NCT02866383

Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients

A Prospective Randomized, Open-label Phase 2 Study of Immune Checkpoint Inhibition, Nivolumab With or Without Ipilimumab in Combination With Radiation Therapy in Pretreated Patients With Metastatic Pancreatic Cancer or Biliary Tract Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label phase 2 study in patients with metastatic PC or BTC refractory or intolerant to at least one line of prior systemic chemotherapy with gemcitabine or platinum-containing regimens to determine the efficacy and safety of nivolumab or nivolumab plus ipilimumab administered concurrently with high dose RT. Patients with metastatic PC or BTC who are feasible candidates for radiation and biopsy of primary and/or metastatic lesions will be included.

Detailed description

This was a randomized phase II trial conducted at Herlev \& Gentofte Hospital. Patients were stratified according to PS and randomized into two arms (1:1) (Appendix Figure A1 and Data Supplement, online only). Patients received SBRT consisting of 15 Gy (day 1) to a single primary or metastatic lesion with 3 mg/kg of intravenous nivolumab (IV) on day 1 and every 2 weeks (q2w) (Arm A), or SBRT consisting of 15 Gy (day 1) with 3 mg/kg of IV nivolumab (day 1) q2w and 1 mg/kg of IV ipilimumab on day 1 and every 6 weeks (Arm B). A safety phase involving a run-in assessment of three patients from each arm (n = 6) was followed by the expansion phase. The patients were monitored for dose-limiting toxicities prior to the expansion. Treatment was continued for a maximum of 52 weeks or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or clear clinical deterioration according to the investigator's judgment.

Conditions

• Metastatic Pancreatic Cancer
• Metastatic Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	3 mg/kg is given over 60 minutes I.V. on day 1 just after radiation and then every 2 weeks (q2w)
DRUG	Ipilimumab	1 mg/kg is given over 90 minutes I.V. on day 1 30 minutes after the completion of nivolumab infusion and then every 6 weeks IV (q6w)
RADIATION	Radiotherapy	15 Gy x 1 fraction given on day 1

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-01-05
• Completion: 2022-11-30
• First posted: 2016-08-15
• Last updated: 2023-09-22

Locations

1 site across 1 country: Denmark