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Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer (MIMIPAC)

Primary Purpose

Pancreatic Cancer Non-resectable

Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Durvalumab 50 MG/ML
Tremelimumab
Gemcitabine
Minimally Invasive Surgical Microwave Ablation (MIS-MWA)
Sponsored by
Baki Topal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Non-resectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals KU Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIMIPAC

Arm Description

Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
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

Full Information

First Posted
November 5, 2019
Last Updated
August 24, 2023
Sponsor
Baki Topal
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04156087
Brief Title
Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer
Acronym
MIMIPAC
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Baki Topal
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Non-resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIMIPAC
Arm Type
Experimental
Arm Description
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
Intervention Type
Drug
Intervention Name(s)
Durvalumab 50 MG/ML
Other Intervention Name(s)
MEDI4736, IMFINZI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Surgical Microwave Ablation (MIS-MWA)
Intervention Description
Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baki Topal, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer

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