Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer Non-resectable
- Interventions
- Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA)
- Registration Number
- NCT04156087
- Lead Sponsor
- Baki Topal
- Brief Summary
This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.
- Detailed Description
Research Hypothesis Does MIS-MWA combined with durvalumab (MEDI4736) plus tremelimumab and gemcitabine prolong progression-free survival in patients with unresectable non-metastatic adenocarcinoma of the pancreas?
Investigational Product(s) and Reference Therapy:
Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.
Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.
Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest.
Objectives:
Primary Objectives:
Progression-free survival (PFS)
Secondary Objectives:
* Safety: clinical and hematological toxicity (NCI CTCAE v. 5.0) of chemotherapy and immunotherapy
* Safety: number and type of postoperative complications of the MIS-MWA procedure
* Length of hospital stay
Tertiary Objectives Overall survival (OS)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017
- Histologically proven adenocarcinoma of the pancreas located in the head, body or tail
- LAPC tumor greatest diameter maximum 5 cm
- Male or female, age 18 years and older, ECOG PS 0-1
- Life expectancy of at least 12 weeks
- Only patients who did not receive chemotherapy for their PC are allowed
- Patients without distant organ metastases on conventional diagnostic imaging
- Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients
- Patients fit for MIS-MWA
- Able to receive Durvalumab and Tremelimumab.
- Patients with good liver and renal function and with good hematology
- Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
- Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations
- Pregnancy
- Metastatic PC on conventional diagnostic imaging or staging laparoscopy
- LAPC tumor greatest diameter is larger than 5 cm
- Borderline or resectable PC defined according to the NCCN guidelines version 2.2017
- Systemic chemo(radio)therapy is not allowed before MIS-MWA
- Major surgical procedure within 28 days prior to the first dose of investigational products
- Classic contraindications for PDL and CTLA antibodies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MIMIPAC Durvalumab 50 MG/ML Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab MIMIPAC Minimally Invasive Surgical Microwave Ablation (MIS-MWA) Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab MIMIPAC Tremelimumab Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab MIMIPAC Gemcitabine Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 12 months The study is exploratory and cannot be statistically powered for comparisons. Median progression-free survival (PFS) time is chosen as the clinically meaningful outcome. Survival estimates will be calculated using the Kaplan-Meier method. For information, the reference PFS time in patients with non-metastatic LAPC treated with gemcitabine monotherapy is about 6 months. Results will be presented descriptively.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals KU Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium