Personalized Vaccine with SOC Chemo Followed by Nivo in Pancreatic Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 11, 2020

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Pancreatic Adenocarcinoma
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."

Trial Locations (1)

1011

CHUV Oncology Department, Lausanne

All Listed Sponsors
lead

Centre Hospitalier Universitaire Vaudois

OTHER