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 : July 21, 2020
|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 2021|
|Estimated Study Completion Date :||July 2021|
|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 ]
- Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648282
|Contact: Beth Onners, RN, BSN, MSNemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Lei Zheng, MD, PhD|
|Principal Investigator:||Lei Zheng, MD, PhD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|