Trial Purpose

The purpose of the study was to evaluate the safety and tolerability of pepinemab in combination with avelumab and determine a recommended Phase 2 dose (RP2D) in subjects diagnosed with advanced (stage IIIB/IV) NSCLC who have either progressed on first or second-line systemic anticancer therapy, or who have declined treatment with first or second-line systemic anticancer therapy (immunotherapy naïve). The primary hypothesis being tested was whether the combination of pepinemab + avelumab is safe and may provide clinical benefit with respect to overall response rate (ORR) in patients with NSCLC.

Vaccinex’s approach is to reprogram immune suppression in the tumor microenvironment by potentially reducing the function and number of suppressive cells, such as myeloid derived.

About the Trial

This phase Ib/II study was designed to evaluate the safety, tolerability, and efficacy of pepinemab in combination with avelumab in 62 patients with advanced non-small cell lung cancer (NSCLC), including immunotherapy-naïve (ION) patients and patients whose tumors progressed following anti-PD-1/L1 monotherapy (IOF). The main objectives were to evaluate safety/tolerability, establish a recommended phase 2 dose (RP2D), obtain a preliminary evaluation of antitumor activity, and investigate candidate biomarker activity.

This study is now complete and was reported in Clinical Cancer Research.

Trial Details

Phase

Phase 1/2

Dates

Actual Study Start Date
October 5, 2017

Completion Date
September 2019

Publication Date
July 1, 2021

Sponsor

Vaccinex Inc.

Collaborators

Merck KGaA/EMD Serono

Products

pepinemab + avelumab

Age(s)

18 and Older

Condition(s)

Non-Small-Cell Lung Carcinoma

Gender(s)

All

Trial Design

 

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Shafique, M., 2021, A Phase Ib/II Study of Pepinemab in Combination with Avelumab in Advanced Non–Small Cell Lung Cancer,
Clin Cancer Res July 1 2021 (27) (13) 3630-3640; DOI: 10.1158/1078-0432.CCR-20-4792