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

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ClinicalTrials.gov Identifier: NCT04156087
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Non-resectable Drug: Durvalumab 50 MG/ML Drug: Tremelimumab Drug: Gemcitabine Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA) Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: MIMIPAC
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
Drug: Durvalumab 50 MG/ML

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.

Other Names:
  • MEDI4736
  • IMFINZI

Drug: Tremelimumab

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.


Drug: Gemcitabine

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.

Other Name: Gemzar

Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA)
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 Measures :
  1. Progression-free survival (PFS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156087


Contacts
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Contact: Baki Topal, MD +32 16344265 baki.topal@uzleuven.be
Contact: Halit Topal, MD +32 16344265 halit.topal@uzleuven.be

Locations
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Belgium
University Hospitals KU Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Baki Topal, MD, PhD    +32 16344265    baki.topal@uzleuven.be   
Contact: Eric Van Cutsem, MD, PhD    +32 16 344418    eric.vancutsem@uzleuven.be   
Principal Investigator: Baki Topal, MD, PhD         
Sub-Investigator: Eric Van Cutsem, MD, PhD         
Sponsors and Collaborators
Baki Topal
AstraZeneca
Investigators
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Principal Investigator: Baki Topal, MD UZ Leuven
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Responsible Party: Baki Topal, Professor, Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT04156087    
Other Study ID Numbers: UZ S61508
2018-002852-34 ( EudraCT Number )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Durvalumab
Tremelimumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological