Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Lung Neoplasms

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cohort A enrols participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.

Cohort B enrolls participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.

Cohort C enrolls participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.

Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.

Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a PD-1 inhibitor

Bemcentinib; pembrolizumab

This is an open-label, multi-center, single arm, phase II study to assess the anti-tumor activity and safety of bemcentinib when given in combination with pembrolizumab in up to 106 participants with previously treated, advanced adenocarcinoma of the lung. The study will enroll three cohorts of participants with previously treated, advanced adenocarcinoma of the lung: Cohort A will consist of participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind. Cohort B will consist of participants who received a maximum of one prior line of an anti-programmed death receptor (PD)-(L)1 therapy (monotherapy). Cohort C will consist of participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.The primary objective is to assess the anti-tumor activity of bemcentinib and pembrolizumab when given in combination.

Extension to Simon's 2-stage design allowing termination at the end of Stage 1 for either futility or efficacy.

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC

A Phase II Multi Center Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated Advanced Adenocarcinoma of the Lung

Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].

Objective Response Rate includes all participants who have a partial or complete response.

Disease Control Rate includes all participants who have a partial or complete response, or who maintain stable disease.

Duration of response includes participants with a partial or complete response and is measured from the date of response until the cancer progresses (worsens).

PFS is measured from the date of the 1st dose of the 1st cycle until the date of progression (the date on which the progression is initially observed) or the date of death (whichever is earlier).

Time to death is measured from the date of first dose until the date of death or the date the participants is last known to be alive. It includes all participants.

The number of participants with each adverse event will be summarized.

Cmax defined as the maximum observed concentration.

AUC defined as the area under the concentration versus time curve.

T½ defined as the elimination half-life.

Number of participants with clinical laboratory (hematology, including coagulation, urinalysis), vital signs (temperature, systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate), and ECG abnormalities will be reported.

Merck Sharp & Dohme LLC

BerGenBio ASA

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Diseases

Respiratory Tract Diseases

Docetaxel

Tubulin Modulators

Antimitotic Agents

The dose of docetaxel will be 75 mg/m2 given IV every 21 days. The dose of BGB324 will be escalated in a standard 3+3 fashion until a maximum tolerated dose is determined.

BGB324

David E Gerber, MD

This study is being done to evaluate the safety of the investigational study drug, BGB324 when administered in combination with docetaxel, and to establish the maximum tolerated dose.

Lung cancer remains the leading cause of cancer-related deaths worldwide with an estimated incidence of 1.6 million cases resulting in 1.4 million deaths in annually. Non-small-cell lung cancer (NSCLC) represents 80-85% of cases, and adenocarcinoma is the most common histology.2 The majority of NSCLC patients present with advanced or metastatic disease that is not amenable to surgical resection. Platinum-based combination chemotherapy has reached a therapeutic plateau with a median overall survival (OS) of 7.4 to 9.9 months.

BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor that is over-expressed in many metastatic solid tumors and has been identified as a marker of a poor prognosis in patients with non-small cell lung cancer (NSCLC).

Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.

Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)

Determine and recommended the Phase 2 dose of BGB324 administered with the standard dose of docetaxel in patients in NSCLC by pharmacodynamics and pharmacokinetic assessments.

Texas Tech University Health Sciences Center

University of Texas Southwestern Medical Center

Professor, Internal Medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

Participants received Bemcentinib (BGB324) capsules orally once daily as a loading dose of 400 milligram (mg) on Days 1, 2, and 3. A dose of 200 mg pembrolizumab was given by intravenous infusion over 30 minutes every 3 weeks in all participants. Dosing of both drugs commenced on Day 1. On days when both BGB324 and pembrolizumab were given, pembrolizumab was given first and participants were observed for 1 hour after the end of infusion before BGB324 was administered. From Day 4 onward, participants received a daily maintenance dose of 200 mg along with Pembrolizumab 200 mg intravenous (IV) infusion over 30 minutes every 3 weeks until disease progression, until an unacceptable toxicity occurred that required treatment withdrawal or withdrawal of consent or until 106 weeks had passed.

Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a programmed death receptor-1 (PD-1) inhibitor.

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.

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC

A Phase II, Multi Centre Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated, Locally Advanced and Unresectable or Metastatic Triple Negative Breast Cancer (TNBC) or Triple Negative Inflammatory Breast Cancer (TN-IBC)

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.

DOR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression (PD); the end of response should coincide with the date of progression or death from any cause. PD per modified RECIST 1.1 defined as: at least a 20 percent increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

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.

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.

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).

The safety set included all participants who were enrolled in the study and who received at least 1 dose of study product (bemcentinib and/or pembrolizumab).

Bemcentinib + Pembrolizumab

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

The Safety Set included all participants who were enrolled in the study and who received at least 1 dose of study product (BGB324 and/or pembrolizumab).

None of the participants achieved CR or PR. As there were no responses, the study was terminated. It was planned to terminate the trial in favor of the null hypothesis of futility when 5 or fewer responses were observed in 28 participants.

BerGenBio Clinical Team

The Evaluable analysis set (EAS) included all evaluable participants who had received at least 1 combination dose of pembrolizumab and bemcentinib and who had measurable disease at entry, as determined by the investigator site assessment.

Objective Response Rate (ORR)

Analysis performed on participants in EAS who had an objective response. DOR could not be calculated as none of the participants had an objective response.

Duration of Response (DOR)

The evaluable analysis set included all evaluable participants who had received at least 1 combination dose of pembrolizumab and bemcentinib and who had measurable disease at entry, as determined by the investigator site assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC	NCT03184571	Lung Cancer Met... NSCLC Stage IV Adenocarcinoma ...	Bemcentinib; pe...	18 Years -	BerGenBio ASA
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC	NCT03184571	Lung Cancer Met... NSCLC Stage IV Adenocarcinoma ...	Bemcentinib; pe...	18 Years -	BerGenBio ASA
Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.	NCT02922777	Non-Small Cell ...	BGB324 Docetaxel	18 Years -	University of Texas Southwestern Medical Center
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC	NCT03184558	Triple Negative... Inflammatory Br...	Bemcentinib; pe...	18 Years -	BerGenBio ASA

Spots Global Cancer Trial Database for bgb324

Every month we try and update this database with for bgb324 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bgb324

Every month we try and update this database with for bgb324 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bgb324 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.