A Phase I Study of Galunisertib and Durvalumab Immunotherapy in Patients with Metastatic Pancreatic Cancer

Full Title

H9H-MC-JBEG(b): A Phase 1b Dose-Escalation and Cohort-Expansion Study of the Safety, Tolerability, and Efficacy of a Novel Transforming Growth Factor-ß Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination with the Anti-PD-L1 Antibody Durvalumab (MEDI4736) in Recurrent or Refractory Metastatic Pancreatic Cancer

Purpose

This study is evaluating the safety and effectiveness of the investigational drugs galunisertib and durvalumab given in combination in patients with recurrent or persistent metastatic pancreatic cancer. Both drugs activate the immune system against cancer. Galunisertib also inhibits the growth of the blood vessels that tumors needs to grow and spread.

Galunisertib is taken orally (by mouth) and durvalumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic cancer that has come back or continued to grow despite no more than two prior regimens of therapy for locally advanced or metastatic disease.
  • At least 4 weeks must pass between the completion of prior therapy and entry into the study (2 weeks since radiation therapy).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anna Varghese at 646-888-4308.

Protocol

16-1410

Phase

I

Investigator

Co-Investigators

Locations