Status and phase
Conditions
Treatments
About
This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.
Full description
In the first stage, 13 evaluable patients will be accrued per cohort. Evaluable is defined as: at least one administration of nivolumab and availability of paired biopsies for immunohistochemistry (for induction treatment cohorts pre-induction and pre-nivolumab biopsies).
If there are 1 or no responses observed in these 13 patients, the cohort will be stopped. Otherwise, 21 additional patients will be accrued for a total of 34.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
52 participants in 3 patient groups
Loading...
Central trial contact
Marleen Kok, MD; Leonie Voorwerk, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal