Study With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02648282|
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Cyclophosphamide Drug: GVAX Drug: Pembrolizumab Radiation: SBRT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the Pancreas|
|Actual Study Start Date :||July 12, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
|Experimental: Cyclophosphamide, Pembrolizumab, GVAX, SBRT||
200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses.
2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses.
200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 8 doses.
Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX).
Other Name: Stereotactic Body Radiation Therapy
- Distant Metastasis Free Survival (DMFS) [ Time Frame: 4 years ]
- Overall Survival (OS) [ Time Frame: 4 years ]
- Local Progression Free Survival (LPFS) [ Time Frame: 4 years ]
- Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 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): NCT02648282
|Contact: Beth Onners, RN, BSN, MSNfirstname.lastname@example.org|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Beth Onners, RN, BSN, MSN 410-502-2800 email@example.com|
|Contact: Lei Zheng, MD, PhD|
|Principal Investigator:||Lei Zheng, MD, PhD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|