Clinical trial · Interventional
Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer
Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial
NCT04156087CI-TRIAL-00080512MIMIPACcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab 50 MG/ML | Drug | Durvalumab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Minimally Invasive Surgical Microwave Ablation (MIS-MWA) | Procedure | — | UNRESOLVED |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MIMIPAC
- description
- Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
- interventionNames
- Drug: Durvalumab 50 MG/ML
- Drug: Tremelimumab
- Drug: Gemcitabine
- Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA)
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.