States
Recruiting Kelly Crowder
206-606-7486
kcrowder@seattlecca.org
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53705
United States
Not yet recruiting Jennifer Engel-Diaz
608-263-7107
jjengel2@wisc.edu
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen 2650
Belgium
Not yet recruiting Ines Van Hemeldonck
+3238215681
ines.vanhemeldonck@uza.be
Institut Jules Bordet
Bruxelles, Brussels 1070
Belgium
Not yet recruiting Sylvie Bartholomeus
+3225413234
sylvie.bartholomeus@bordet.be
Grand Hopital de Charleroi-Notre Dame
Charleroi, Hainaut 6000
Belgium
Not yet recruiting Christy Van der Perren
+3271877178
cvdperren@gmail.com
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, 2020
Belgium
Not yet recruiting Abdelbari Baitar
+3232803130
abdelbari.baitar@zna.be
Thomayerova Nemocnice
Prague, Praha 140 59
Czechia
Not yet recruiting Jaroslava Skalova
+420731195690
jaroslava.skalova@ftn.cz
Fakultni' Nemocnice Na Bulovce
Prague, Praha 180 00
Czechia
Not yet recruiting Barbora Vondraskova
+420266084154
barbora.vondraskova@bulovka.cz
Fakultni' Nemocnice Ostrava
Ostrava, Severomoravsky Kraj 708 52
Czechia
Not yet recruiting Martina Robenkova'
+00420597372516
martina.robenkova@fno.cz
Fakultni' Nemocnice Olomouc
Olomouc, 779 00
Czechia
Not yet recruiting Eva Rozsypalova
+420588443897
eva.rozsypalova@fnol.cz
Les Hopitaux Uiversitaires de Strasbourg
Strasbourg Cedex, Alsace 67097
France
Not yet recruiting Hélène Etienne
+33388116284
helene.etienne@chru-strasbourg.fr
Gustave Roussy
Villejuif, Ile -de-France 94800
France
Not yet recruiting Ste'phanie Lozahic
+33142114953
stephanie.lozahic@igr.fr
Institut Curie
Paris Cedex 05, Ile-de-France 75248
France
Not yet recruiting Isabelle Guillou
+33144324609
isabelle.guillou@curie.fr
Institut Clausius Re'gaud
Paris, Ile-de-France 75010
France
Not yet recruiting Iphigénie Korakis
+33531155129
korakis.iphigenie@iuct-oncopole.fr
Assistance Publique-Hopitaux de Paris Hopital Cochin
Paris, Ile-de-France 75014
France
Not yet recruiting Willana Jepiral
+33158411774
willana.jepiral@cch.aphp.fr
Hopital Foch
Suresnes, Ile-de-France 92150
France
Not yet recruiting Pascale Gendron
+33146252410
p.gendron@hopital-foch.org
Centre Le'on Be'rard
Lyon Cedex 08, Rhone-Alpes 69373
France
Not yet recruiting Emilie Chapoutier
+33426556813
emilie.chapoutier@lyon.unicancer.fr
National Cancer Center
Goyang-si, Gyeonggi-Do 10408
Korea, Republic of
Not yet recruiting Yoon-A Shin
+82319200947
75183@ncc.re.kr
The Catholic University of Korea St. Vincent's Hospital
Suwon-si, Gyeonggi-Do 16247
Korea, Republic of
Not yet recruiting Ah Jeon Yang
+82312498455
haha141@nate.com
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-Do 626-770
Korea, Republic of
Not yet recruiting Soo Ah Lee
+82553601731
90tnk@daum.net
Seoul National University Hospital
Seoul, 030380
Korea, Republic of
Not yet recruiting Boram Seo
+82220727376
seoboramcrc@gmail.com
Severance Hospital
Seoul, 03722
Korea, Republic of
Not yet recruiting SongHyun Lee
+82222276587
essong729@yuhs.ac
Asan Medical Center
Seoul, 05505
Korea, Republic of
Not yet recruiting Da Young Kim
+8223107382
dayoung.kim@amc.seoul.kr
Samsung Medical Center
Seoul, 06351
Korea, Republic of
Not yet recruiting Sena Park
+82317873949
97834@snubh.org