West Cancer Center

BLADDER: Metastatic: PHASE 1: PD-1 Naive: 2nd Line: \\\"PROPEL BLADDER\\\"

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

Title

Nektar 16-214-05 \\\"PROPEL BLADDER\\\"

Study Title

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

Site Link

NCT03138889

Malignancy

Bladder, Transitional Cell Carcinoma, TCC, Urothelial Carcinoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd (1st if patient refuses platinum-based therapy)

Investigational Agent

NKTR-214, atezolizumab

Drug Class

pegylated IL-2, PD-L1 inhibitor

Dan Vaena, MD

Sponsor

Nektar Therapeutics

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed locally advanced or metastatic urothelial carcinoma
ECOG PS 0-1
Measurable disease per RECIST 1.1
No prior receipt of immunotherapy with immunomodulators (eg. PD-1 inhibitors, CTLA-4 inhibitors, IDO inhibitors)
Either;
- No more than 1 prior line of platinum-containing therapy with disease progression on or following this therapy OR
- Patient refuses standard of care therapy in the 1st line
No history of or active autoimmune disease (exceptions include Hashimoto's thyroiditis, Graves' disease, TIDDM, or Med Monitor approval)

Objective

Primary- Incidence of TEAE, RP2D; Secondary-ORR, PFS, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Urothelial Carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized