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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.

NCT03697304

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Gastric Adenocarcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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.
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 1381-0009
  • SECONDARY ID: 2018-002344-81
  • NCT ID: NCT03697304

Conditions

  • Neoplasm Metastasis

Interventions

DrugSynonymsArms
BI 754091Cohort 1 - Module A
BI 754111Cohort 1 - Module A
BI 836880Cohort 1 - Module C

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - Module AExperimental
  • BI 754091
  • BI 754111
Cohort 2 - Module AExperimental
  • BI 754091
  • BI 754111
Cohort 3 - Module AExperimental
  • BI 754091
  • BI 754111
Cohort 1 - Module CExperimental
  • BI 754091
  • BI 836880
Cohort 2 - Module CExperimental
  • BI 754091
  • BI 836880
Cohort 3 - Module CExperimental
  • BI 754091
  • BI 836880
Cohort 4 - Module CExperimental
  • BI 754091
  • BI 836880
Cohort 5 - Module CExperimental
  • BI 754091
  • BI 836880

Eligibility 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 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.

        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.

          -  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

        Module C:

          -  Persistent toxicity from previous treatments that has not resolved to ≤Grade 1 with
             the exception of alopecia

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

Last Updated

October 5, 2020