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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Ludwig Institute for Cancer Research
Study ID
NCT03164772
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Non-small Cell Lung Cancer
  • NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    anti-PD-L1
  • Tremelimumab — DRUG
    anti-CTLA-4
  • BI 1361849 — BIOLOGICAL
    mRNA Vaccine
  • PharmaJet Tropis® device — DEVICE
    The PharmaJet Tropis® device was used for the intradermal administration of the BI 1361849 vaccine components.

Study Details

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).

Key Dates

Start date
Dec 20, 2017
Status verified
Oct 2022
Primary completion
Oct 29, 2021
Completion
Oct 29, 2021

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: BI 1361849 mRNA Vaccine + durvalumab
    The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; BI 1361849 was to be administered as 14 doses over the 12 cycles.
  • Experimental: Arm B: BI 1361849 mRNA Vaccine + durvalumab + tremelimumab
    The BI 1361849 mRNA vaccine comprises 6 drug product components (F2408 coding for MUC1, F2409 coding for survivin, F2410 coding for NY-ESO-1, F2624 coding for 5T4, F2625 coding for MAGE-C2, and F2626 coding for MAGE-C1), which were provided and administered separately; each component was administered twice, thus there were 12 intradermal administrations of 100 µL (80 µg) each for each dose. The PharmaJet Tropis® device was used for the administration of the BI 1361849 components. Durvalumab 1500 mg was to be administered as an intravenous (IV) infusion every 4 weeks for 12 cycles; tremelimumab 75 mg was to be administered as an intravenous (IV) infusion every 4 weeks for the first 4 cycles (Arm B only); BI 1361849 was to be administered as 14 doses over the 12 cycles.

Primary Outcome Measure

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: up to 15 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research FacilityGilbertArizona85234-
Research FacilityTampaFlorida33612-
Research FacilityDetroitMichigan48201-
Research FacilityNew YorkNew York10016-
Research FacilityMilwaukeeWisconsin53226-

Find similar trials in Gilbert, AZ

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