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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
400 mg every 4 weeks
5 mg/kg every 2 weeks
Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Incidence of Dose-limiting toxicity (DLT)
Time frame: 12 months
Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1
Time frame: 19 months
Overall response rate (ORR) per central assessment using RECIST v1.1
Time frame: Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Overall survival (OS)
Time frame: Every 3 months after last visit up to 1 year after last patient last visit
Progression free survival
Time frame: Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Duration of response (DOR)
Time frame: Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Disease control rate (DCR)
Time frame: Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Time to response (TTR)
Time frame: Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit
Ctrough
Time frame: Through end of treatment completion, an average of 14 months
Cmax
Time frame: Through end of treatment completion, an average of 14 months
Area under the curve (AUC)
Time frame: Through end of treatment completion, an average of 14 months
Antidrug antibodies (ADA)
Time frame: Through end of treatment completion, an average of 14 months
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