Study of AGEN1884 With Pembrolizumab in 1L NSCLC

Status Terminated

Clinical Trial Summary

A Phase IIa Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with Pembrolizumab in Subjects with Chemotherapy Naïve, PD-L1 high, metastatic Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Description

This is a Phase IIa, open-label study, of AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations.

The study consists in two phases:

- Safety Run-in Phase

- Efficacy Phase

Subjects will be enrolled in a "3+3" Safety Run-in followed by enrollment completing the efficacy cohort. Two different dose levels of AGEN1884 may be tested in combination with the approved pembrolizumab treatment for this indication (until disease progression, unacceptable toxicity, or up to a maximum of 24 months). Each subject will stay on the dose level assigned at trial entry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03411473
Study type	Interventional
Source	Agenus Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	October 4, 2017
Completion date	March 1, 2019

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