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

• Sponsor: Baki Topal (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04156087
• Collaborator: AstraZeneca (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43.7
• Patients Per Site Per Month: 0.5

Study Details

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.

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)

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals KU Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• Baki Topal
• AstraZeneca

Investigators

• Principal Investigator: Baki Topal, MD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baki Topal, Professor, Doctor, University Hospital, Gasthuisberg
• ClinicalTrials.gov Identifier: NCT04156087
• Other Study ID Numbers: UZ S61508; 2018-002852-34
• First Posted: Nov 7, 2019
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Pancreatic Neoplasms; Gemcitabine; Durvalumab; Tremelimumab

Study Results

No Results Posted as of May 19, 2022