West Cancer Center

BLADDER; Metastatic; 2nd-line; PD-1 inh; "KEYNOTE-045"

A phase III randomized clinical trial of pembrolizumab (MK-3475) versus paclitaxel, docetaxel, or vinflunine in subjects with recurrent or progressive metastatic urothelial cancer

Title

Merck MK-3475-045

Study Title

A phase III randomized clinical trial of pembrolizumab (MK-3475) versus paclitaxel, docetaxel, or vinflunine in subjects with recurrent or progressive metastatic urothelial cancer

Site Link

NCT02256436

Malignancy

Bladder cancer, urothelial carcinoma, renal pelvis, ureter, urethra

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

2nd line

Investigational Agent

Pembrolizumab (MK-3475)

Drug Class

PD-1 inhibitor

Brad Somer, MD

Sponsor

Merck Sharp & Dohme Corp.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02256436

Key Eligibility Criteria Details

Predominantly transitional cell urothelial carcinoma of bladder, renal pelvis, ureter, or urethra
Recurred or progressed following platinum-based chemotherapy

Measurable disease
No more than 2 prior lines of systemic�therapy (including adjuvant)
Willing to provide tissue (archived if available, new bx otherwise)
ECOG PS 0-2
No CNS mets
No active autoimmune disease
No active cardiac disease
No interstitial lung dz or non-infectious PNA
No HIV, HBV, or HCV

Objective

Primary: OS; Secondary- ORR, PFS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

transitional cell or mixed transitional/non-transitional with predominant transitional component

Dosing Frequency

Pembrolizumab 200mg IV q3weeks

Control Agents

Docetaxel 75mg/m2 OR paclitaxel 175mg/m2 OR vinflunine 320mg/m2 IV q3 weeks (MD choice)

Study Protocol

Randomized

Yes