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A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04499352
Recruitment Status : Withdrawn (Not due to safety reasons (sponsor decision).)
First Posted : August 5, 2020
Last Update Posted : November 12, 2020
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 3, 2020
First Posted Date  ICMJE August 5, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE September 14, 2020
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
Objective response (OR) [ Time Frame: up to 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anal Canal Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: BI 754091
    BI 754091
  • Drug: BI 836880
    BI 836880
Study Arms  ICMJE
  • Experimental: treatment arm A
    Intervention: Drug: BI 754091
  • Experimental: treatment arm B
    • Drug: BI 754091
    • Drug: BI 836880
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 10, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
Actual Study Completion Date  ICMJE October 19, 2020
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 criteria.
  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.

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 investigator.
  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 treatment.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries Australia,   Belgium,   Spain
Administrative Information
NCT Number  ICMJE NCT04499352
Other Study ID Numbers  ICMJE 1381-0011
2019-004749-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP