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Brief Title: Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

A Phase 2, Multicenter, Randomized, Double-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination With IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients With Immune Therapy-Naïve, Advanced Urothelial Carcinoma


  • Org Study ID: IPI-549-02
  • Secondary ID: N/A
  • NTC ID: NCT03980041
  • Sponsor: Infinity Pharmaceuticals, Inc.


The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab
when compared to nivolumab monotherapy in advanced urothelial cancer patients.


Study IPI-549-02 is a multi-national, prospective, randomized, active-control Phase II trial
to evaluate the efficacy and safety of IPI 549 administered in combination with nivolumab
compared to nivolumab monotherapy.

The study will enroll approximately 160 checkpoint-naïve, advanced urothelial cancer patients
who have progressed or recurred following treatment with platinum-based chemotherapy.
Patients will be randomized 2:1 to receive intravenous (IV) nivolumab 480 mg every 4 weeks
(Q4W) in combination with oral (PO) IPI 549 40 mg once daily (QD) or IV nivolumab 480 mg Q4W
in combination with placebo PO QD.

Eligible patients who have confirmed progression of disease during treatment with nivolumab
monotherapy may crossover to the combination treatment arm.

  • Overall Status
  • Start Date
    September 25, 2019
  • Phase
    Phase 2
  • Study Type


Primary Outcome 1 - Measure: Objective Response Rate (ORR) per RECISTv1.1

Primary Outcome 1 - Timeframe: First dosing date to date of confirmed disease progression, assessed up to 24 months


  • Bladder Cancer
  • Urothelial Carcinoma
  • Solid Tumor
  • Advanced Cancer


Inclusion Criteria:

- Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis,
ureter, bladder, or urethra

- Measurable disease by CT or MRI as defined by RECIST v1.1

- Disease progression or recurrence after treatment:

- i) With at least 1 platinum-based chemotherapy regimen for the treatment of metastatic
(Stage IV) or locally advanced unresectable disease; or

- ii) With disease recurrence within 1 year of completing a platinum-based neoadjuvant
or adjuvant therapy

- Subject that have received more than 2 prior lines of chemotherapy must not have liver

- Tumor tissues (archived or new biopsy) must be provided for biomarker analysis

- Eastern Cooperative Oncology Group (ECOG) performance status ≤1

- Blood sample must be provided for mMDSC levels for randomization into the study

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Any serious or uncontrolled medical disorder that may interfere with study

- Prior malignancy active within the previous 3 years except for local or organ confined
early stage cancer that has been apparently cured

- Active, known, or suspected autoimmune disease

- A condition requiring systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalents) or other immunosuppressive medications within 14 day of study
drug administration

- Prior therapy with anti-tumor vaccines, any T cell co-stimulation or checkpoint
pathways, or IPI-549

- Prior surgery or gastrointestinal dysfunction that may affect drug absorption

- Past medical history of interstitial lung disease

- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control

- Positive test for hepatitis B, C or HIV

- Dependent on continuous supplemental oxygen

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No


Name: Halle Zhang, PhD, RN

Role: Study Director

Affiliation: Infinity Pharmaceuticals, Inc.

Overall Contact

Name: Halle Zhang, PhD, RN

Phone: 617-453-1142

Email: Miriam.Brody@infi.com


Facility Status Contact
Facility: Parkview Physicians
Fort Wayne, Indiana 46845
United States
Status: Recruiting Contact:
Zhentao Zhang, MD

Facility: University of MD - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
Status: Recruiting Contact:
Arif Hussain, MD

Facility: Karmanos Cancer Center
Detroit, Michigan 48201
United States
Status: Recruiting Contact:
Elizabeth Heath, MD

Facility: Coborn Cancer Center
Saint Cloud, Minnesota 56303
United States
Status: Recruiting Contact:
Donald Jurgens, MD

Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact:
Benjamin Gartrell, MD

Facility: Bon Secours St. Francis Cancer Center
Greenville, South Carolina 29607
United States
Status: Recruiting Contact:
Stephen Dyar, MD

Facility: Sarah Cannon Tennessee Oncology
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Meredith McKean, MD

Facility: Onkologicka Klinika
Praha, 140 59
Status: Recruiting Contact:
Tomas Buchler, MD

Facility: Centre Oscar Lambret
Lille, 59020
Status: Recruiting Contact:
Aurélien Carnot, MD

Facility: Institut Paoli-Calmettes
Marseille, 13009
Status: Recruiting Contact:
Gwenaëlle Gravis, MD

Facility: Centre Antoine Lacassagne
Nice, 06189
Status: Recruiting Contact:
Delphine Borchiellini, MD

Facility: CHU de Strasbourg
Strasbourg, 67000
Status: Recruiting Contact:
Philippe Barthelemy, MD

Facility: Institut Claudius Regaud
Toulouse, 31300
Status: Recruiting Contact:
Damien Pouessel, MD

Facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)
Candiolo, 10060
Status: Recruiting Contact:
Massimo Aglietta, MD

Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47104
Status: Recruiting Contact:
Ugo De Giorgi, MD

Facility: Istituto Nazionale dei Tumori
Napoli, 80131
Status: Recruiting Contact:
Rosa Tambaro, MD

Facility: Dzienny Oddzial Chemioterapii
Racibórz, 47-400
Status: Recruiting Contact:
Hanslik Jerzy, MD

Facility: EXAMEN sp
Skorzewo, 60-185
Status: Recruiting Contact:
Piotr Tomczak, MD

Facility: Oddzial Chorob Rozrostowych Wojewodzki Szpital
Łódź, 93-153
Status: Recruiting Contact:
Malgorzata Ulanska, MD

Facility: Clinical Centre of Serbia
Belgrade, 11 000
Status: Recruiting Contact:
Aleksandar Janicic, MD

Facility: Institute for Oncology of Vojvodina
Sremska Kamenica, 21 204
Status: Recruiting Contact:
Lazar Popovic, MD

Facility: ICO Institute Catalan of Oncology
Barcelona, 08907
Status: Recruiting Contact:
Xavier Garcia del Muro, MD

Facility: Hospital de Sant Creu i Sant Pau
Barcelona, 8005
Status: Recruiting Contact:
Jose Pablo Maroto, MD

Facility: IMQ Zorrotzaurre
Bilbao, 48180
Status: Recruiting Contact:
Ricardo Fernandez Rodriguez, MD

Facility: MD Anderson Cancer Center Madrid
Madrid, 28033
Status: Recruiting Contact:
Enrique Grande, MD

Facility: Hospital Ramón y Cajal
Madrid, 28034
Status: Recruiting Contact:
Pablo Gajate, MD

Facility: Hospital Universitatio HM Sanchinarro
Madrid, 28050
Status: Recruiting Contact:
Elena Sevillano Fernandez, MD

Facility: Hospital Universitario Central de Asturias
Oviedo, 33011
Status: Recruiting Contact:
Pilar Solis Hernandez, MD

Facility: Hospital Universitario
Sevilla, 41013
Status: Recruiting Contact:
Begoña Perez Valderrama, MD