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Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours

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.
 
ClinicalTrials.gov Identifier: NCT03697304
Recruitment Status : Active, not recruiting
First Posted : October 5, 2018
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:

This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy. This means it may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors.

How long the participants are in the study depends on whether they benefit from treatment and whether they experience unacceptable side effects. The participants are put into different groups.

Each group receives BI 754091 in combination with another medicine.

The doctors check whether the tumors shrink or disappear. The doctors also check the general health of the participants.


Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: BI 754091 Drug: BI 754111 Drug: BI 836880 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple BI 754091 (Ezabenlimab) Anti-PD-1 Based Combination Regimens in PD-(L)1 naïve and PD-(L)1 Pretreated Patient Populations With Advanced and/or Metastatic Solid Tumours Who Have Had at Least One Line of Systemic Therapy
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 - Module A Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 754111
Solution for infusion
Experimental: Cohort 2 - Module A Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 754111
Solution for infusion
Experimental: Cohort 3 - Module A Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 754111
Solution for infusion
Experimental: Cohort 1 - Module C Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 836880
Solution for infusion
Experimental: Cohort 2 - Module C Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 836880
Solution for infusion
Experimental: Cohort 3 - Module C Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 836880
Solution for infusion
Experimental: Cohort 4 - Module C Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 836880
Solution for infusion
Experimental: Cohort 5 - Module C Drug: BI 754091
Solution for infusion
Other Name: ezabenlimab

Drug: BI 836880
Solution for infusion


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint of the trial is objective response (OR), defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator [ Time Frame: Up to 32 months ]

Secondary Outcome Measures :
  1. Duration of response (DoR), defined as the time from first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death among patients with OR [ Time Frame: Up to 32 months ]
  2. Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by the Investigator [ Time Frame: Up to 32 months ]
  3. Progression-free survival (PFS), defined as the time from first treatment until PD or death from any cause, whichever occurs earlier [ Time Frame: Up to 32 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Master Protocol:

  • Provision of signed and dated, written Master informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses.
  • Patient ≥18 years of age at the time of signature of the ICF.
  • Eastern Cooperative Oncology Group (ECOG) score: 0 or 1.
  • Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy.
  • Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be willing and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication.

Module A:

- Histologically confirmed diagnosis of one of the following cohorts:

  • Cohort 1 GEC - Locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro oesophageal adenocarcinoma (GEC) (defined as primary tumour localisation below the gastro oesophageal junction (GEJ) with prior anti-PD-1 or anti-PD-L1 based treated tumour.
  • Cohort 2 Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour with previously anti-PD-1 or anti-PD-L1 based treatment who progressed after achieving benefit
  • Cohort 3 Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD- 1/PD-L1 based treated tumour without achieving benefit.
  • All patients must have measurable lesions according to RECIST v1.1
  • Patient must agree to pre- and on-treatment tumour biopsies. If archived tumour tissue is available from the last treatment failure, sections may be supplied instead of a pre-treatment biopsy.

Module C:

  • Histologically confirmed diagnosis of one of the following cohorts:

    • Cohort 1: GEC: Locally advanced, unresectable or metastatic gastric adenocarcinoma or GEC.
    • Cohort 2: Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour (excluding NSCLC and melanoma) with previously anti-PD-1 or anti-PD-L1 based treatment which progressed after achieving benefit.
    • Cohort 3: Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD-1/PD-L1 based treated tumour without achieving benefit.
    • Cohort 4: Locally advanced, unresectable or metastatic second line or greater, microsatellite stable (MSS) colorectal cancer.
    • Cohort 5: Advanced Endometrial cancer: Endometrial carcinoma that is pMMR (Mismatch Repair-Proficient)/MSS and is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy.
  • All patients must have at least one measurable lesion according to RECIST v1.1
  • Further inclusion criteria apply

Exclusion Criteria

Master Protocol:

  • Any investigational treatment anti-tumour treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
  • More than one anti-PD-(L)1-based treatment regimen prior to entering study
  • Major surgery ('major' according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 months after screening, e.g., hip replacement.
  • Known history of severe hypersensitivity reactions to other mAbs or known hypersensitivity to the trial drugs or their excipients.
  • Presence of central nervous system (CNS) metastases, unless treated and asymptomatic and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to start of treatment.
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
  • Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. Patients who were permanently discontinued from previous anti-PD-1 or anti-PD-L1 therapy because of a immune-related adverse event (irAE).

Module A:

- Previous treatment with an anti-LAG-3 Agent

Module C:

  • Unresolved, Grade >1 toxicity before the start of treatment with the study drug except for hair loss (alopecia) and hypothyroidism that requires thyroid hormone supplements but is asymptomatic under therapy.
  • 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)
  • History of severe haemorrhagic or thromboembolic event in the past 12 months
  • Known inherited predisposition to bleeding or to thrombosis, in the opinion of the investigator - Further exclusion criteria apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697304


Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92093
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
Tallahassee, Florida, United States, 32308
Florida Cancer Specialists - East
West Palm Beach, Florida, United States, 33401
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Oklahoma
Oklahoma University School of Community Medicine
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Wisconsin
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z6
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
University College Hospital
London, United Kingdom, NW1 2BU
Guy's Hospital
London, United Kingdom, SE1 9RT
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03697304    
Other Study ID Numbers: 1381-0009
2018-002344-81 ( EudraCT Number )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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 https://www.mystudywindow.com/msw/datasharing 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 https://www.mystudywindow.com/msw/datasharing 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
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://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes