MEDI9447 and Chemotherapy with or without Durvalumab in Pancreatic Ductal Adenocarcinoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drugs, oleclumab and durvalumab, can shrink the size of your tumor when given with standard of care chemotherapy.

We are also doing this study to find out if this combination is safe and at what doses the study drugs are best for people to take.

What is the Condition Being Studied?

Metastatic Pancreatic Cancer

Who Can Participate in the Study?

Adults who:
- Have never received any treatment for their pancreatic cancer before
- Weigh more than 77 pounds
- Have been diagnosed with pancreatic adenocarcinoma
- Are able to provide a previously collected tumor sample or are willing to have a fresh biopsy of their tumor
- Do not have HIV, chronic or active Hepatitis B or C, or active Hepatitis A

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Go through a screening period which will last about 4 weeks
-Have physical exams
-Have lab tests and other screening tests to see if you qualify for the study

If you’re able to join, you will:
-Be randomized (a fair, 50/50 chance) to group A1 or A3
---Group A1 will take gemcitabine and nab-paclitaxel on Days 1, 8 and 15 of each 4 week treatment cycle
---Group A3 will take gemcitabine and nab-paclitaxel on Days 1, 8 and 15 of each 4 week treatment cycle, and oleclumab on Days 1 and 15 of the first and second 4 week treatment cycles, and then on Day 1 of each 4-week treatment cycle thereafter, and durvalumab on Day 1 of each 4-week treatment cycle
-Both treatment groups will have physical exams, lab tests, and other tests done throughout the study

Study Details

Full Title
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00100142
NCT: NCT03611556
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698