Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02866383
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2016-08-08
Brief Title:
Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CheckPAC
Brief 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 andor 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 11 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 mgkg of intravenous nivolumab IV on day 1 and every 2 weeks q2w Arm A or SBRT consisting of 15 Gy day 1 with 3 mgkg of IV nivolumab day 1 q2w and 1 mgkg 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 investigators judgment
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 investigators judgment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None