A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma

The OLYMPUS trial is a phase III multicenter trial designed to assess the efficacy and safety of treatment with MitoGel™ (mitomycin) for instillation, in the upper urinary system of patients with non-invasive low-grade, urinary tract urothelial carcinoma (UTUC). MitoGel™ is a gel formulation of mitomycin for ureteral instillation which is designed to maintain the drug over a prolonged period in the upper urinary system in order to treat low –grade UTUC.

In this study, eligible patients will receive 6 MitoGel instillations of MitoGel into upper urinary tract once per week for 6 weeks. The administration of MitoGel will be performed through a standard ureteral catheter.  If the tumor(s) disappear after 6 instillations, patients will receive up to an additional 11 (eleven) maintenance treatments.

The OLYMPUS trial is based on safety and efficacy results from a Compassionate Use Program in patients with severe, non-resectable, low-grade UTUC, demonstrating complete response (no visible disease confirmed by negative cytology) in over 60% of the evaluated patients that completed treatment, showing the potential chemoablative effects of MitoGel. In addition, these patients demonstrated lower recurrence episodes following MitoGel treatment.


Inclusion criteria (partial list):

  • Patients with upper tract urothelial carcinoma (UTUC)
  • Patients with  low grade tumor

Exclusion criteria (partial list):

  • Patient received BCG treatment during the 6 months prior to the study
  • Patient has carcinoma in situ in the past in the urinary tract.
  • Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
  • Patient has an history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
  • Patient is being treated with systemic chemotherapy

Medical centers in USA and Israel have opened the OLYMPUS study for patient enrollment.


Alaska Urological Institute
Anchorage, Alaska, United States, 99503
Contact: Josh Logan, MD    907-276-1455    Joshuaelogan@gmail.com

Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Contact: Mitchell Humphreys, M.D.    480-342-2951    humphreys.mitchell@mayo.edu
Contact: Cher-yee Lye    480-342-6012    Lye.Cher-Yee@mayo.edu

University of California
Davis, California, United States, 95616
Contact: Marc Dall’Era, MD    916-734-2893    mdallera@ucdavis.edu

Loma Linda Cancer Center
Loma Linda, California, United States, 92354
Contact: Brian Hu, M.D.       BHu@llu.edu
Contact: Arielle Dennis    909-558-4050    ardennis@llu.edu

University of California
Los Angeles, California, United States, 90095
Contact: Karim Chamie, MD    310-206-8183    kchamie@mednet.ucla.edu

Providence Medical Institute
Santa Monica, California, United States, 90404
Contact: Jennifer Linehan, M.D.       Jennifer.Linehan@providence.org
Contact: Dorreth King-Rucker    (310) 582-7138    Dorreth.King-Rucker@providence.org

Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Contact: Raymond Pak, M.D.    404-683-5298    Pak.Raymond@mayo.edu
Contact: Katie Custer       Custer.Kaitlynn@mayo.edu

Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Contact: Hristos Kaimakliotis, M.D.       hkaimakl@iupui.edu
Contact: Courtney Dhondt    317.274.1791    cgerler@iu.edu

University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Mike O’Donnell, M.D.       michael-odonnell@uiowa.edu
Contact: Janelle Born    319-356-4797    Janelle-born@uiowa.edu

John Hopkins University
Baltimore, Maryland, United States, 21218
Contact: Phillip Pierorazio, MD    410-955-6850    philpierorazio@jhmi.edu

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Contact: Alon Weizer, M.D.       aweizer@umich.edu
Contact       bksmith@umich.edu

University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Weight, M.D.    734-232-0061    cjweight@umn.edu
Contact: Therese Perrier    612-625-3319    perri084@umn.edu

Mayo Clinic health system
Rochester, Minnesota, United States, 55905
Contact: Lance Mynderse, M.D.    507-284-2297    Mynderse.lance@mayo.edu
Contact: Tessa Kroeninger    507-284-1724    Kroeninger.Tessa@mayo.edu

Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, New York, United States, 10032-3784
Contact: Ojas Shah, M.D.       os2302@cumc.columbia.edu
Contact: Anna Rodriguez    212-305-1371    ar2442@cumc.columbia.edu

Weill Cornell Medical Center
New York, New York, United States, 10065
Contact: Douglas S Scherr, MD    212-746-5788    dss2001@med.cornell.edu

Montefiore Medical Center (Albert Einstein)
The Bronx, New York, United States, 10467
Contact: Joshua Stern, MD    347-842-1715    jstern@montefiore.org

University of north carolina – Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Contact: Michael Woods, MD    919-537-3505    Michael_woods@med.unc.edu

Duke University
Durham, North Carolina, United States, 27708
Contact: Brant Inman, M.D.    919-684-1322    brant.inman@duke.edu
Contact: Mary Motta    919-681-3675    mary.motta@duke.edu

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Andrew Stephenson, M.D.    216-444-0124    stephea2@cccf.org
Contact: Joanna Homann    (216) 444-0124    HOMANNJ@ccf.org

The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Contact: Ahmad Shabsigh, MD    614-293-7833    ahmad.shabsigh@osumc.edu

Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Contact: Jay Raman, M.D.    717-531-6979    jraman@hmc.psu.edu
Contact: Kathleen Lehman    (717) 531-5930    Klehman3@pennstatehealth.psu.edu

Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Contact: Scott Hubosky, M.D.    215-955-1000    scott.hubosky@jefferson.edu
Contact: Katherine Burns    (215) 520-0189    katherine.Burns@jefferson.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jefferey Gingrich, MD    412-605-3015    gingrichjr@upmc.edu

MD Anderson
Houston, Texas, United States, 77006
Contact: Surena Matin, MD    713-792-3250    surmatin@mdanderson.org

Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Guilherme Godoy, MD    713-798-7296    godoy@bcm.edu

Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Contact: Michael Williams, M.D.       MichaelWilliams@urologyofva.net
Contact: Michele Schindler    (757) 452-3465    mschindler@urologyofva.net

Sheba Medical Center, Israel
Ramat Gan, Israel, 52621
Contact: Nir Kleinmann, M.D.    952-53-3398845    nir.kleinmann@gmail.com
Contact: Dafna Ben-Yaacov, Phd    972-3-5307363    Dafna.BenYaacov@sheba.health.gov.il

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