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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03697304
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The aim of this study is to assess the efficacy of BI 754091 in combination with other checkpoint inhibitors or anticancer medications in diverse tumour type cohorts.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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 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 : March 7, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : May 21, 2021

Arm Intervention/treatment
Experimental: Cohort 1
Module A
Drug: BI 754091
Solution for infusion

Drug: BI 754111
Solution for infusion

Experimental: Cohort 2
Module A
Drug: BI 754091
Solution for infusion

Drug: BI 754111
Solution for infusion

Experimental: Cohort 3
Module A
Drug: BI 754091
Solution for infusion

Drug: BI 754111
Solution for infusion

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 ]

Information from the National Library of Medicine

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

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 to 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.
  • 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.
  • Known presence of symptomatic central nervous system (CNS) metastases, unless 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
  • Further exclusion criteria apply

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 identifier (NCT number): NCT03697304

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Contact: Boehringer Ingelheim 1-800-243-0127

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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Razelle Kurzrock    +001 (858) 246-1102   
United States, Florida
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact: Ivor Percent    +001 (239) 274-9930   
Florida Cancer Specialists Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Maen Hussein    727-216-1143   
Florida Cancer Specialists Recruiting
Tallahassee, Florida, United States, 32308
Contact: Viralkumar Bhanderi    850-877-8166   
Florida Cancer Specialists - East Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Todd Gersten    561-366-4100   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Greg Durm    317-656-4260   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: John Hamm    +001 (502) 629-2500   
United States, Oklahoma
Oklahoma University School of Community Medicine Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Susanna Ulahannan    +001 (405) 271-8001   
United States, Tennessee
Tennessee Oncology Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Edward Arrowsmith    +001 (423) 7027897   
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell    +001 (615) 329-7274   
United States, Wisconsin
Medical College Of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Deepak Kilari    414-805-6700   
Canada, Alberta
Cross Cancer Institute (University of Alberta) Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy Chu    780-432-8248   
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Aaron Hansen    416-946-4501 ext. 2479   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT03697304     History of Changes
Other Study ID Numbers: 1381-0009
2018-002344-81 ( EudraCT Number )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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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
Pathologic Processes