Clinical Trials List
Protocol Number1381-0011
Completed
2020-07-24 - 2020-11-06
Phase II
Terminated4
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
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Trial Applicant
Boehringer Ingelheim
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 黃敬文 Division of Colorectal Surgery
- Wei-Chih Su Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- CHOU-CHEN CHEN Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張境夫 Division of Hematology & Oncology
- Jen-Shi Chen Division of Hematology & Oncology
- Pei-Wei Huang Division of Hematology & Oncology
- Mengting Peng Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
anal canal
Objectives
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.
Test Drug
BI 754091; BI 836880
Active Ingredient
BI 754091
BI 836880
BI 836880
Dosage Form
Concentrate for solution for infusion
Solution for Infusion
Solution for Infusion
Dosage
300 mg/15 mL/vial
100 mg/10 mL/vial
100 mg/10 mL/vial
Endpoints
Primary endpoint:
Objective response (OR)
Secondary endpoints:
Duration of objective response (DoR)
Progression-free survival (PFS)
Overall survival (OS)
Disease control (DC)
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).
All efficacy-related endpoints including progression will be evaluated
according to RECIST version 1.1, based on investigator assessment.
All tumour images will be sent to a central imaging unit to be
archived digitally. These images may be used to verify the
concordance for the determination of OR between investigator
assessment and central review.
Objective response (OR)
Secondary endpoints:
Duration of objective response (DoR)
Progression-free survival (PFS)
Overall survival (OS)
Disease control (DC)
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).
All efficacy-related endpoints including progression will be evaluated
according to RECIST version 1.1, based on investigator assessment.
All tumour images will be sent to a central imaging unit to be
archived digitally. These images may be used to verify the
concordance for the determination of OR between investigator
assessment and central review.
Inclution Criteria
Provision of signed, dated and written Informed Consent Form
(ICF) prior to any trial-specific procedures, sampling, or analyses
are performed.
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.
Patients must have histologically or cytologically documented
surgically unresectable locally-advanced or metastatic SCCA
(squamous cell carcinoma of the anal canal).
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 (chemoradiotherapy or
chemotherapy) for the metastatic anal cancer unless ineligible for
or intolerant to this systemic therapy.
All patients must have at least one measurable lesion according to
RECIST v1.1 criteria.
Eastern Cooperative Oncology Group performance status (ECOG)
score: 0 to 1
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.
Patients must be willing to allow 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.
(ICF) prior to any trial-specific procedures, sampling, or analyses
are performed.
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.
Patients must have histologically or cytologically documented
surgically unresectable locally-advanced or metastatic SCCA
(squamous cell carcinoma of the anal canal).
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 (chemoradiotherapy or
chemotherapy) for the metastatic anal cancer unless ineligible for
or intolerant to this systemic therapy.
All patients must have at least one measurable lesion according to
RECIST v1.1 criteria.
Eastern Cooperative Oncology Group performance status (ECOG)
score: 0 to 1
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.
Patients must be willing to allow 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.
Exclusion Criteria
Current or prior treatment with any systemic anti-cancer therapy
or any investigational product either within 28 days or less than 5
half-lives before start of treatment
Major injuries and/or surgery or bone fracture within 4 weeks of
start of treatment and/or planned surgical procedures during the
trial period.
Significant cardiovascular/cerebrovascular diseases (i.e.
uncontrolled hypertension, unstable angina, history of infarction
within past 6 months, congestive heart failure > NYHA II).
Known inherited predisposition to bleeding or to thrombosis in the
opinion of the investigator.
History of severe hemorrhagic or thromboembolic event in the
past 12 months (excluding central venous catheter thrombosis and
peripheral deep vein thrombosis).
Patients who require full-dose anticoagulation (according to local
guidelines).
Prior treatment with prior anti-PD-1, anti-PD-L1, or anti CTLA-4
treatment
Prior treatment with any antiangiogenic agent
or any investigational product either within 28 days or less than 5
half-lives before start of treatment
Major injuries and/or surgery or bone fracture within 4 weeks of
start of treatment and/or planned surgical procedures during the
trial period.
Significant cardiovascular/cerebrovascular diseases (i.e.
uncontrolled hypertension, unstable angina, history of infarction
within past 6 months, congestive heart failure > NYHA II).
Known inherited predisposition to bleeding or to thrombosis in the
opinion of the investigator.
History of severe hemorrhagic or thromboembolic event in the
past 12 months (excluding central venous catheter thrombosis and
peripheral deep vein thrombosis).
Patients who require full-dose anticoagulation (according to local
guidelines).
Prior treatment with prior anti-PD-1, anti-PD-L1, or anti CTLA-4
treatment
Prior treatment with any antiangiogenic agent
The Estimated Number of Participants
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Taiwan
10 participants
-
Global
190 participants
