Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lei Zheng
With
Merck Sharp & Dohme LLC
Verastem, Inc.
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years.
Has pancreatic ductal adenocarcinoma
Has resectable disease at the time of diagnosis
Has not received any systemic therapy for pancreatic ductal adenocarcinoma
Has stage ≤ IIb disease at time of diagnosis and enrollment
Elevated tumor marker, CA (carbohydrate antigen) 19-9 \>200
ECOG performance status 0 or 1
Patient must have adequate organ function defined by the study-specified laboratory tests.
Must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.
You may not be if
Patients who have received any prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer.
Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received prior therapy with FAK inhibitor.
Woman who are pregnant or breastfeeding.
Have received a live vaccine or live-attenuated vaccine within 30 days prior to study drug.
Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
History or current use of immunosuppressive medications within 7 days prior to study medications.
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has a history of (non-infectious) pneumonitis/interstitial lung disease or current pneumonitis.
Has an active infection requiring systemic therapy.
Infection with HIV or hepatitis B or C.
Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known allergy or hypersensitivity to the study drugs.
Received any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
Has history of any organ transplant, including corneal transplants.
Clareo Health | Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma
