CLINICAL_TRIALS ClinicalTrials.gov record update

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)

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT06743126
Title field or adapter rule: {'original_value': "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)", 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:29.604441+00:00
Published At: 2026-10-30T00:00:00+00:00
Record Updated At: 2026-10-30
Source Retrieved At: 2026-10-31T22:19:00.066997+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Melanoma, Cutaneous Malignant", "Mucosal Melanoma"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-30", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT06743126"
protocolSection.identificationModule.officialTitle: "A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator\u0027s Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine\u00ae IMA203-301)"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['Experimental arm'], 'description': 'one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy', 'name': 'IMA203', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'nivolumab plus relatlimab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'lifileucel', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'nivolumab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'pembrolizumab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'ipilimumab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'Dacarbazine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'temozolomide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'paclitaxel plus carboplatin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ["Control arm- investigator's choice"], 'description': 'in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC)', 'name': 'Albumin-Bound Paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

A recorded drug name is not by itself an indication or a condition-specific relationship.

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