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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT03070392
Title field or adapter rule
{'original_value': 'A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:29.650420+00:00
Published At
2021-09-14T00:00:00+00:00
Record Updated At
2026-10-29
Results Posted At
2021-09-14
Source Retrieved At
2026-10-31T22:18:13.198083+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
["Uveal Melanoma"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-29", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT03070392"
protocolSection.identificationModule.officialTitle
"A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma"
protocolSection.statusModule.overallStatus
"COMPLETED"
protocolSection.designModule.phases
["PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
{"date": "2021-09-14", "type": "ACTUAL"}

Study condition terms

  • Uveal Melanoma (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['IMCgp100 (tebentafusp, Kimmtrak)'], 'description': 'IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity', 'name': 'IMCgp100', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ["Investigator's Choice"], 'description': 'Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity', 'name': 'Dacarbazine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ["Investigator's Choice"], 'description': 'Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments', 'name': 'Ipilimumab', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ["Investigator's Choice"], 'description': 'Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity', 'name': 'Pembrolizumab', 'type': 'BIOLOGICAL'} (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

  • Dacarbazine (protocolSection.armsInterventionsModule.interventions[].name)

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

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