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PDR001

bevacizumab

Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)

mFOLFOX6

Novartis Pharmaceuticals

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.

Phase Ib study, safety run-in (N=\~6 pts) followed with an expansion (N=\~86 pts). One single arm: PDR001 in combination with bevacizumab and mFOLFOX6

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

ElevatION: CRC-101: A Phase Ib Study of PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1

Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

100 mg lyophilisate in vial received 400 mg every 4 weeks

spartalizumab (PDR001)

120 mg once daily first 21 days of each 28-day cycle (=4 weeks)

regorafenib

This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.

Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.

Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.

Severity including dose interruptions and reductions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer	NCT03176264	Metastatic Colo...	PDR001 bevacizumab mFOLFOX6	18 Years -	Novartis
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer	NCT03081494	Metastatic Colo...	spartalizumab (... regorafenib	18 Years -	Novartis

Spots Global Cancer Trial Database for cms4

Every month we try and update this database with for cms4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cms4

Every month we try and update this database with for cms4 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cms4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.