Clinical Trial: NCT04156087 - My Cancer Genome

NCT04156087

Description:

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.

Related Conditions:

Pancreatic Adenocarcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04156087

Trial Eligibility

Document

Title

Brief Title: 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

Clinical Trial IDs

ORG STUDY ID: UZ S61508
SECONDARY ID: 2018-002852-34
NCT ID: NCT04156087

Conditions

Pancreatic Cancer Non-resectable

Interventions

Drug	Synonyms	Arms
Durvalumab 50 MG/ML	MEDI4736, IMFINZI	MIMIPAC
Tremelimumab		MIMIPAC
Gemcitabine	Gemzar	MIMIPAC

Purpose

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)

Trial Arms

Name	Type	Description	Interventions
MIMIPAC	Experimental	Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab	Durvalumab 50 MG/ML Tremelimumab Gemcitabine

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Progression-free survival (PFS)
Time Frame:	12 months
Safety Issue:
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.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Baki Topal

Last Updated

November 4, 2020

Clinical Trials /

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