The objective of this trial is to assess anti-tumour activity of BI 754091 as monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who progressed on or after chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Asan Medical Center
Seoul, South Korea
Objective response (OR)
Time frame: up to 3 years
Duration of objective response (DoR)
Time frame: up to 3 years
Progression-free survival (PFS)
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
Disease control (DC)
Time frame: up to 3 years
Adverse events (AEs)
Time frame: up to 3 years
Drug related AEs from the time of treatment initiation until the end of the Residual Effect Period (REP)
Time frame: up to 3 years
Drug related AEs leading to dose reduction of BI 836880 and/or discontinuation of study treatment (i.e. both trial drugs)
Time frame: up to 3 years
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