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BLADDER: Metastatic: 2nd Line: Phase 1; "D4884C00001 UBC"

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors

Title

AstraZeneca D4884C00001 UBC

Study Title

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors

Site Link

NCT02527434

Malignancy

Bladder, Second Line Metasatic Bladder Cancer

Stage

Stage 4

Disease Setting

Line Of Therapy

2nd

Investigational Agent

Tremelimumab (and Durvalumab)

Drug Class

anti CTLA-4 antibody (and anti PD-L1 antibody)

Ari VanderWalde, MD, MPH

Sponsor

AstraZeneca

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02527434

Key Eligibility Criteria Details

Metastatic urothelial bladder cancer
Failed (or intolerant to) exactly one line of prior therapy for metastatic disease, which must have contained platinum
Prior surgery, radiation,and neoadj/adj chemo are permitted
Measurable disease
No active CNS disease
No history of leptomeningeal disease
No documented autoimmune or inflammatory disorders

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Urothelial bladder cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized