A PHASE II RANDOMIZED, OPEN-LABEL, TRIAL OF NAB-PACLITAXEL + GEMCITABINE WITH OR WITHOUT BOTENSILIMAB (AGEN1181) IN PATIENTS WITH METASTATIC PANCREATIC CANCER WHO HAVE PROGRESSED ON PRIOR 5FU + LEUCOVORIN + IRINOTECAN + OXALIPLATIN (FOLFIRINOX)

Contact:

NCT Number:

Protocol:

AAAV2332

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

The purpose of this study is to find out if study drug, botensilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine, can help patients with metastatic pancreatic cancer. Botensilimab has not been approved by US Food and Drug Administration (FDA). Nab-paclitaxel + gemcitabine is an approved chemotherapy combination for pancreatic cancer, but they are not FDA approved to treat pancreatic cancer that has progressed after receiving initial treatment. This trial consists of two parts (Part 1 and Part 2). All visits and procedures are the same in both parts of the study however the study treatments and intent of the study are different in each part. Part 2 will not begin until Part

Are you Eligible? (Inclusion Criteria)

  • ≥ 18 years of age. 2. Voluntarily agree to participate by giving signed, dated, and written informed consent form prior to any study-specific procedures. 3. Cellularly confirmed diagnosis of pancreatic ductal adenocarcinoma. 4. Must have had disease progression on any version of FOLFIRINOX for metastatic disease 5. Life expectancy of at least 3 months.

Specialty Area(s)

Pancreatic Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Gastrointestinal Oncology
  • Director of Pancreas Translational Research
  • Co-Director of The Pancreas Center

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032