NCT03164772

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

A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This was a Phase 1/2, 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 in subjects with NSCLC. Up to 56 subjects were planned for enrollment from up to 8 clinical sites in 2 arms: Arm A: mRNA Vaccine \[BI 1361849 (formerly CV9202)\] + anti-PD-L1 antibody \[durvalumab\] Arm B: mRNA Vaccine \[BI 1361849\] + anti-PD-L1 \[durvalumab\] + anti-CTLA-4 antibody \[tremelimumab\] Subjects must have had histologically confirmed metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1 mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of anti-PD-1/PD-L1 therapy and must not have had progression at or before 12 weeks after start of the prior anti-PD-1/PD-L1 treatment.

Conditions

• Metastatic Non-small Cell Lung Cancer
• NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-20
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2017-05-24
• Last updated: 2022-10-10
• Results posted: 2022-09-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study