Trial Outcomes & Findings for A Study Of Pembrolizumab In Combination With Trastuzumab-DM1 (NCT NCT03032107)
NCT ID: NCT03032107
Last Updated: 2025-01-27
Results Overview
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v4.0 will be used to identify a safe and tolerable dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
21 days
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
* All patients were treated at dose level 1: 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Dose De-escalation (Dose-finding)
STARTED
|
6
|
|
Dose De-escalation (Dose-finding)
COMPLETED
|
6
|
|
Dose De-escalation (Dose-finding)
NOT COMPLETED
|
0
|
|
Recommended Phase 2 Dose Expansion
STARTED
|
14
|
|
Recommended Phase 2 Dose Expansion
COMPLETED
|
14
|
|
Recommended Phase 2 Dose Expansion
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Of Pembrolizumab In Combination With Trastuzumab-DM1
Baseline characteristics by cohort
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
* All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 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
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
ECOG at baselin
0
|
14 Participants
n=5 Participants
|
|
ECOG at baselin
1
|
5 Participants
n=5 Participants
|
|
ECOG at baselin
2
|
1 Participants
n=5 Participants
|
|
ER/PR status at initial diagnosis
ER and/or PR positive
|
14 Participants
n=5 Participants
|
|
ER/PR status at initial diagnosis
ER and PR negative
|
6 Participants
n=5 Participants
|
|
Disease-free interval
≤2 years
|
5 Participants
n=5 Participants
|
|
Disease-free interval
>2 years
|
6 Participants
n=5 Participants
|
|
Disease-free interval
Dates missing
|
4 Participants
n=5 Participants
|
|
Disease-free interval
De novo (metastatic disease at primary diagnosis)
|
5 Participants
n=5 Participants
|
|
Lines of chemotherapy for metastatic disease
|
1 Line
n=5 Participants
|
|
Disease sites at trial enrollment - Lymph node
|
13 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Breast/chest wall
|
10 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Lung/pleura
|
9 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Bone
|
9 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Liver
|
4 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Other soft tissue
|
3 Participants
n=5 Participants
|
|
Disease sites at trial enrollment - Central nervous system
|
1 Participants
n=5 Participants
|
|
Prior therapy in any setting - Anthracycline chemotherapy
|
5 Participants
n=5 Participants
|
|
Prior therapy in any setting - Taxane chemotherapy
|
20 Participants
n=5 Participants
|
|
Prior therapy in any setting - Trastuzumab
|
20 Participants
n=5 Participants
|
|
Prior therapy in any setting - Pertuzumab
|
20 Participants
n=5 Participants
|
|
Prior therapy in any setting - T-DM1
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: The analysis population is patients that were enrolled in the dose de-escalation (dose finding) stage.
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE v4.0 will be used to identify a safe and tolerable dose
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=6 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants who have received at least one dose of study medication at the recommended phase 2 dose and had measurable disease were assessed for objective response rate.
Objective Response Rate (ORR) is defined as the percentage of patients with complete or partial response evaluated by RECIST 1.1. Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Objective Response Rate
|
20 percentage of participants
Interval 5.7 to 43.7
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants who have received at least one dose of study medication at the recommended phase 2 dose were assessed for PFS
Progression Free Survival, estimated via Kaplan-Meier method, is defined as the time from study registration to radiographic evidence of disease progression or death due to any cause, whichever occurred first. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients alive without disease progression are censored at the date of last disease evaluation.
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Progression Free Survival
|
9.6 month
Interval 2.8 to 16.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants who have received at least one dose of study medication at the recommended phase 2 dose and had measurable disease were assessed for duration of response
The duration of response, estimated via Kaplan-Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Duration Of Response
|
10.1 month
Interval 3.1 to
Upper limit for the 95% Confidence Interval could not be calculated due to an insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: All participants who have received at least one dose of study medication at the recommended phase 2 dose and had measurable disease were assessed for disease control rate.
Disease Control Rate will be determined by looking at the number of subjects who have either a complete response, partial response, or stable disease for greater than or equal to 18 weeks, per RECIST 1.1
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Disease Control Rate
|
60 percentage of participants
Interval 36.0 to 80.9
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All participants who have received at least one dose of study medication at the recommended phase 2 dose will be assessed for overall survival
OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Outcome measures
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 Participants
--All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Overall Survival Rate
|
NA month
Interval 11.2 to
Median and upper limit for the 95% Confidence Interval could not be calculated due to an insufficient number of participants with events. The 50% survival probability was never reached due to small number of events. If a Kaplan-Meier curve is drawn, the curve will be above the 50% OS probability line. So no estimation could be made for median and the upper limit of confidence interval.
|
Adverse Events
Pembrolizumab Combine With Trastuzumab Emtansine
Serious events: 2 serious events
Other events: 20 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 participants at risk
* All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
Other adverse events
| Measure |
Pembrolizumab Combine With Trastuzumab Emtansine
n=20 participants at risk
* All patients received 200mg Pembro + 3.6mg/kg T-DM1
* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
* Pembrolizumab will be administered prior to T-DM1 administration
* Pembrolizumab will be given at a predetermine dose
* T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
* T-DM1 will be given at a predetermine dose
T-DM1: -T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab: -Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
15.0%
3/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Cardiac disorders
Heart failure
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Eye disorders
Blurred vision
|
15.0%
3/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Eye disorders
Watering eyes
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Nausea
|
55.0%
11/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Chills
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Edema limbs
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Fatigue
|
80.0%
16/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Fever
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Flu like symptoms
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Irritability
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
General disorders
Pain
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Bladder infection
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Papulopustular rash
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
6/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
8/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Investigations - Other, specify
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
Platelet count decreased
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.0%
7/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
6/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
4/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
3/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
10.0%
2/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • AE data were collected every cycle from the time of the first dose of the study treatment, through the end of the treatment. Vital status was followed even after patients were off treatment. All-Cause Mortality was assessed up to 5 years, and all adverse events were collected up to 44 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place