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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | Arm I provides one dose of RO70097890 as a single agent in the neoadjuvant setting. Patients will recover from any toxicities and will then have their disease surgically resected. After recovery from surgery patients will proceed to adjuvant therapy which will include nab-paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on days 1,8 and 15 of a 28 day cycle along with RO7009789 0.2mg/kg on day 3 of each cycle. Four cycles of adjuvant therapy will be given. All medications are administered intravenously. |
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| Arm2 | Experimental | Arm II provides one dose of RO7009789 two days after one dose of nab-paclitaxel and one dose of gemcitabine prior to surgery. Nab-paclitaxel and gemcitabine are given on day 1. RO7009789 will be given on day 3. Patients will recover from any toxicities and will then have their disease surgically resected. Patients will receive four cycles of these same medications in an adjuvant fashion after recovering from surgical resection. A cycle will consist of nab-paclitaxel (125mg/m²), gemcitabine (1000mg/m²) given on days 1,8 and 15 of a 28 day cycle along with RO7009789 0.2mg/kg on day 3 of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO70097890 | Drug |
| ||
| nab-paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Vonderheide, MD, DPhil | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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|
| gemcitabine | Drug |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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