The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin Spieler
About this trial
The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
Microsatellite stable (MSS) disease by pathologic assessment.
Patients must have measurable disease as defined by RECIST 1.1.
Disqualifiers
Liver tumor burden exceeding 25% of total liver volume.
Active, untreated central nervous system (CNS) metastases.
Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Body Radiation Therapy
RadiationThe 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. Radiation therapy must be completed for up to 10 daily treatments within a 15-day course.
Botensilimab
DrugParticipants 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.
Balstilimab
DrugParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Radiation, Botensilimab Combined with Balstilimab Treatment GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Clinical Benefit Rate (CBR)
The Clinical Benefit Rate (CBR) among participants will be reported. CBR is the number of participants achieving complete response (CR), partial response (PR) or stable disease after start of study therapy. Response will be assessed using Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria.
Time frame
Up to 15 monthsSecondary outcomes
1
Objective Response Rate (ORR)
Objective response rate will be reported, based on best response according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria. Objective response (OR) is defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) to study therapy.
Time frame
Up to 15 months2
Progression-Free Survival (PFS)
Progression-free survival (PFS) among participants will be reported. PFS is defined as the elapsed time in months since the start of radiation therapy until the first documentation of disease progression or death.
Time frame
Up to 5 years3
Overall Survival (OS)
Overall survival (OS) among participants will be reported. OS is defined as the elapsed time in months from the start of radiation therapy until death by any cause.
Time frame
Up to 5 years4
Number of Participants Experiencing Grade 3 or Higher Toxicities
The number of participants experiencing Grade 3 or higher toxicities will be reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov