A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

Inclusion criteria

• . Have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma based on pathology report
• . Have received at least one prior regimen of therapy for metastatic disease. May have received an unlimited number of treatments in the neoadjuvant or adjuvant setting prior to the appearance of metastatic disease.
• . Be willing and able to provide written informed consent for the trial.
• . Be 18 years of age on day of signing informed consent.
• . Have measurable disease based on RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• . Have documented objective radiographic progression on or after stopping treatment with first-line therapy.
• . Be willing to provide tissue from a newly obtained core- or excisional biopsy of a tumor lesion from a metastatic site. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Patients for whom newly-obtained samples cannot be provided (e.g. inaccessible or patient-safety concern) may submit an archived specimen only upon agreement from Merck. The specimen must be from a biopsy site that would be accessible for at least one subsequent biopsy after initiation on the trial.
• . Has the ability to swallow and retain oral medication.

Exclusion criteria