A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vsStandard of Care in Participants With Bladder Cancer That HasInvaded Into the Muscle Wall of the Bladder

Phase 1

• Conditions: Muscle-Invasive Bladder Cancer; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002676-40-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-08
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

- MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
- Must be deemed eligible for RC by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status
0 or 1
- Cisplatin-ineligible participants will be defined by any one of the
following criteria:
i) Impaired renal function (glomerular filtration rate [GFR] = 30 but
< 60 mL/min)
ii) GFR should be assessed by direct measurement (ie, creatinine
clearance) or, if not available, by calculation from serum/plasma
creatinine (Cockcroft-Gault formula)
iii) Common Terminology Criteria for Adverse Events (CTCAE)
version 5, = Grade 2 hearing loss (assessed per local SOC).
iv) CTCAE version 5, = Grade 2 peripheral neuropathy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 504

Exclusion Criteria

- Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted.
Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is
permitted if completed at least 6 weeks prior to initiating study treatment.
- Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC or urothelial carcinoma not confined to the bladder.
Other protocol defined inclusion/exclusion criteria could apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified