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NCT03697304

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

Completed Phase 2 Results posted Last updated 27 January 2026
What this trial tests

Phase 2 trial testing Ezabenlimab in Neoplasm Metastasis in 211 participants. Completed in 3 December 2024.

Timeline
19 March 2019
Primary endpoint
3 December 2024
3 December 2024

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment211
Start date19 March 2019
Primary completion3 December 2024
Estimated completion3 December 2024
Sites17 locations across United Kingdom, Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Neoplasm Metastasis or Advanced Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

[Module C] Duration of Response (DoR) Secondary · From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 174.6 weeks.

Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), 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 reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on

GroupValue95% CI
Module C, Cohort 1: GEC Patients105.9512.3 – 174.6
Module C, Cohort 2: 2ary Resistance Patients30.906.4 – 81.3
Module C, Cohort 3: 1ary Resistance Patients8.508.4 – 8.6
Module C, Cohort 4: CRC Patients25.0012.1 – 37.9
Module C, Cohort 5: EC Patients47.306.1 – 143.1
[Module C] Disease Control (DC) Secondary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.

Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD)

GroupValue95% CI
Module C, Cohort 1: GEC Patients57.137.2 – 75.5
Module C, Cohort 2: 2ary Resistance Patients73.354.1 – 87.7
Module C, Cohort 3: 1ary Resistance Patients42.924.5 – 62.8
Module C, Cohort 4: CRC Patients56.737.4 – 74.5
Module C, Cohort 5: EC Patients77.852.4 – 93.6
[Module C] Disease Control (DC) - Bayesian Hierarchical Model Secondary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.

Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pro

GroupValue95% CI
Module C, Cohort 1: GEC PatientsNANA – NA
Module C, Cohort 2: 2ary Resistance PatientsNANA – NA
Module C, Cohort 3: 1ary Resistance PatientsNANA – NA
Module C, Cohort 4: CRC PatientsNANA – NA
Module C, Cohort 5: EC PatientsNANA – NA
[Module C] Progression-free Survival (PFS) Secondary · From first drug administration until PD or death, whichever occurred earlier. Up to approximately 186.1 weeks.

Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation.

GroupValue95% CI
Module C, Cohort 1: GEC Patients13.46.1 – 33.7
Module C, Cohort 2: 2ary Resistance Patients29.113.0 – 48.7
Module C, Cohort 3: 1ary Resistance Patients6.15.7 – 12.1
Module C, Cohort 4: CRC Patients12.66.1 – 23.6
Module C, Cohort 5: EC Patients75.024.9 – NA
[Module A] Duration of Response (DoR) Secondary · From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 63.6 weeks.

Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), 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 reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on

GroupValue95% CI
Module A, Cohort 2: 2ary Resistance Patients12.305.7 – 31.4
Module A, Cohort 3: 1ary Resistance Patients28.300.1 – 63.6
[Module A] Disease Control (DC) Secondary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.

Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD)

GroupValue95% CI
Module A, Cohort 1: GEC Patients00.0 – 84.2
Module A, Cohort 2: 2ary Resistance Patients42.425.5 – 60.8
Module A, Cohort 3: 1ary Resistance Patients45.229.8 – 61.3
[Module A] Disease Control (DC) - Bayesian Hierarchical Model Secondary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.

Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pro

GroupValue95% CI
Module A, Cohort 1: GEC PatientsNANA – NA
Module A, Cohort 2: 2ary Resistance PatientsNANA – NA
Module A, Cohort 3: 1ary Resistance PatientsNANA – NA
[Module A] Progression-free Survival (PFS) Secondary · From first drug administration until PD, death, or cut-off date of July 2021, whichever occurred earlier. Up to approximately 104.7 weeks.

Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation. Progression free survival was collected, according to the clinical trial protocol until July 2021.

GroupValue95% CI
Module A, Cohort 1: GEC Patients5.95.7 – NA
Module A, Cohort 2: 2ary Resistance Patients6.75.9 – 11.9
Module A, Cohort 3: 1ary Resistance Patients8.95.7 – 16.9
[Module C] Objective Response (OR) Primary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.

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 reference.

GroupValue95% CI
Module C, Cohort 1: GEC Patients14.34.0 – 32.7
Module C, Cohort 2: 2ary Resistance Patients23.39.9 – 42.3
Module C, Cohort 3: 1ary Resistance Patients0.00.0 – 12.3
Module C, Cohort 4: CRC Patients3.30.1 – 17.2
Module C, Cohort 5: EC Patients44.421.5 – 69.2
[Module C] Objective Response (OR) - Bayesian Hierarchical Model Primary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.

