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NCT03697304 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
211
Enrollment target

NCT03697304: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT03697304 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 211 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03697304, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
211 participants
Enrollment target

Study 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.

Primary Outcome

Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as r

Interventions

  • DRUG Ezabenlimab
  • DRUG BI 836880
  • DRUG BI 754111

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2019-03-19
Est. Completion 2024-12-03
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT03697304 record still lists

NCT03697304 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).

The record links to 0 conditions, and to 3 interventions - of which Ezabenlimab is the first listed.

NCT03697304 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03697304 about?

NCT03697304 is a clinical study titled "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". 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 im...

What is the current status of trial NCT03697304?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 211 participants. The study started on 2019-03-19. Estimated completion is 2024-12-03.

What interventions are being tested in trial NCT03697304?

The interventions under investigation include: Ezabenlimab (DRUG), BI 836880 (DRUG), BI 754111 (DRUG).

Who is sponsoring clinical trial NCT03697304?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03697304's enrollment target sits among peer trials

211 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03697304, the US trial registry maintained by the National Library of Medicine. NCT03697304 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.