A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma (ACTengine® IMA203-301)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517062-42-00

Acronym

IMA203-301

Enrollment

Registered

2025-04-16

Start date

2025-05-02

Completion date

Unknown

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma, cutaneous malignant

Brief summary

Progression-free survival (PFS), centrally assessed by a Blinded Independent Central Review (BICR) using RECIST 1.1

Interventions

DRUGOpdualag 240 mg/80 mg concentrate for solution for infusion

DRUGIPILIMUMAB

DRUGDACARBAZINE

DRUGNIVOLUMAB

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGPEMBROLIZUMAB

DRUGTEMOZOLOMIDE

DRUGCARBOPLATIN

DRUGIMA203

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS), centrally assessed by a Blinded Independent Central Review (BICR) using RECIST 1.1	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026