A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06843551

Title field or adapter rule

{'original_value': 'A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:27.130394+00:00

Published At

2026-08-21T00:00:00+00:00

Record Updated At

2026-08-21

Source Retrieved At

2026-10-31T22:17:58.991924+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 Pancreatic Ductal Adenocarcinoma", "Metastatic Pancreatic Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-08-21", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06843551"

protocolSection.identificationModule.officialTitle

"A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Metastatic Pancreatic Ductal Adenocarcinoma (protocolSection.conditionsModule.conditions)
• Metastatic Pancreatic Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Radiation, Botensilimab Combined with Balstilimab Treatment Group'], 'description': 'The radiation therapy (RT) prescription biologically effective dose (BED10) goal for tumor (α/β=10) aims to achieve at least BED10= 60 Gy for a single fraction plan and at least BED10=100 Gy for a multi-fraction plan. This equates to a prescription dose of at least 20 Gy in a single fraction, 42 Gy over 3 fractions, 50 Gy over 5 fractions, and 62 Gy over 10 fractions.\n\nRadiation therapy must be completed for up to 10 daily treatments within a 15-day course.', 'name': 'Stereotactic Body Radiation Therapy', 'type': 'RADIATION'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Radiation, Botensilimab Combined with Balstilimab Treatment Group'], 'description': 'Participants will be receive 75mg of Botensilimab immunotherapy administered via intravenous infusion, every six weeks for up to 4 doses, about 24 weeks. Botensilimab therapy will begin no later than seven (7) days after completion of radiation therapy.', 'name': 'Botensilimab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Radiation, Botensilimab Combined with Balstilimab Treatment Group'], 'description': 'Participants will receive 240mg of Balstilimab immunotherapy, administered via intravenous infusion, every 2 weeks for up to one (1) year. Balstilimab therapy will begin no later than seven (7) days after completion of radiation therapy.', 'name': 'Balstilimab', '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

• Botensilimab (protocolSection.armsInterventionsModule.interventions[].name)
• Balstilimab (protocolSection.armsInterventionsModule.interventions[].name)

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

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