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BRIEF TITLE: 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

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:
  • NCT ID: NCT03980041
  • NCT Alias:
  • Sponsor: Infinity Pharmaceuticals, Inc. - Industry
  • Source: Infinity Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting July 25, 2019 Phase 2 Interventional

Primary Outcomes:

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

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

Condition:

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

Eligibility

Criteria:
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
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Samuel Agresta, MD, MPH

Role: Study Director

Affiliation: Infinity Pharmaceuticals, Inc.

Overall Contact

Name: Miriam Brody, MPH

Phone: 617-453-1142

Email: Miriam.Brody@infi.com

Link:

Location

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