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Title:
J1994: Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined with Nivolumab and Ipilimumab for Patients with Resected MMR-p Colorectal and Pancreatic Cancer.
Protocol Number:
J1994
Phase:
Phase I
Physician:
Nilofer Azad
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This research is being done to study how the combination of the KRAS peptide vaccine, nivolumab and ipilimumab will work in resected microsatellite stable (MSS) pancreatic or colorectal cancer. This study will examine the safety of these drugs in resected pancreatic or colorectal cancer. Another goal of the study is to learn more about the immune effects of the vaccine and drugs in the study.
Eligibility:
Patients with resected pancreatic adenocarcinoma and MSS colorectal cancer who have completed standard of care neoadjuvant and/or adjuvant chemotherapy and/or radiotherapy and have remained disease free on imaging will be considered for enrollment. Subjects must have histologically- or cytologically-proven adenocarcinoma of the pancreas (PDA) or MSS colorectal (CRC) that are staged T4N1, any stage N2, or resected M1 with no evidence of disease. Last dose of adjuvant chemotherapy or radiation therapy administered within 6 months of screening date. Must have one of the six KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D or KRASG12R) in vaccine expressed in tumor. No prior immunotherapy. No autoimmune disease. Good physical condition, good blood counts, and organ function.
Treatment:
If you are eligible to participate in this study based on the screening tests, you will receive KRAS peptide vaccine, nivolumab and ipilimumab for a total of a year or until the cancer recurs. Prime Phase: KRAS peptide vaccine on Cycle 1 (Days 1, 8, 15) and Cycle 2 (Day 1)Nivolumab intravenously every 3 weeks for 4 doses; Cycles 1-4 (Day 1)Ipilimumab intravenously every 6 weeks for 2 doses; Cycle 1 and 3 (Day 1)Boost Phase: KRAS peptide vaccine every 8-9 week intervals on Cycles 5, 7, 9, 11 and 13 (Day 1), Nivolumab intravenously every 4 weeks on Cycles 5-14 (Day 1)
Population:
Adult
Last Update
08/11/2020 05:02 AM