NCT03820921: SUCCESS

Evaluation of MMR Status and PD-L1 Expression Using Specimens Obtained by EUS-FNB in Patients With Pancreatic Cancer

Status unknown Last updated 29 January 2019

What this trial tests

trial testing EUS-FNB in Pancreatic Cancer in 30 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
1 January 2021

1 January 2022

Quick facts

Lead sponsor	Ponderas Academic Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 February 2019
Primary completion	1 January 2021
Estimated completion	1 January 2022

Drugs / interventions tested

• EUS-FNB
• Immunohistochemistry — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Ponderas Academic Hospital

Who can join

Adults 18 to 90, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pancreatic ductal adenocarcinoma (PDAC) has a suboptimal response to standard therapies that modestly impact survival due to its ability to evade host immune surveillance. Emerging evidence has shown that the co-inhibitory receptors, such as programmed death 1 (PD-1), play a critical role in cancer immune-editing. Programmed death-ligand 1 (PD-L1) is an immune checkpoint that is often activated in cancer and plays a pivotal role in the initiation and progression of cancer. The advent of immunotherapy, with checkpoint inhibitors, which block PD-L1 interaction between tumor cells and activated T cells, has significantly altered the treatment algorithm for several solid tumors.

However, the clinicopathologic significance and prognostic value of PD-L1 in PDAC remains controversial. The main technical ground may be that PDAC PD-L1 expression quantification is limited to surgical resection specimens and dependent on specific immunohistochemistry (IHC) tests. In addition, PD-L1 expression has not been extensively assessed before surgery in treatment-naive PDAC patients, due to the current IHC test requirement for a histologic rather than a cytologic evaluation. However, a recent study showed that EUS-fine needle biopsy (FNB) can successfully determine primary pancreas malignancy PD-L1 status.

One recently identified subtype within the genomic landscape of PDAC is the mismatch repair-deficient (dMMR) tumor. Evaluation of dMMR status is particularly important following the FDA approval of the PD-1 inhibitor, pembrolizumab, for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or dMMR PDAC that have progressed following prior treatment, and have no satisfactory alternative treatment options.

The objectives of the project will include the assessment of tumor PD-L1/dMMR expression in patients with PDAC using EUS-FNB samples and the prospective correlation of MMR status and PD-L1 expression with overall survival and progression-free survival of PDAC patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Match between Molecular Subtypes, Histology and Microenvironment of Pancreatic Cancer and Its Relevance for Chemoresistance.
   Martinez-Useros J, Martin-Galan M, Garcia-Foncillas J. · · 2021 · cited 22× · PMID 33477288 · DOI 10.3390/cancers13020322
2. Evaluation of MMR Status and PD-L1 Expression Using Specimens Obtained by EUS-FNB in Patients with Pancreatic Ductal Adenocarcinoma (PDAC).
   Constantin A, Iovănescu V, Cazacu IM, Ungureanu BS, et al · · 2022 · cited 2× · PMID 35204385 · DOI 10.3390/diagnostics12020294