Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer: A phase III randomised study. - POLEM

The Royal Marsden NHS Foundation Trust0 sites402 target enrollmentJune 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Male or female subjects aged \=18 years
•2\.ECOG PS 0/1
•3\.Histologically proven, stage III (i.e., any T, N1 or N2, M0\) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tumour above the peritoneal reflection \- that is, at least 15 cm from the anal margin).
•4\.Fully surgically resected tumour with clear resection margins (i.e., \>1 mm)
•5\.Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre\-operative biopsy samples or resection specimens of at least one of the following proteins: MLH1, MSH2, MSH6, PMS2\) or centrally confirmed POLE exonuclease domain mutated tumour (in subjects \<50 years old with pMMR tumours)
•6\.Absence of metastases as shown by post\-operative CT scan
•7\.Absence of major post\-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy
•8\.Adequate hematological function defined by absolute neutrophil count (ANC) \=1\.5 × 109/L, platelet count \=100 × 109/L, and hemoglobin \=9 g/dL (blood transfusion before recruitment is allowed)
•9\.Adequate hepatic function defined by a total bilirubin level \=1\.5 × the upper limit of normal (ULN) range and AST and ALT levels \=2\.5 × ULN
•10\.Adequate renal function defined by an estimated creatinine clearance \=30 mL/min according to the Cockcroft\-Gault formula (or local institutional standard method)

•1\.Rectal tumours (as defined by the presence of the inferior pole of the tumour below the peritoneal reflection \- that is, \<15 cm from the anal margin).
•2\.Inability to start adjuvant chemotherapy within 12 weeks after surgery
•3\.Administration of neoadjuvant systemic chemotherapy or radiotherapy before surgical resection of colon cancer
•4\.Prior organ transplantation, including allogeneic stem cell transplantation
•5\.Significant acute or chronic infections including, among others:
•\- known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•\- positive test for HBV surface antigen or anti\-HCV antibody and confirmatory HCV RNA test
•6\.Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
•\- Subjects with diabetes type I, vitiligo, psoriasis, hypo\- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
•\- Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \=10 mg/day of prednisone or equivalent