Trial Outcomes & Findings for Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence (NCT NCT04013672)
NCT ID: NCT04013672
Last Updated: 2024-08-28
Results Overview
Assess clinical activity of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma using PFS at 6 months (PFS-6)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 months from start of treatment
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
Arm A - Have Not Received Immunotherapy
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
0
|
|
Overall Study
COMPLETED
|
32
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Arm A - Have Not Received Immunotherapy
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
0
|
Baseline Characteristics
Only 40 analyzed for this measure for MGMT\_Methylation
Baseline characteristics by cohort
| Measure |
Arm A - Have Not Received Immunotherapy
n=41 Participants
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29
|
1 Participants
n=41 Participants
|
—
|
1 Participants
n=41 Participants
|
|
Age, Customized
30-39
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=41 Participants
|
|
Age, Customized
40-49
|
5 Participants
n=41 Participants
|
—
|
5 Participants
n=41 Participants
|
|
Age, Customized
50-59
|
15 Participants
n=41 Participants
|
—
|
15 Participants
n=41 Participants
|
|
Age, Customized
60-69
|
11 Participants
n=41 Participants
|
—
|
11 Participants
n=41 Participants
|
|
Age, Customized
70-79
|
6 Participants
n=41 Participants
|
—
|
6 Participants
n=41 Participants
|
|
Age, Customized
80-89
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
—
|
18 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=41 Participants
|
—
|
23 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
—
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=41 Participants
|
—
|
37 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=41 Participants
|
—
|
38 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=41 Participants
|
|
MGMT_Methylation
No
|
24 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
—
|
24 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
|
MGMT_Methylation
Unknown
|
1 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
—
|
1 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
|
MGMT_Methylation
Yes
|
15 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
—
|
15 Participants
n=40 Participants • Only 40 analyzed for this measure for MGMT\_Methylation
|
|
Number_of_Prior_Surgeries
1
|
31 Participants
n=41 Participants
|
—
|
31 Participants
n=41 Participants
|
|
Number_of_Prior_Surgeries
2
|
9 Participants
n=41 Participants
|
—
|
9 Participants
n=41 Participants
|
|
Number_of_Prior_Surgeries
3
|
1 Participants
n=41 Participants
|
—
|
1 Participants
n=41 Participants
|
|
Temodar_with_Radiation__Concurre
No
|
5 Participants
n=41 Participants
|
—
|
5 Participants
n=41 Participants
|
|
Temodar_with_Radiation__Concurre
Yes
|
36 Participants
n=41 Participants
|
—
|
36 Participants
n=41 Participants
|
|
kps_bs
70
|
9 Participants
n=41 Participants
|
—
|
9 Participants
n=41 Participants
|
|
kps_bs
80
|
19 Participants
n=41 Participants
|
—
|
19 Participants
n=41 Participants
|
|
kps_bs
90
|
13 Participants
n=41 Participants
|
—
|
13 Participants
n=41 Participants
|
|
Temodar_Alone__Adjuvant__
No
|
8 Participants
n=41 Participants
|
—
|
8 Participants
n=41 Participants
|
|
Temodar_Alone__Adjuvant__
Yes
|
33 Participants
n=41 Participants
|
—
|
33 Participants
n=41 Participants
|
|
Clinical_Trial_given_drugs
No/Unknown
|
19 Participants
n=41 Participants
|
—
|
19 Participants
n=41 Participants
|
|
Clinical_Trial_given_drugs
Yes
|
22 Participants
n=41 Participants
|
—
|
22 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 6 months from start of treatmentPopulation: Exploratory arm was not conducted
Assess clinical activity of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma using PFS at 6 months (PFS-6)
Outcome measures
| Measure |
Arm A - Have Not Received Immunotherapy
n=41 Participants
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Progression Free Survival (PFS)
|
34.5 percentage of participants
Interval 19.8 to 49.6
|
—
|
SECONDARY outcome
Timeframe: up to 1 year from enrollmentPopulation: Exploratory arm was not conducted
Safety and tolerability of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma measured on ongoing basis with CTCAE v 5 grading as per NCI. Grade 1-2 and 3-5 events will be recorded and reported.
