Clinical trial NCT04156087: Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer
Official title: Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer Non-resectable
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-11-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals KU Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Baki Topal, MD
role: PRINCIPAL_INVESTIGATOR
References: