18 and older, any sex, with Triple Negative Breast Cancer or Inflammatory Breast Cancer Stage IV. 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.
Objective Response Rate (ORR)Primary· Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
ORR is defined as the percentage of evaluable participants who had at least one confirmed overall response of complete response (CR) or partial response (PR) according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR: Disappearance of all target lesions (TLs) since baseline, any pathological lymph nodes selected as TLs must have a reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percent decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
Group
Value
95% CI
Bemcentinib + Pembrolizumab
0
Disease Control Rate (DCR)Secondary· Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD). CR: Disappearance of all target lesions (TLs) since baseline, any pathological lymph nodes selected as TLs must have a reduction in short axis to \< 10 mm. PR: At least a 30 percent decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. SD per modified RECIST 1.1 defined as: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Group
Value
95% CI
Bemcentinib + Pembrolizumab
3.4
Progression-free Survival (PFS)Secondary· Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
PFS was defined as the duration from start of treatment until the date of radiological disease progression (the date on which the confirmed progression was initially observed) or the date of death (regardless of cause of death), whichever was earlier.
Group
Value
95% CI
Bemcentinib + Pembrolizumab
13.1
12.4 – 18.3
Overall Survival (OS)Secondary· Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
OS was defined as the time from the first dose of study treatment until the date of death (from any cause and irrespective of any subsequent anti-cancer treatment given).
Group
Value
95% CI
Bemcentinib + Pembrolizumab
32.0
13.6 – 37.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Bemcentinib + Pembrolizumab
Serious: 22/29 (76%)
Deaths: 16/29
Serious adverse events (35 terms)
Reaction
System
Bemcentinib + Pembrolizumab
Pyrexia
General disorders
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Transaminases increased
Investigations
—
Rash generalised
Skin and subcutaneous tissue disorders
—
Adverse drug reaction
General disorders
—
Face oedema
General disorders
—
Oedema peripheral
General disorders
—
Pruritus generalised
Skin and subcutaneous tissue disorders
—
Rash
Skin and subcutaneous tissue disorders
—
Urinary tract infection
Infections and infestations
—
Neutropenic sepsis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Septic shock
Infections and infestations
—
Upper respiratory tract infection
Infections and infestations
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Hypovolaemic shock
Vascular disorders
—
Jugular vein thrombosis
Vascular disorders
—
Lymphoedema
Vascular disorders
—
Autoimmune hepatitis
Hepatobiliary disorders
—
Hepatitis acute
Hepatobiliary disorders
—
Other adverse events (121 terms — click to expand)
This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The primary objective is objective response rate.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H
· Phase 3
· recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
· Phase 1
· recruiting
NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
· Phase 1, PHASE2
· recruiting
NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
· NA
· recruiting
Other BerGenBio ASA trials
Trials by the same sponsor.
NCT05469178 — A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell
· Phase 1, PHASE2
· terminated
NCT06469138 — A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
· Phase 1
· completed
NCT04893551 — A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
· Phase 1
· terminated
NCT04890509 — A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
· Phase 2
· completed
NCT03795142 — A First-time-in-human Study of BGB149
· EARLY_PHASE1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BerGenBio ASA
Last refreshed: 9 November 2021
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/NCT03184558.