Trial Outcomes & Findings for Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations (NCT NCT03299088)
NCT ID: NCT03299088
Last Updated: 2025-05-21
Results Overview
The occurrence of toxicities during the first two cycles (i.e. after completion of the lead in cycle and the first cycle where both pembrolizumab and trametinib are administered) will be considered a DLT, if judged by the Investigator to be possibly, probably or definitely related to study drug administration. Adverse events will be summarized descriptively by type and by severity, with number and relative frequency calculated for all non-zero occurrences.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
Escalation Arm A Dose Level 1
Trametinib 1.5 mg PO D1-10, Pembrolizumab 200 mg administered D1 starting with C2, Q21 days
|
Escalation Arm A Dose Level 2
Trametinib 2 mg PO D1-10, Pembrolizumab 200 mg administered D1 starting with C2, Q21 days
|
Escalation Arm B Dose Level 1
Trametinib 1.5 mg PO D1-10 starting with C2, Pembrolizumab 200 mg administered D1, Q21 days
|
Escalation Arm B Dose Level 2
Trametinib 2 mg PO D1-10 starting with C2, Pembrolizumab 200 mg administered D1, Q21 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
Baseline characteristics by cohort
| Measure |
Escalation Arm A Dose Level 1
n=3 Participants
Patients received trametinib 1.5mg QD and Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Dose Level 2
n=6 Participants
Patients received trametinib 2mg QD and Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 1
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 2
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
15 participants
n=15 Participants
|
|
Mutation Status
KRAS G12C
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
|
Mutation Status
KRAS non-G12C
|
1 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Mutation Status
BRAF non-V600E
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Mutation Status
RAS Wild Type
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Smoking Status
Current
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Smoking Status
Former
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=15 Participants
|
|
Smoking Status
Never
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
|
Prior PD1/PDL1 Treatment
Yes
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=15 Participants
|
|
Prior PD1/PDL1 Treatment
No
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=15 Participants
|
|
PD-L1 Expression (TPS 22C3)
0%
|
2 Participants
n=2 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
3 Participants
n=6 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
3 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
2 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
10 Participants
n=14 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
|
PD-L1 Expression (TPS 22C3)
1-49%
|
0 Participants
n=2 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
3 Participants
n=6 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
0 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
0 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
3 Participants
n=14 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
|
PD-L1 Expression (TPS 22C3)
>/= 50%
|
0 Participants
n=2 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
0 Participants
n=6 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
0 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
1 Participants
n=3 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
1 Participants
n=14 Participants • PD-L1 expression testing was not done for subject 002 on Arm A, Dose level 1
|
|
Prior Chemotherapy
Yes
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
15 Participants
n=15 Participants
|
|
Prior Chemotherapy
No
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Prior Immunotherapy
Yes
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
|
Prior Immunotherapy
No
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Overall object is to assess the efficacy of pembrolizumab (MK-3475) when given in combination with trametinib in the proposed sequencing schemes. The data is being reported per Arm as this reflects the difference in the sequencing of Trametinib and Pembrolizumab.
The occurrence of toxicities during the first two cycles (i.e. after completion of the lead in cycle and the first cycle where both pembrolizumab and trametinib are administered) will be considered a DLT, if judged by the Investigator to be possibly, probably or definitely related to study drug administration. Adverse events will be summarized descriptively by type and by severity, with number and relative frequency calculated for all non-zero occurrences.
Outcome measures
| Measure |
Escalation Arm A Dose Level 1
n=3 Participants
Patients received trametinib 1.5mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Dose Level 2
n=6 Participants
Patients received trametinib 2 mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 1
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 2
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Incidence of Dose-limiting Toxicity (DLT) of Pembrolizumab and Trametinib Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0
|
0 DLT
|
1 DLT
|
0 DLT
|
0 DLT
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Secondary objective is to evaluate the clinical efficacy of pembrolizumab (MK-3475) when given in combination with trametinib in the proposed sequencing schemes. The data is being reported per Arm as this reflects the difference in the sequencing of Trametinib and Pembrolizumab.
Association with response rate will be summarized descriptively by presenting the mean, standard deviation (SD), and other characteristics of molecular and immune measures, stratified by response status. Will assess whether one arm has superior ORR, using logistic regression analysis to control for clinical covariates.
Outcome measures
| Measure |
Escalation Arm A Dose Level 1
n=3 Participants
Patients received trametinib 1.5mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Dose Level 2
n=6 Participants
Patients received trametinib 2 mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 1
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 2
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Secondary objective is to evaluate the clinical efficacy of pembrolizumab (MK-3475) when given in combination with trametinib in the proposed sequencing schemes. The data is being reported per Arm as this reflects the difference in the sequencing of Trametinib and Pembrolizumab.
Associations of molecular and immune measures with PFS will be summarized descriptively by stratified Kaplan-Meier curves and, if numbers permit, by proportional hazards models with molecular and immune responses as predictors. Will assess whether one arm has superior PFS, using proportional hazards models to control for clinical covariates.
Outcome measures
| Measure |
Escalation Arm A Dose Level 1
n=3 Participants
Patients received trametinib 1.5mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Dose Level 2
n=6 Participants
Patients received trametinib 2 mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 1
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Dose Level 2
n=3 Participants
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of either 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.79 months
Interval 1.8 to 8.07
|
0 months
Interval 0.0 to 0.0
|
2.08 months
Interval 1.97 to 2.08
|
0 months
Interval 0.0 to 0.0
|
Adverse Events
Escalation Arm A Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Escalation Arm A Level 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Escalation Arm B Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Escalation Arm B Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Escalation Arm A Level 1
n=3 participants at risk
Patients received trametinib 1.5mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Level 2
n=6 participants at risk
Patients received trametinib 2mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Level 1
n=3 participants at risk
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Level 2
n=3 participants at risk
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Eye disorders
Retinal detachment
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Diverticulitis
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
Other adverse events
| Measure |
Escalation Arm A Level 1
n=3 participants at risk
Patients received trametinib 1.5mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm A Level 2
n=6 participants at risk
Patients received trametinib 2mg QD PO on D1-10. Pembrolizumab IV 200 mg IV over 30 minutes was added on day 1 starting with course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Level 1
n=3 participants at risk
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 1.5mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Escalation Arm B Level 2
n=3 participants at risk
Patients administered Pembrolizumab IV 200 mg IV over 30 minutes. Trametinib dose of 2mg QD was given PO on D1-10 starting in course 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
CPK increased
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
4/6 • Number of events 4 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Eye disorders
Retinal detachment
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
|
General disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/6 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
0.00%
0/3 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for each patient starting from the first day of study drug administration (D1) and continuing through 30 days after the last dose of the study drug, an average of 5.4 months.
Treatment related adverse events, all grades.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place