West Cancer Center

ADVANCED SOLID TUMORS; Phase 1; PD-L1; \"JAVELIN\"

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications_

Title

EMD Serono 100070-001

Study Title

Site Link

NCT01772004

Malignancy

z- Advanced Solid Tumors; 1st Line Renal Cell Carcinoma only

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

1st line or later

Investigational Agent

Avelumab

Drug Class

PD-L1 inhibitor

Jason Chandler, MD

Sponsor

EMD Serono

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01772004

Key Eligibility Criteria Details

Currently open only for 1st line renal cell carcinoma

Available tissue (archival or fresh)
No prior therapy with immune checkpoint inhibitor_
No history of brain mets
No active cardiac disease
No flu-shot within 4 weeks of study

Objective

Primary- DLT; Secondary- traetment-emergent AEs, PK, irBOR, BOR, irPFS, PFS, OS, PD-L1 tumor expression, DOR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Histologically proven advanced cancer (metastatic or locally advanced)

Dosing Frequency

As per dose-escalation

Control Agents

N/A

Study Protocol

Randomized