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ACTIVE NOT RECRUITING
NCT04627246
PHASE1

Personalized Vaccine with SOC Chemo Followed by Nivo in Pancreatic Cancer

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

Summary

Phase Ib clinical trial using Autologous Dendritic Cell Vaccine Loaded with Personalized Peptides (PEP) in order to stimulate/induce both innate and adaptive immunity by activating T-cells and Natural Killer (NK) cells, combined with standard of care (SOC) adjuvant chemotherapy, followed by nivolumab, an antibody against Programmed Cell Death 1 (PD-1), to maintain and boost the vaccine's effect in patients with non-metastatic resectable pancreatic adenocarcinoma

Official title: A Phase Ib Study of the Combination of Personalized Autologous Dendritic Cell Vaccine and Standard of Care Adjuvant Chemotherapy Followed by Nivolumab for Resected Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2020-09-11

Completion Date

2028-09

Last Updated

2025-02-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous Dendritic Cell Vaccine Loaded with Personalized Peptides (PEP-DC vaccine)

SOC: Subgroup1: intravenous mFOLFIRINOX for twelve 14-day cycles. Subgroup2: intravenous gemcitabine twice, on days 1 and 8, and oral capecitabine for 14 days of 21-day cycles, for eight cycles. PEP-DC vaccine: At least 5 subcutaneous vaccinations starting on cycle 8 (subgroup1) or cycle 5 (subgroup2) of chemotherapy: Subgroup1: every 4 weeks, on day 3 of every second 14-day cycle, and then every 4 weeks starting from the first nivolumab administration. Subgroup2: Every 3 weeks, on day 9 of each 21-day cycle, and then every 4 weeks starting from the second nivolumab administration. Nivolumab for a maximal duration of 2 years: intravenous, starting after the last chemotherapy cycle. Administered as flat dose of 240mg every 2 weeks during 14 weeks, then as flat dose of 480 mg every 4 weeks until the last vaccination. Then, as a maintenance therapy at 480 mg every 4 weeks until appearance of new lesions or unacceptable toxicity.

Locations (1)

CHUV Oncology Department

Lausanne, Canton of Vaud, Switzerland