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

NCT04156087 | Completed Phase 2 FDA Drug

• 2 other identifiers: UZ S615082018-002852-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Non-resectable

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

MIMIPAC

EXPERIMENTAL

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

Drug: Durvalumab 50 MG/ML; Drug: Tremelimumab; Drug: Gemcitabine; Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA)

Interventions

Durvalumab 50 MG/ML DRUG

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.

Also known as: MEDI4736, IMFINZI

MIMIPAC

Tremelimumab DRUG

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.

MIMIPAC

Gemcitabine DRUG

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.

Also known as: Gemzar

MIMIPAC

Minimally Invasive Surgical Microwave Ablation (MIS-MWA) PROCEDURE

Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab

MIMIPAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baki Topal: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospitals KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

durvalumab; tremelimumab; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Baki Topal, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: May 9, 2020
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)