- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499352
A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed and dated written Informed Consent Form (ICF) in accordance with ICH-GCP and local legislation prior to admission to the trial.
- 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 Squamous cell carcinoma of the anal canal (SCCA).
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.)
- All patients must have at least one measurable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 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.
For patients confirmed as HIV positive, all of the following (a-d) applies:
- CD4+ count ≥ 250 cells/μL
- Undetectable viral load (local lab assessment)
- Must be currently receiving Highly Active Antiretroviral Therapy
- A HIV/Infectious Diseases specialist must be consulted or patient must be under the care of the HIV/Infectious Diseases specialist
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.
- 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.
Exclusion Criteria:
- 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.
- Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, 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 > 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)
- 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). No Vitamin K antagonist and other anticoagulation allowed; Low-Molecular-Weight-Heparin (LMWH) and acetylsalicylic acid (ASA) allowed only for prevention not for curative treatment.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti CTLA-4 treatment
- Prior treatment with any antiangiogenic agent (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc.) Further exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm A
|
BI 754091
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Experimental: treatment arm B
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BI 754091
BI 836880
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response (OR)
Time Frame: up to 3 years
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of objective response (DoR)
Time Frame: up to 3 years
|
up to 3 years
|
Progression-free survival (PFS)
Time Frame: up to 3 years
|
up to 3 years
|
Overall survival (OS)
Time Frame: up to 3 years
|
up to 3 years
|
Disease control (DC)
Time Frame: up to 3 years
|
up to 3 years
|
Adverse events (AEs)
Time Frame: up to 3 years
|
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
|
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
|
up to 3 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1381-0011
- 2019-004749-33 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anal Canal Squamous Cell Carcinoma
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National Cancer Institute (NCI)Active, not recruitingAnal Canal Squamous Cell Carcinoma | Metastatic Anal Canal Carcinoma | Stage IV Anal Canal Cancer AJCC v6 and v7United States, Canada
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingAnal Basaloid Carcinoma | Anal Canal Cloacogenic Carcinoma | Anal Canal Squamous Cell Carcinoma | Anal Margin Squamous Cell Carcinoma | Stage I Anal Cancer AJCC v8 | Stage IIA Anal Cancer AJCC v8United States
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingAnal Canal Cancer | Anal Squamous Cell Carcinoma | Anal Cancer | Anal Canal Cancer Stage IIIChina
-
Incyte CorporationCompletedSquamous Cell Carcinoma of Anal CanalSpain, United Kingdom, United States, Germany, Belgium, France, Denmark, Italy, Norway
-
Instituto do Cancer do Estado de São PauloCompleted
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Centre Hospitalier Universitaire VaudoisTerminated
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Active, not recruitingAnal Squamous Cell Carcinoma | Anal Basaloid Carcinoma | Anal Canal Cloacogenic Carcinoma | Metastatic Anal Canal Carcinoma | Recurrent Anal Canal Carcinoma | Stage IIIB Anal Canal Cancer | Stage IV Anal Canal CancerUnited States
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National Cancer Institute (NCI)RecruitingAnal Canal Cloacogenic Carcinoma | Metastatic Anal Squamous Cell Carcinoma | Recurrent Anal Squamous Cell Carcinoma | Stage III Anal Cancer AJCC v8 | Stage IV Anal Cancer AJCC v8 | Unresectable Anal Squamous Cell Carcinoma | Anal Basaloid Squamous Cell CarcinomaUnited States
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Grupo Espanol Multidisciplinario del Cancer DigestivoHoffmann-La RocheRecruitingSquamous Cell Carcinoma of the Anal CanalSpain
-
Dr. Te VuongYM BioSciencesTerminatedSquamous Cell Carcinoma of Anal CanalCanada
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