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
- Conditions
- Neoplasm Metastasis
- Interventions
- Drug: BI 754091Drug: BI 754111Drug: BI 836880
- Registration Number
- NCT03697304
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 212
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 - Module A BI 754111 - Cohort 3 - Module A BI 754111 - Cohort 5 - Module C BI 836880 - Cohort 1 - Module A BI 754091 - Cohort 3 - Module A BI 754091 - Cohort 1 - Module C BI 754091 - Cohort 2 - Module C BI 754091 - Cohort 3 - Module C BI 836880 - Cohort 1 - Module C BI 836880 - Cohort 2 - Module C BI 836880 - Cohort 3 - Module C BI 754091 - Cohort 2 - Module A BI 754091 - Cohort 2 - Module A BI 754111 - Cohort 4 - Module C BI 754091 - Cohort 4 - Module C BI 836880 - Cohort 5 - Module C BI 754091 -
- Primary Outcome Measures
Name Time Method 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 Up to 32 months
- Secondary Outcome Measures
Name Time Method 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 Up to 32 months 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 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 Up to 32 months
Trial Locations
- Locations (17)
Florida Cancer Specialists-Fort Myers-52980
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists-Saint Petersburg-52979
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists-Sarasota-61670
🇺🇸Tallahassee, Florida, United States
Tennessee Oncology, PLLC-Nashville-52568
🇺🇸Nashville, Tennessee, United States
Sarah Cannon Research Institute-London-65253
🇬🇧London, United Kingdom
University of California San Diego
🇺🇸La Jolla, California, United States
Florida Cancer Specialists - East
🇺🇸West Palm Beach, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Oklahoma University School of Community Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Tennessee Oncology
🇺🇸Chattanooga, Tennessee, United States
Medical College Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Cross Cancer Institute (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom