MedTrace Logo

Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

NCT03164772 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-10-10

Study results available
· View outcomes & findings →

Summary

This is an open-label, multicenter, 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.

Arm A: messenger ribonucleic acid (mRNA) Vaccine \[BI 1361849 (formerly CV9202)\] + anti-programmed death ligand 1 (PD-L1) antibody \[durvalumab\]

Arm B: messenger ribonucleic acid (mRNA) Vaccine \[BI 1361849\] + anti-programmed death ligand 1 (PD-L1) \[durvalumab\] + anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody \[tremelimumab\]

The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).

Conditions

  • Metastatic Non-small Cell Lung Cancer
  • NSCLC

Interventions

DRUG

Durvalumab

anti-PD-L1

DRUG

Tremelimumab

anti-CTLA-4

BIOLOGICAL

BI 1361849

mRNA Vaccine

DEVICE

PharmaJet Tropis® device

The PharmaJet Tropis® device was used for the intradermal administration of the BI 1361849 vaccine components.

Sponsors & Collaborators

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • MedImmune LLC

    collaborator INDUSTRY

  • CureVac

    collaborator INDUSTRY

  • PharmaJet, Inc.

    collaborator INDUSTRY

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Jhanelle Gray, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2021-10-29
Completion
2021-10-29
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03164772 on ClinicalTrials.gov