A Phase 1 interventional study of RO70097890 and nab-paclitaxel in Pancreatic Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1, Interventional, and Treatment
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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 19 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
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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.
Drug: RO70097890 · Drug: nab-paclitaxel · Drug: gemcitabine
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.
Drug: RO70097890 · Drug: nab-paclitaxel · Drug: gemcitabine
Number of Adverse Events
Time frame: 2 years
Ran from Oct 2015 to primary completion in Nov 2018, 37 months.
Of 186 non-industry phase 1 interventional studies under Pancreatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 75. This study's 37 months is below that.
Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 34 and three quarters within 74.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Albumin-Bound Paclitaxel · Gemcitabine
Abramson Cancer Center at Penn Medicine →