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Brief Title: Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

An Open-Label, Randomized, Phase 2, Umbrella Study of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

INTRODUCTION

  • Org Study ID: INCB 24360-901
  • Secondary ID: N/A
  • NTC ID: NCT04586244
  • Sponsor: Incyte Corporation

BRIEF SUMMARY

This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

DETAILED DESCRIPTION

Participants will be stratified based on Programmed cell Death-Ligand 1 (PD-L1) Combined Positive Score ( CPS) < 10 and PD-L1 CPS ≥ 10.

  • Overall Status
    Recruiting
  • Start Date
    January 14, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Immunologic intratumoral changes

Primary Outcome 1 - Timeframe: up to 3 months

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
Histologically confirmed transitional cell urothelial carcinoma. Participants with mixed histologies are required to have a dominant (ie, 50% at least) transitional cell pattern.
Clinical stage T2-T3b, N0, M0 muscle invasive urothelial carcinoma by CT (or MRI) + Positron Emission Tomography (PET)/CT (Stage II-IIIA per American Joint Committee on Cancer (American Joint Committee on Cancer (AJCC) 2018)).
Ineligible for cisplatin therapy per modified Galsky criteria with exclusion of Eastern Cooperative Oncology Group( ECOG) PS 2 participants

- Participants who refuse cisplatin-based therapy.

- Eligible for radical cystectomy

- Residual disease after TURBT (eg, surgical opinion, cystoscopy or radiological presence).

- Eastern Cooperative Oncology Group (ECOG) Performance Status( PS) 0 or 1.

- Pretreatment tumor biopsy must be a tumor block or 20 unstained slides from biopsy of primary tumor containing at least 20% tumor.

- Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
Participation in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) before first dose.

- Previously received systemic therapy for bladder cancer or received prior treatment with checkpoint inhibitor agents (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4).

- Evidence of measurable nodal or metastatic disease.

- Concurrent anticancer therapy.

- Has had major surgery within 4 weeks before enrollment (C1D1).

- Has had known additional malignancy other than muscle-invasive Urothelial Bladder Cancer ( miUBC) that is progressing or requires active treatment, along with some protocol exceptions.

- Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg daily doses of prednisone or equivalent) or immunosuppressive drugs within 2 years of Day 1 of study treatment.

- Participants with laboratory values outside of protocol defined range.

- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent).

- Has a known active hepatitis B (HBsAg reactive) or hepatitis C or HIV,HBV, HCV or hepatitis virus coinfection.

- Participants with HIV+ disease that don't have undetectable viral load along with other protocol exceptions.

- Has known carcinomatous meningitis.

- Active infection requiring systemic antibiotics ≤ 14 days from first dose of study drug.

- Participants with known or suspected COVID-19 infection.

- Use of probiotics within 28 days from first dose of study drug.

- Current use of prohibited medication as per protocol.

- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.

- History of a gastrointestinal condition (eg, inflammatory bowel disease, Crohn's disease, ulcerative colitis) that may affect oral drug absorption.

- Participants with impaired cardiac function or clinically significant cardiac disease

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1.855.463.3463, +800 00027423

Email: medinfo@incyte.com, eumedinfo@incyte.com

LOCATION

Facility Status Contact
Facility: University of Cincinnati
Cincinnati, Ohio 45219
United States
Status: Recruiting Contact: N/A
Facility: Hospital Saint Louis
Paris Cedex 10, 75475
France
Status: Recruiting Contact: N/A
Facility: Hopital Europeen Georges Pompidou (Hegp)
Paris Cedex 15, 75015
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif, 94805
France
Status: Recruiting Contact: N/A
Facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milano, 20132
Italy
Status: Recruiting Contact: N/A