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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04499352

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
Scientific 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
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Canal Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - BI 754091
Treatment: Drugs - BI 836880

Experimental: treatment arm A -

Experimental: treatment arm B -

Treatment: Drugs: BI 754091
BI 754091

Treatment: Drugs: BI 836880
BI 836880

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Objective response (OR)
Timepoint [1] 0 0
up to 3 years
Secondary outcome [1] 0 0
Duration of objective response (DoR)
Timepoint [1] 0 0
up to 3 years
Secondary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
up to 3 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
up to 3 years
Secondary outcome [4] 0 0
Disease control (DC)
Timepoint [4] 0 0
up to 3 years
Secondary outcome [5] 0 0
Adverse events (AEs)
Timepoint [5] 0 0
up to 3 years
Secondary outcome [6] 0 0
Drug related AEs from the time of treatment initiation until the end of the Residual Effect Period (REP)
Timepoint [6] 0 0
up to 3 years
Secondary outcome [7] 0 0
Drug related AEs leading to dose reduction of BI 836880 and/or discontinuation of study treatment (i.e. both trial drugs)
Timepoint [7] 0 0
up to 3 years

Key inclusion criteria
1. Signed and dated written Informed Consent Form (ICF) in accordance with ICH-GCP and
local legislation prior to admission to the trial.

2. Patients =18 years of age or over the legal age of consent in countries where that is
greater than 18 years at the time of signature of the ICF.

3. Patients must have histologically or cytologically documented surgically unresectable
locally-advanced or metastatic Squamous cell carcinoma of the anal canal (SCCA).

4. 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 (no prior treatment for
loco-regional cancer) must have failed one line of previous systemic treatment
(chemotherapy ± radiotherapy) for the metastatic anal cancer unless ineligible for or
intolerant to this systemic treatment. (Patients with metastatic anal cancer as
initial diagnosis who have received two or more lines of systemic treatment for the
metastatic anal cancer are not eligible for the study.)

5. All patients must have at least one measurable lesion according to RECIST v1.1

6. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1

7. All patients must be willing to undergo blood testing for human immunodeficiency virus
(HIV) presence in the blood if not tested within the past 6 months prior to signature
of ICF for this trial.

For patients confirmed as HIV positive, all of the following (a-d) applies:

1. CD4+ count = 250 cells/µL

2. Undetectable viral load (local lab assessment)

3. Must be currently receiving Highly Active Antiretroviral Therapy

4. A HIV/Infectious Diseases specialist must be consulted or patient must be under
the care of the HIV/Infectious Diseases specialist

8. Patients must be willing to allow programmed cell death ligand 1 (PD-L1) status
assessment by one of following options.

Preference is given to fresh tumour biopsy sample collection at baseline before
receiving first trial medication. In case a fresh tumour biopsy cannot be obtained
(e.g. inaccessible lesions or patient safety concern), archival tissue will be
requested. If neither is available any previous historical information regarding PD-L1
status should be collected via eCRF. Exceptions may be considered after consultation
with and approval by the Sponsor.

9. Male or female patients. Women of childbearing potential (WOCBP) and men able to
father a child must be ready and able to use highly effective methods of birth control
per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly, for the entire duration of the trial treatment intake and
for 6 months after the end of the trial treatment. A list of contraception methods
meeting these criteria is provided in the patient information.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Current or prior treatment with any systemic anti-cancer therapy or any
investigational product (or device) either within 28 days or less than 5 half-lives
(whichever is shorter) before start of trial treatment.

2. Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment,
or planned surgical procedures during the trial period.

3. Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension,
unstable angina, history of infarction within past 6 months, congestive heart failure
> New York Heart Association (NYHA) II).

Uncontrolled hypertension is defined as: blood pressure in rested and relaxed
condition = 140 mmHg, systolic or = 90 mmHg diastolic (with or without medication)

4. Known inherited predisposition to bleeding or to thrombosis in the opinion of the

5. History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding
central venous catheter thrombosis and peripheral deep vein thrombosis).

6. Patients who require full-dose anticoagulation (according to local guidelines). No
Vitamin K antagonist and other anticoagulation allowed; Low-Molecular-Weight-Heparin
(LMWH) and acetylsalicylic acid (ASA) allowed only for prevention not for curative

7. Prior treatment with anti-PD-1, anti-PD-L1, or anti CTLA-4 treatment

8. Prior treatment with any antiangiogenic agent (e.g. bevacizumab, cediranib,
aflibercept, vandetanib, XL-184, sunitinib, etc.) Further exclusion criteria apply.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0
Country [4] 0 0
State/province [4] 0 0
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Country [6] 0 0
State/province [6] 0 0
Country [7] 0 0
State/province [7] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Boehringer Ingelheim

Ethics approval
Ethics application status

Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04499352