Confirmed objective response (OR), defined as the objective response rate (ORR) 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 reference. The estimated objective response rate is presented by the posterior med

GroupValue95% CI
Module C, Cohort 1: GEC PatientsNANA – NA
Module C, Cohort 2: 2ary Resistance PatientsNANA – NA
Module C, Cohort 3: 1ary Resistance PatientsNANA – NA
Module C, Cohort 4: CRC PatientsNANA – NA
Module C, Cohort 5: EC PatientsNANA – NA
[Module A] Objective Response (OR) Primary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.

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 reference.

GroupValue95% CI
Module A, Cohort 1: GEC Patients0.00.0 – 84.2
Module A, Cohort 2: 2ary Resistance Patients6.10.7 – 20.2
Module A, Cohort 3: 1ary Resistance Patients9.52.7 – 22.6
[Module A] Objective Response (OR) - Bayesian Hierarchical Model Primary · From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.

Confirmed objective response (OR), defined as the objective response rate (ORR) 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 reference. The estimated objective response rate is presented by the posterior med

GroupValue95% CI
Module A, Cohort 1: GEC PatientsNANA – NA
Module A, Cohort 2: 2ary Resistance PatientsNANA – NA
Module A, Cohort 3: 1ary Resistance PatientsNANA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Module C, Cohort 1: GEC Patients
Serious: 11/28 (39%)
Deaths: 24/28
Module C, Cohort 2: 2ary Resistance Patients
Serious: 18/30 (60%)
Deaths: 20/30
Module C, Cohort 3: 1ary Resistance Patients
Serious: 12/28 (43%)
Deaths: 22/28
Module C, Cohort 4: CRC Patients
Serious: 13/30 (43%)
Deaths: 17/30
Module C, Cohort 5: EC Patients
Serious: 11/18 (61%)
Deaths: 4/18
Module A, Cohort 1: GEC Patients
Serious: 1/2 (50%)
Deaths: 0/2
Module A, Cohort 2: 2ary Resistance Patients
Serious: 13/33 (39%)
Deaths: 29/33
Module A, Cohort 3: 1ary Resistance Patients
Serious: 12/42 (29%)
Deaths: 32/42

Serious adverse events (105 terms)

ReactionSystemModule C, Cohort 1: GEC Pa…Module C, Cohort 2: 2ary R…Module C, Cohort 3: 1ary R…Module C, Cohort 4: CRC Pa…Module C, Cohort 5: EC Pat…Module A, Cohort 1: GEC Pa…Module A, Cohort 2: 2ary R…Module A, Cohort 3: 1ary R…
DEEP VEIN THROMBOSISVASCULAR DISORDERS
ASCITESGASTROINTESTINAL DISORDERS
OESOPHAGEAL PERFORATIONGASTROINTESTINAL DISORDERS
SMALL INTESTINAL OBSTRUCTIONGASTROINTESTINAL DISORDERS
PAINGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PNEUMONIA ASPIRATIONINFECTIONS AND INFESTATIONS
URINARY TRACT INFECTIONINFECTIONS AND INFESTATIONS
FALLINJURY, POISONING AND PROCEDURAL COMPLICATIONS
ASPIRATIONRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSIONRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PNEUMOTHORAXRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HYPERTENSIONVASCULAR DISORDERS
ANAEMIABLOOD AND LYMPHATIC SYSTEM DISORDERS
BANDAEMIABLOOD AND LYMPHATIC SYSTEM DISORDERS
IMMUNE THROMBOCYTOPENIABLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIABLOOD AND LYMPHATIC SYSTEM DISORDERS
ACUTE LEFT VENTRICULAR FAILURECARDIAC DISORDERS
ACUTE MYOCARDIAL INFARCTIONCARDIAC DISORDERS
ATRIAL FIBRILLATIONCARDIAC DISORDERS
ATRIOVENTRICULAR BLOCK COMPLETECARDIAC DISORDERS
CARDIAC ARRESTCARDIAC DISORDERS
MYOCARDITISCARDIAC DISORDERS
PERICARDIAL EFFUSIONCARDIAC DISORDERS
SUPRAVENTRICULAR TACHYCARDIACARDIAC DISORDERS
ADRENAL INSUFFICIENCYENDOCRINE DISORDERS
Other adverse events (153 terms — click to expand)

