Trials / Completed
CompletedNCT03697304
Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ezabenlimab | 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles. |
| DRUG | BI 754111 | 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles. |
| DRUG | BI 836880 | 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles. |
Timeline
- Start date
- 2019-03-19
- Primary completion
- 2024-12-03
- Completion
- 2024-12-03
- First posted
- 2018-10-05
- Last updated
- 2026-01-27
- Results posted
- 2026-01-27
Locations
17 sites across 3 countries: United States, Canada, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03697304. Inclusion in this directory is not an endorsement.