eoadjuvant immune checkpoint inhibition and novel IO combinations in early-stage colon cancer

Antoni van Leeuwenhoek0 sites155 target enrollmentSeptember 19, 2016

DrugsYervoy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Antoni van Leeuwenhoek
Enrollment: 155
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 19, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Antoni van Leeuwenhoek

Eligibility Criteria

Inclusion Criteria

•Study population. In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Stage 2\-3 (\>T3 and/or N\+) adenocarcinoma of the colon (and rectosigmoid considered as non\-rectal and not undergoing neoadjuvant treatment) for the MSI cohort;
•\- No signs of distant metastases on CT\-scan and physical examination;
•\- No clinical obstruction;
•\- No clinical symptoms or radiological suspicion of perforation;
•Colonoscopy must be performed after registration to obtain study\-specific biopsies. If biopsies are not possible, patients cannot be included in the study;
•WHO performance status of 0 or 1;
•Screening laboratory tests must meet the following criteria and should be obtained within 7 days prior to randomization/registration: WBC \> 2\.0 x 10^9/L, ANC \> 1\.5x10^9/L, platelets \> 100 x 10^9/L, Hemoglobin \> 5\.0mmol/L. Transfusion is allowed to obtain an adequate hemoglobin level. Liver function tests: total bilirubin \< 1\.5 upper limit of normal (ULN) (except for subjects with Gilbert syndrome, who can have total bilirubin \<3\.0 mg/dL); alkaline phosphatase \<2\.5 ULN; transaminases (ASAT/ALAT) \<3 x ULN; LDH \< 2 x ULN;
•Creatinine clearance (Cockcroft\-Gault) of \>40 ml/min;
•Women of childbearing potential (WOCBP)\* must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half\-lives) after the last dose of investigational drug;

Exclusion Criteria

•Study population. In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Stage 2\-3 (\>T3 and/or N\+) adenocarcinoma of the colon (and rectosigmoid considered as non\-rectal and not undergoing neoadjuvant treatment) for the MSI cohort;
•\- No signs of distant metastases on CT\-scan and physical examination;
•\- No clinical obstruction;
•\- No clinical symptoms or radiological suspicion of perforation;
•Colonoscopy must be performed after registration to obtain study\-specific biopsies. If biopsies are not possible, patients cannot be included in the study;
•WHO performance status of 0 or 1;
•Screening laboratory tests must meet the following criteria and should be obtained within 7 days prior to randomization/registration: WBC \> 2\.0 x 10^9/L, ANC \> 1\.5x10^9/L, platelets \> 100 x 10^9/L, Hemoglobin \> 5\.0mmol/L. Transfusion is allowed to obtain an adequate hemoglobin level. Liver function tests: total bilirubin \< 1\.5 upper limit of normal (ULN) (except for subjects with Gilbert syndrome, who can have total bilirubin \<3\.0 mg/dL); alkaline phosphatase \<2\.5 ULN; transaminases (ASAT/ALAT) \<3 x ULN; LDH \< 2 x ULN;
•Creatinine clearance (Cockcroft\-Gault) of \>40 ml/min;
•Women of childbearing potential (WOCBP)\* must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half\-lives) after the last dose of investigational drug;