1381-0011 Phase II Study in Anal Carcinoma
Research type
Research Study
Full title
An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal
IRAS ID
279902
Contact name
Sheela Rao
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2019-004749-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 8 days
Research summary
The study is an open label, phase II trial of a new investigational drug called BI 754091 as monotherapy or BI 754091 in combination with another new Investigational drug, called BI 836880, in patients with advanced anal cancer. Eligible patients are those who have confirmed (either histologically or cytologically) locally-advanced or metastatic SCCA (squamous cell carcinoma of the anal canal)who progressed on or after chemotherapy. Patients with loco-regional anal cancer as initial diagnosis must have unresectable progressive locally advanced or metastatic SCCA after failure of at least one line (but not more than two lines) of previous systemic treatment unless ineligible for or intolerant to this systemic therapy. Patients with metastatic anal cancer as initial diagnosis must have failed one line of previous systemic treatment (chemotherapy ± radiotherapy) for metastatic anal cancer unless ineligible for or intolerant to this systemic treatment.
Patients will be assigned in a 1:1 ratio to one of 2 open label arms of treatment and will be administered IMP by infusion every 3 weeks until either disease progression, unacceptable treatment toxicity or withdrawal of patient consent.
The primary endpoint will be the Objective response (OR) defined as a best overall response of confirmed - Complete Response (CR) or Partial Response (PR) - according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. There will be a number of secondary endpoints - Duration of objective response (DoR); Progression-free survival (PFS); Overall survival (OS); Disease control (DC) all assessed by tumour imaging during the treatment period, and additional endpoints include Adverse events (AEs) from the time of treatment initiation until the end of the Residual Effect Period (REP); Drug related AEs from the time of treatment initiation until the end of the REP; Drug related AEs leading to dose reduction of BI 836880 and/or discontinuation of study treatment (i.e. both trial drugs) and assessment of biomarkers.REC name
London - South East Research Ethics Committee
REC reference
20/LO/0908
Date of REC Opinion
31 Jul 2020
REC opinion
Further Information Favourable Opinion