ReactionSystemModule C, Cohort 1: GEC Pa…Module C, Cohort 2: 2ary R…Module C, Cohort 3: 1ary R…Module C, Cohort 4: CRC Pa…Module C, Cohort 5: EC Pat…Module A, Cohort 1: GEC Pa…Module A, Cohort 2: 2ary R…Module A, Cohort 3: 1ary R…
FATIGUEGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
WEIGHT DECREASEDINVESTIGATIONS
NAUSEAGASTROINTESTINAL DISORDERS
OEDEMA PERIPHERALGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CONSTIPATIONGASTROINTESTINAL DISORDERS
VOMITINGGASTROINTESTINAL DISORDERS
COUGHRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DIARRHOEAGASTROINTESTINAL DISORDERS
DECREASED APPETITEMETABOLISM AND NUTRITION DISORDERS
HYPERTENSIONVASCULAR DISORDERS
ABDOMINAL PAINGASTROINTESTINAL DISORDERS
ARTHRALGIAMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
HYPOTHYROIDISMENDOCRINE DISORDERS
DEHYDRATIONMETABOLISM AND NUTRITION DISORDERS
ANAEMIABLOOD AND LYMPHATIC SYSTEM DISORDERS
URINARY TRACT INFECTIONINFECTIONS AND INFESTATIONS
BLOOD CREATININE INCREASEDINVESTIGATIONS
BACK PAINMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
DIZZINESSNERVOUS SYSTEM DISORDERS
HEADACHENERVOUS SYSTEM DISORDERS
DYSPNOEARESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HYPOTENSIONVASCULAR DISORDERS
PYREXIAGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
UPPER RESPIRATORY TRACT INFECTIONINFECTIONS AND INFESTATIONS
BLOOD ALKALINE PHOSPHATASE INCREASEDINVESTIGATIONS
HYPOKALAEMIAMETABOLISM AND NUTRITION DISORDERS
PROTEINURIARENAL AND URINARY DISORDERS
PRURITUSSKIN AND SUBCUTANEOUS TISSUE DISORDERS
CHILLSGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
COVID-19INFECTIONS AND INFESTATIONS
PNEUMONIAINFECTIONS AND INFESTATIONS
INFUSION RELATED REACTIONINJURY, POISONING AND PROCEDURAL COMPLICATIONS
ASPARTATE AMINOTRANSFERASE INCREASEDINVESTIGATIONS
PLATELET COUNT DECREASEDINVESTIGATIONS
HYPERCALCAEMIAMETABOLISM AND NUTRITION DISORDERS
HYPERURICAEMIAMETABOLISM AND NUTRITION DISORDERS
FLANK PAINMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMSMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
NECK PAINMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITYMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Most-reported serious reactions: DEEP VEIN THROMBOSIS, ASCITES, OESOPHAGEAL PERFORATION, SMALL INTESTINAL OBSTRUCTION, PAIN, PNEUMONIA ASPIRATION, URINARY TRACT INFECTION, FALL.

Data from ClinicalTrials.gov NCT03697304 adverse events section.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel immune checkpoint targets: moving beyond PD-1 and CTLA-4.
    Qin S, Xu L, Yi M, Yu S, et al · · 2019 · cited 909× · PMID 31690319 · DOI 10.1186/s12943-019-1091-2
  2. Next generation of immune checkpoint inhibitors and beyond.
    Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
  3. Emerging new therapeutic antibody derivatives for cancer treatment.
    Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
  4. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
    Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
  5. Immune checkpoint molecules in natural killer cells as potential targets for cancer immunotherapy.
    Cao Y, Wang X, Jin T, Tian Y, et al · · 2020 · cited 133× · PMID 33122640 · DOI 10.1038/s41392-020-00348-8
  6. A comprehensive comparison between camelid nanobodies and single chain variable fragments.
    Asaadi Y, Jouneghani FF, Janani S, Rahbarizadeh F. · · 2021 · cited 123× · PMID 34863296 · DOI 10.1186/s40364-021-00332-6
  7. Future Therapeutic Directions for Smac-Mimetics.
    Morrish E, Brumatti G, Silke J. · · 2020 · cited 108× · PMID 32053868 · DOI 10.3390/cells9020406
  8. Fibrinogen-like protein 1 (FGL1): the next immune checkpoint target.
    Qian W, Zhao M, Wang R, Li H. · · 2021 · cited 96× · PMID 34526102 · DOI 10.1186/s13045-021-01161-8

Verify or expand the search:

Other trials of Ezabenlimab

Trials testing the same drug.

Other recruiting trials for Neoplasm Metastasis

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03697304.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing