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

Baki Topal

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer Non-resectable

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04156087

UZ S61508

2018-002852-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

MIMIPAC

Experimental group

Description:

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

Treatment:

Procedure: Minimally Invasive Surgical Microwave Ablation (MIS-MWA)

Drug: Tremelimumab

Drug: Gemcitabine

Drug: Durvalumab 50 MG/ML