Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT05533697
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • mRNA-4359 — BIOLOGICAL
    Intramuscular Injection
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion
  • Ipilimumab — BIOLOGICAL
    Intravenous infusion
  • Nivolumab — BIOLOGICAL
    Intravenous infusion

Study Details

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.

Key Dates

Start date
Sep 1, 2022
Status verified
May 2026
Primary completion
Feb 18, 2032
Completion
Feb 18, 2032

Study Design

Enrollment
361 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1a (Dose Escalation): mRNA-4359 Alone
    Adult participants with locally advanced or metastatic cancer will be administered mRNA-4359 at an applicable dose as monotherapy.
  • Experimental: Arm 1b (Dose Confirmation): mRNA-4359 in Combination with Pembrolizumab
    Participants with locally advanced or metastatic, and checkpoint inhibitor (CPI) refractory melanoma or locally advanced or metastatic, and CPI refractory non-small-cell lung carcinoma (NSCLC) will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: Arm 1b (Melanoma Expansion Cohort): mRNA-4359 in Combination With Pembrolizumab
    Participants 18 years or older with CPI refractory, advanced/metastatic melanoma with a programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥1% who have had progression on at least 1 prior CPI-based systemic therapy in the advanced/metastatic disease setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: Arm 2a (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab
    Adult participants with locally advanced or metastatic melanoma who have not yet received any prior systemic therapy for their melanoma in this setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: Arm 2b (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab
    Adult participants with locally advanced or metastatic NSCLC with a PD-L1 TPS of ≥50%, with no known epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive tumor mutations who have not yet received any prior systemic therapy for their NSCLC will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: Arm 2c (Dose Expansion): mRNA-4359 in Combination with Ipilimumab and Nivolumab
    Adult participants with locally advanced or metastatic melanoma who have not yet received any prior systemic therapy in this setting will be administered mRNA-4359 at an applicable dose in combination with ipilimumab and nivolumab.
  • Experimental: Arm 2d (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab
    Participants 12 years or older with CPI refractory, advanced/metastatic melanoma with a PD-L1 TPS of ≥1% who have had progression on at least 1 prior CPI-based systemic therapy in the advanced/metastatic disease setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: Pharmacodynamic (PD) Arm (Group 1): mRNA-4359 in Combination with Pembrolizumab
    Participants with locally advanced or metastatic, and CPI refractory melanoma will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.
  • Experimental: PD Arm (Group 2): mRNA-4359 in Combination with Pembrolizumab
    Participants with locally advanced or metastatic, and CPI refractory NSCLC with a PD-L1 TPS ≥1% will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab.

Primary Outcome Measure

Arms 1a and 1b: Maximum Tolerated Dose (MTD) or Recommended Dose for Expansion (RDE) of mRNA-4359 [ Time Frame: Days 1-21 (Cycle 1) ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94143-
University of Colorado Cancer CenterAuroraColorado80045-
George Washington UniversityWashington D.C.District of Columbia20037-
Orlando Health UF Health Cancer CenterOrlandoFlorida32806-
The University of Chicago MedicineChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-
Washington UniversitySt LouisMissouri63110-
John Theurer Cancer CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer Center - Melanoma & ImmunotherapeuticsNew YorkNew York10065-
NYU Langone Health-Perlmutter Cancer CenterNew YorkNew York10016-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Oregon Health & Science UniversityPortlandOregon97239-
Sara Cannon Research Institute TennesseeNashvilleTennessee37203-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, COGeorge Washington University· Washington D.C., DCOrlando Health UF Health Cancer Center· Orlando, FLThe University of Chicago Medicine· Chicago, IL

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