Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03153410|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Cyclophosphamide Drug: GVAX Drug: Pembrolizumab Drug: IMC-CS4||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of a GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With a PD-1 Blockade Antibody (Pembrolizumab) and a Macrophage Targeting Agent (CSF1R Inhibitor) for the Treatment of Patients With Borderline Resectable Adenocarcinoma of the Pancreas|
|Actual Study Start Date :||September 27, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
|Experimental: Cyclophosphamide, GVAX, Pembrolizumab and IMC-CS4||
200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses.
Other Name: CY
5E8 cells is to be administered one day after CY, pembrolizumab, and IMC-CS4/ LY3022855 for a total of eight doses.
Pancreatic cancer vaccine Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo
Other Name: Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo
200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 18 doses.
Other Name: MK-3475, KEYTRUDA®
75 mg for dose level 1 and 100 mg at dose level 2 will be administered (Day 1, Day 8 and Day 15) as a 30 minute(s) IV infusion one day prior to GVAX pancreas vaccine for a total 18 doses.
Other Name: LY3022855
- CD8 T cell density in the primary tumor after neoadjuvant administration of combination immunotherapy by immunohistochemistry (IHC) [ Time Frame: 2 years ]
- Number of participants experiencing study drug-related toxicities [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 2 years ]
- Disease free survival (DFS) [ Time Frame: 2 years ]
- Objective response rate (ORR) by immune-related RECIST criteria (irRC) [ Time Frame: 2 years ]
- Surgical resectability rate of borderline resectable pancreatic cancer (BRPC) [ Time Frame: 2 years ]
- Pathologic response rate of patients with BRPC [ Time Frame: 2 years ]
- Progression free survival (PFS) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153410
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Ana DeJesus, MD||Johns Hopkins University|