A Phase 2 Study of Nab-paclitaxel and Gemcitabine With or Without Botensilimab in People With Advanced Pancreatic Cancer

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Full Title

A Randomized, Open-Label, Phase II Trial of Nab-paclitaxel + Gemcitabine with or without Botensilimab (AGEN1811) in Patients with Metastatic Pancreatic Cancer Who Have Progressed on Prior 5FU + Leucovorin + Irinotecan + Oxaliplatin (FOLFIRINOX)

Purpose

Researchers want to see if adding botensilimab to standard treatment is better than standard treatment alone for pancreatic cancer. The people in this study have pancreatic cancer that has metastasized (spread) even with prior treatment. They previously received the anti-cancer drugs 5FU, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX therapy).

Botensilimab is an immunotherapy drug. It boosts your body’s natural defenses to fight cancer. It also blocks a protein that can cause tumors to grow. If you join this study, you will be randomly assigned to get one of these treatments:

  • Botensilimab plus standard chemotherapy (nab-paclitaxel and gemcitabine)
  • Nab-paclitaxel and gemcitabine alone

All of these medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic pancreatic cancer that keeps growing even after FOLFIRINOX.
  • Have not received prior immunotherapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Eileen O’Reilly’s office at 646-888-4182.

Protocol

24-168

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05630183