At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Metastatic Pancreatic Cancer and Metastatic Biliary Tract Cancer. Completed, enrolled 160 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
3 mg/kg is given over 60 minutes I.V. on day 1 just after radiation and then every 2 weeks (q2w)
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)
15 Gy x 1 fraction given on day 1