Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abramson Cancer Center at Penn Medicine
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological documentation of primary adenocarcinoma of the pancreas
Surgically eligible for tumor resection with curative intent
Age ≥18 years
ECOG PS 0 or 1
Adequate bone marrow function (ANC ≥1,500; Hgb \>9; Plt \>100)
Adequate renal function (Cr \<1.5 ULN)
Total bilirubin ≤1.5 x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x ULN (values post biliary stenting allowed for eligibility).
Signed, written informed consent
You may not be if
Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded.
Patients with M1 disease or a history of M1 disease.
Patients with any type of recurrent pancreatic adenocarcinoma
Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer
Previous treatment with any other compound that targets CD40
Concurrent treatment with any anticancer agent outside of this protocol
Prior allogeneic bone marrow transplant
History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis,. (Vitiligo is allowed)
History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure
History of deep venous thrombosis or migratory thrombophlebitis (Trousseau);
Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer-associated DIC)
Prior allergic reactions attributed to other monoclonal antibodies
Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline
Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial
Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in-dwelling catheters
Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)
Pregnancy or breast-feeding - female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789. All female patients with reproductive potential must have a negative pregnancy test prior to enrollment. Women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method. Female patients should not become pregnant while participating in this research study or for 90 days following therapy. Male patients should not father a child while in this research study or for 90 days following therapy.
Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures
Clareo Health | Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma
