Nivolumab With Ipilimumab Combined With TGFβ-15 Peptide Vaccine and Radiotherapy for Pancreatic Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 3, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
Pancreatic Cancer
Interventions
DRUG

Nivolumab

3 mg/kg (up to 240 mg maximum) as i.v. infusion on day 1 (± 3 days) of each 14-day treatment cycle

DRUG

Ipilimumab

1 mg/kg as i.v. infusion on day 1 cycle 1 and subsequently every 6 weeks (± 3 days)

RADIATION

SBRT

SBRT: 15 Gy x 1 on a single site of disease on day 1 cycle 1

BIOLOGICAL

TGFβ-B-15 peptide

Vaccine (500 μl aqueous solution of 200 μg TGFβ-B-15 peptide mixed to an emulsion with 500μl Montanide ISA-51) as s.c. injection on day 1 of the first 6 cycles and subsequently every 4 weeks (± 3 days)

Trial Locations (1)

2730

Herlev & Gentofte University Hospital, Denmark, Herlev

All Listed Sponsors
lead

Inna Chen, MD

OTHER