Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
← catalyst calendarNCT05533697 · readout in 2,009 d
Sponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
361estimated
Sites
39
Countries
Australia, Germany, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-01 | actual | When the study began enrolling |
| Primary completion | 2032-02-18 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-02-18 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumors
Interventions
- Biological: mRNA-4359
- Biological: Pembrolizumab
- Biological: Ipilimumab
- Biological: Nivolumab
Primary outcomes
what the primary-completion date above is the date OFArms 1a and 1b: Maximum Tolerated Dose (MTD) or Recommended Dose for Expansion (RDE) of mRNA-4359
measured Days 1-21 (Cycle 1)
Arms 1, 2a, 2b, and 2c: Number of Participants with Dose Limiting Toxicities (DLTs)
measured Days 1-21 (Cycle 1)
Arms 1, 2a, 2b, and 2c: Number of Participants with Adverse Events (AEs), AE of Special Interest (AESIs), and Serious AEs (SAEs)
measured Up to 27 months
Arm 2d: Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
measured Day 1 up to 60 months
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