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VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer

NCT03268057 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-05-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small cell lung cancer. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

VX15/2503 + avelumab

Dose escalation will begin at 5 mg/kg of VX15/2503 and will increase up to 20 mg/kg with a constant dose of avelumab at 10 mg/kg. A recommended phase II dose of VX15/2503 will be determined and then utilized in the expansion phase with 10 mg/kg of avelumab.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Vaccinex Inc.

    lead INDUSTRY

Principal Investigators

  • John E Leonard, PhD · Vaccinex Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2020-09-09
Completion
2020-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03268057 on ClinicalTrials.gov