Trial Outcomes & Findings for Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC (NCT NCT03184558)
NCT ID: NCT03184558
Last Updated: 2021-11-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
Results posted on
2021-11-09
Participant Flow
A total of 29 participants were enrolled and received study medication in this study.
Participant milestones
| Measure |
Bemcentinib + Pembrolizumab
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.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Bemcentinib + Pembrolizumab
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
16
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
Baseline characteristics by cohort
| Measure |
Bemcentinib + Pembrolizumab
n=29 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)Population: 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.
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.
Outcome measures
| Measure |
Bemcentinib + Pembrolizumab
n=29 Participants
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.
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)Population: 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.
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.
Outcome measures
| Measure |
Bemcentinib + Pembrolizumab
n=29 Participants
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.
|
|---|---|
|
Disease Control Rate (DCR)
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)Population: 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.
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.
Outcome measures
| Measure |
Bemcentinib + Pembrolizumab
n=29 Participants
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.
|
|---|---|
|
Progression-free Survival (PFS)
|
13.1 Weeks
Interval 12.4 to 18.3
|
SECONDARY outcome
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)Population: 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.
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).
Outcome measures
| Measure |
Bemcentinib + Pembrolizumab
n=29 Participants
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.
|
|---|---|
|
Overall Survival (OS)
|
32.0 Weeks
Interval 13.6 to 37.1
|
Adverse Events
Bemcentinib + Pembrolizumab
Serious events: 22 serious events
Other events: 29 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Bemcentinib + Pembrolizumab
n=29 participants at risk
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.
|
|---|---|
|
General disorders
Pyrexia
|
17.2%
5/29 • Up to 1 year
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).
|
|
General disorders
Adverse drug reaction
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Face oedema
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Oedema peripheral
|
3.4%
1/29 • Up to 1 year
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).
|
|
Investigations
Alanine aminotransferase increased
|
13.8%
4/29 • Up to 1 year
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).
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
4/29 • Up to 1 year
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).
|
|
Investigations
Transaminases increased
|
6.9%
2/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
3/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.9%
2/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Neutropenic sepsis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.3%
3/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Vascular disorders
Hypovolaemic shock
|
3.4%
1/29 • Up to 1 year
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).
|
|
Vascular disorders
Jugular vein thrombosis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Vascular disorders
Lymphoedema
|
3.4%
1/29 • Up to 1 year
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).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Hepatobiliary disorders
Hepatitis acute
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Up to 1 year
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).
|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Cognitive disorder
|
3.4%
1/29 • Up to 1 year
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).
|
|
Psychiatric disorders
Confusional state
|
3.4%
1/29 • Up to 1 year
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).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
5/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.3%
3/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Up to 1 year
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).
|
Other adverse events
| Measure |
Bemcentinib + Pembrolizumab
n=29 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue
|
41.4%
12/29 • Up to 1 year
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).
|
|
General disorders
Pyrexia
|
20.7%
6/29 • Up to 1 year
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).
|
|
General disorders
Pain
|
10.3%
3/29 • Up to 1 year
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).
|
|
General disorders
Oedema peripheral
|
6.9%
2/29 • Up to 1 year
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).
|
|
General disorders
Influenza like illness
|
10.3%
3/29 • Up to 1 year
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).
|
|
General disorders
Axillary pain
|
6.9%
2/29 • Up to 1 year
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).
|
|
General disorders
Chills
|
6.9%
2/29 • Up to 1 year
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).
|
|
General disorders
Face oedema
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
44.8%
13/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Nausea
|
37.9%
11/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Constipation
|
20.7%
6/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Abdominal distension
|
13.8%
4/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
3/29 • Up to 1 year
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).
|
|
Investigations
Aspartate aminotransferase increased
|
31.0%
9/29 • Up to 1 year
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).
|
|
Investigations
Alanine aminotransferase increased
|
24.1%
7/29 • Up to 1 year
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).
|
|
Investigations
Blood alkaline phosphatase increased
|
17.2%
5/29 • Up to 1 year
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).
|
|
Investigations
Electrocardiogram QT prolonged
|
13.8%
4/29 • Up to 1 year
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).
|
|
Investigations
White blood cell count decreased
|
10.3%
3/29 • Up to 1 year
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).
|
|
Investigations
Neutrophil count decreased
|
10.3%
3/29 • Up to 1 year
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).
|
|
Investigations
Platelet count decreased
|
10.3%
3/29 • Up to 1 year
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).
|
|
Investigations
Lymphocyte count decreased
|
6.9%
2/29 • Up to 1 year
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).
|
|
Investigations
Blood creatinine increased
|
6.9%
2/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.2%
5/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.3%
3/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.3%
3/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
10.3%
3/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Anaemia
|
27.6%
8/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
2/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
3/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Tremor
|
10.3%
3/29 • Up to 1 year
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).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.9%
2/29 • Up to 1 year
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).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
2/29 • Up to 1 year
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).
|
|
Infections and infestations
Oral candidiasis
|
17.2%
5/29 • Up to 1 year
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).
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Up to 1 year
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).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.2%
5/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.8%
4/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.9%
2/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Up to 1 year
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).
|
|
Vascular disorders
Hot flush
|
10.3%
3/29 • Up to 1 year
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).
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Up to 1 year
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).
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Up to 1 year
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).
|
|
General disorders
Asthenia
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Suprapubic pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Chest pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Facial pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Odynophagia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Oral pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.4%
1/29 • Up to 1 year
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).
|
|
Investigations
Blood magnesium decreased
|
3.4%
1/29 • Up to 1 year
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).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
3.4%
1/29 • Up to 1 year
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).
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
1/29 • Up to 1 year
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).
|
|
Investigations
Tri-iodothyronine free decreased
|
3.4%
1/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • Up to 1 year
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).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.4%
1/29 • Up to 1 year
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).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.4%
1/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Aphasia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Hemiparaesthesia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Movement disorder
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Neurological symptom
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Nervous system disorders
Sciatica
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Conjunctivitis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Infection
|
3.4%
1/29 • Up to 1 year
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).
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Up to 1 year
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).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Up to 1 year
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).
|
|
Vascular disorders
Jugular vein thrombosis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Vascular disorders
Haematoma
|
3.4%
1/29 • Up to 1 year
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).
|
|
Psychiatric disorders
Affect lability
|
3.4%
1/29 • Up to 1 year
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).
|
|
Psychiatric disorders
Nervousness
|
3.4%
1/29 • Up to 1 year
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).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
3.4%
1/29 • Up to 1 year
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).
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • Up to 1 year
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).
|
|
Renal and urinary disorders
Incontinence
|
3.4%
1/29 • Up to 1 year
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).
|
|
Renal and urinary disorders
Renal impairment
|
3.4%
1/29 • Up to 1 year
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).
|
|
Eye disorders
Eyelid ptosis
|
3.4%
1/29 • Up to 1 year
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).
|
|
Eye disorders
Vision blurred
|
3.4%
1/29 • Up to 1 year
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).
|
|
Ear and labyrinth disorders
Ear pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.4%
1/29 • Up to 1 year
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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
3.4%
1/29 • Up to 1 year
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place