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History of Changes for Study: NCT04499352
A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
Latest version (submitted November 12, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 3, 2020 None (earliest Version on record)
2 September 10, 2020 Study Status
3 September 15, 2020 Recruitment Status, Study Status and Contacts/Locations
4 September 23, 2020 Contacts/Locations and Study Status
5 October 5, 2020 Study Status and Contacts/Locations
6 October 22, 2020 Contacts/Locations, References and Study Status
7 November 10, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 November 12, 2021 IPDSharing and Study Status
Comparison Format:

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Study NCT04499352
Submitted Date:  August 3, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1381-0011
Brief Title: A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
Official 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 IDs: 2019-004749-33 [EudraCT Number]
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Not yet recruiting
Study Start: September 7, 2020
Primary Completion: March 3, 2023 [Anticipated]
Study Completion: September 14, 2023 [Anticipated]
First Submitted: August 3, 2020
First Submitted that
Met QC Criteria:
August 3, 2020
First Posted: August 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 3, 2020
Last Update Posted: August 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Anal Canal Squamous Cell Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: treatment arm A Drug: BI 754091
BI 754091
Experimental: treatment arm B Drug: BI 754091
BI 754091
Drug: BI 836880
BI 836880
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective response (OR)
[ Time Frame: up to 3 years ]

Secondary Outcome Measures:
1. Duration of objective response (DoR)
[ Time Frame: up to 3 years ]

2. Progression-free survival (PFS)
[ Time Frame: up to 3 years ]

3. Overall survival (OS)
[ Time Frame: up to 3 years ]

4. Disease control (DC)
[ Time Frame: up to 3 years ]

5. Adverse events (AEs)
[ Time Frame: up to 3 years ]

6. Drug related AEs from the time of treatment initiation until the end of the Residual Effect Period (REP)
[ Time Frame: up to 3 years ]

7. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Boehringer Ingelheim
Telephone: 1-800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html 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 http://trials.boehringer-ingelheim.com/ 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 Information:
Study Protocol
Statistical Analysis Plan (SAP)
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'.
URL: https://trials.boehringer-ingelheim.com
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services