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.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

May 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple 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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: BI 754091
Solution for infusion
Drug: BI 754111
Solution for infusion

Study Arms

Experimental: Cohort 1
Module A
Experimental: Cohort 2
Module A
Experimental: Cohort 3
Module A

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

110

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 21, 2021

Estimated Primary Completion Date

May 21, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)1 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. 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. - A maximum of 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, or a patient removed from previous anti-PD-1 or anti-PD-L1 therapy because of a severe immune-related adverse event (irAE). Module A: - Previous treatment with an anti-LAG-3 agent - The use of systemic steroids - Autoimmune disease

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

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

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

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

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