CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT01174121
Title field or adapter rule: {'original_value': 'A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:22.458407+00:00
Published At: 2026-10-23T00:00:00+00:00
Record Updated At: 2026-10-23
Source Retrieved At: 2026-10-31T22:17:25.750886+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: ["Metastatic Colorectal Cancer", "Metastatic Pancreatic Cancer", "Metastatic Ovarian Cancer", "Metastatic Breast Carcinoma", "Metastatic Endocrine Tumors/ Neuroendocrine Tumors"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-23", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT01174121"
protocolSection.identificationModule.officialTitle: "A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['3/Unselected TIL + Pembro Prior to Cells', '4/Unselected TIL + Pembro at POD', '5/Unselected TIL + Pembro Prior to Cells'], 'description': 'Arm 3 or 5: Pembrolizumab 2mg/kg IV over approximately 30 minutes on Days -2, 21, 42, and 63 Arm 4: Pembrolizumab 2mg/kg IV over approximately 30 minutes (for patients who meet progressive disease per RECIST criteria and have resolved major toxicities after cell infusion or anytime during the post-treatment\n\nevaluation period; starting within 4 weeks of progression; may receive up to 8 doses every 3 weeks).', 'name': 'Pembrolizumab (Keytruda)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/CD8+ Enriched TIL (CLOSED)', '2/Unselected TIL (CLOSED)', '3/Unselected TIL + Pembro Prior to Cells', '4/Unselected TIL + Pembro at POD', '5/Unselected TIL + Pembro Prior to Cells'], 'description': 'Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.', 'name': 'Fludarabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/CD8+ Enriched TIL (CLOSED)', '2/Unselected TIL (CLOSED)', '3/Unselected TIL + Pembro Prior to Cells', '4/Unselected TIL + Pembro at POD', '5/Unselected TIL + Pembro Prior to Cells'], 'description': 'Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X2 days over 1 hr.', 'name': 'Cyclophosphamide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/CD8+ Enriched TIL (CLOSED)', '2/Unselected TIL (CLOSED)', '3/Unselected TIL + Pembro Prior to Cells', '4/Unselected TIL + Pembro at POD', '5/Unselected TIL + Pembro Prior to Cells'], 'description': 'Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses.)', 'name': 'Aldesleukin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/CD8+ Enriched TIL (CLOSED)', '2/Unselected TIL (CLOSED)', '3/Unselected TIL + Pembro Prior to Cells', '4/Unselected TIL + Pembro at POD', '5/Unselected TIL + Pembro Prior to Cells'], 'description': 'Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes (one to four days after the last dose of fludarabine).', 'name': 'Young TIL', '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

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