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

Overview

About this study

This study is designed to study the effect of an investigational drug, IPI-549, when given in combination with nivolumab (OPDIVO®) as compared with nivolumab alone. IPI-549 is designed to stop cancer growth by blocking PI3-kinase activity. When PI3-kinase (an enzyme that is a part of immune cells) is blocked, some immune cells may become activated and slow down tumor growth or possibly prevent it from growing. Nivolumab has been approved by the FDA to treat patients with various cancers including cancer of the urinary system (urothelial carcinoma).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:
    • With at least 1 platinum-based chemotherapy regimen for the treatment of metastatic (Stage IV) or locally advanced unresectable disease; or
    • 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 metastases.
  • 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 treatment/interpretation.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Parminder Singh, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

-

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions