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



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:October 2015
End Date:October 2018
Contact:Robert Vonderheide, MD,DPhil
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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Phase I 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

The main purpose of this study is to learn if adding the investigational drug RO7009789
(anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe,
feasible, and beneficial to patients with pancreatic cancer. This study also intends to look
at blood and tissue samples to help doctors better understand the role of the immune system
in fighting cancer.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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