drugset / Trial / NCT03176264

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

NCT03176264

Phase 1 Terminated 1 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis). The study was terminated early due to company decision.

Timeline

Start
2017-09-25
Primary completion
2018-01-30
Completion
2018-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Spartalizumab Monoclonal antibody 400 mg
Background Bevacizumab Monoclonal antibody 5 mg/kg
Background Leucovorin Small molecule 400 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background fluorouracil Small molecule 2400 mg/m2

Indications