Nivolumab, Ipilimumab and Chemoradiation in Pancreatic Cancer.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 2, 2020

Primary Completion Date

May 24, 2024

Study Completion Date

December 5, 2024

Conditions
Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer
Interventions
DRUG

Gemcitabine

800 mg/m2 Day 1, 8, 15: Q4W IV Infusion

DRUG

Nab-paclitaxel

100 mg/m2 Day 1, 8, 15: Q4W IV Infusion

DRUG

Nivolumab

3 mg/kg Day 1, Q4W IV Infusion

DRUG

Ipilimumab

1 mg/kg Day 1 Cycle 1 IV Infusion

RADIATION

SBRT

"Patients will be planned and treated with SBRT on a MRidian MR guided Linac.~Prescription dose shall be according to the following specifications:~* Prescription dose shall be according to the following specifications:~* A total dose of 24 Gy in 3 fractions (3 fractions/week) are prescribed as the mean dose to the PTV.~* Pauses are accepted but the treatment should be delivered within 10 calendar days.~* PTV should be covered by 95% isodose (PTV D99% \>95%)."

Trial Locations (1)

2730

Herlev & Gentofte University Hospital, Denmark, Herlev

All Listed Sponsors
lead

Herlev Hospital

OTHER

NCT04247165 - Nivolumab, Ipilimumab and Chemoradiation in Pancreatic Cancer. | Biotech Hunter | Biotech Hunter