Outcome measures
| Measure |
Arm A - Have Not Received Immunotherapy
n=41 Participants
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Number of CTCAE V5 Events with Grades 1-2
|
481 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Number of CTCAE V5 Events with Grades 3-5
|
107 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Possible AEs related to Pembrolizumab
|
43 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Probable AEs related to Pembrolizumab
|
6 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unlikely AEs related to Pembrolizumab
|
31 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unrelated AEs to Pembrolizumab
|
508 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Definite AEs related to SurVaxM
|
6 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Possible AEs related to SurVaxM
|
25 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Probable AEs related to SurVaxM
|
38 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unlikely AEs related to SurVaxM
|
67 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unrelated AEs to SurVaxM
|
452 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Definite AEs related to disease
|
39 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Possible AEs related to disease
|
90 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Probable AEs related to disease
|
104 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unlikely AEs related to disease
|
43 Events
|
—
|
|
Safety and Tolerability of Pembrolizumab and SurVaxM as Measure by CTCAE v 5 Grading as Per NCI
Unrelated AEs to disease
|
312 Events
|
—
|
Adverse Events
Arm A - Have Not Received Immunotherapy
Serious events: 22 serious events
Other events: 41 other events
Deaths: 1 deaths
Arm B - Have Failed Prior Anti-PD1 Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Have Not Received Immunotherapy
n=41 participants at risk
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Endocrine disorders
Adrenal insufficiency
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Endocrine disorders
Hypophysitis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
Dysphagia
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Chills
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Disease progression
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Edema limbs
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Fatigue
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Fever
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Gait disturbance
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Injection site reaction
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
Multi-organ failure
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Injury, poisoning and procedural complications
Fall
|
12.2%
5/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
Platelet count decreased
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Cognitive disturbance
|
12.2%
5/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Dysarthria
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Dysphasia
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Edema cerebral
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Facial muscle weakness
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Lethargy
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Muscle weakness left-sided
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Seizure
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Somnolence
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Agitation
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Anxiety
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Confusion
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
Personality change
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Vascular disorders
Thromboembolic event
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
Other adverse events
| Measure |
Arm A - Have Not Received Immunotherapy
n=41 participants at risk
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
Arm B - Have Failed Prior Anti-PD1 Therapy
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Pembrolizumab: 200 mg IV every 3 weeks
SurVaxM: 500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Sargramostim: 100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
Montanide ISA 51: 1 ml per dose dosed every two weeks for 4 doses and then every 3 months
|
|---|---|---|
|
Investigations
alt increased
|
19.5%
8/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
anc decreased
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
anc increased
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
anemia
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
leukocytosis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
platelet decreased
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
wbc decreased
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
wbc increased
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
angina
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
cardiac arrest
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
facial flushing
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
hypertension
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
hypotension
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
palpitations
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
pulmonary embolism
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
tachycardia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Cardiac disorders
thrombocytosis
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Ear and labyrinth disorders
ear pain
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Ear and labyrinth disorders
hearing loss
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Ear and labyrinth disorders
vertigo
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
decreased t3
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
decreased t4
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
decreased tsh
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
hyperthyroidism
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
hypophysitis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
hypothyroidism
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
increased t4
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
increased tsh
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
blurry vision
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
cataracts
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
decreased depth perception
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
diplopia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
eye irritation
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
peripheral vision
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Eye disorders
photophobia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
blisters lip
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
chills
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
cough
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
decreased appetite
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
dry mouth
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
extravastion
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
extremity pain
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
face edema
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
falls
|
43.9%
18/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
fatigue
|
41.5%
17/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
fever
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
flu symptoms
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
generalized edema
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
heat intolerance
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
infection
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
insomnia
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
lethargy
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
limbs edema
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
oral
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
other
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
pain
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
rib pain
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
General disorders
weight loss
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
abdominal bloating
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
canker sore (mouth pain)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
checkpoint inhibitor hepatitis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
constipation
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
diarrhea
|
19.5%
8/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
dysphagia
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
gas (belching)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
gerd
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
investigations
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
nausea
|
19.5%
8/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Gastrointestinal disorders
vomiting
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Infections and infestations
infection of unknown etiology
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Infections and infestations
lung infection
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Infections and infestations
possible sepsis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
abnormal electrocytes
|
19.5%
8/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
adrenal insufficiency
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
alkaline phosphatase increased
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
allergic reaction
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
ast increased
|
22.0%
9/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
bruising (generalized)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
death
|
19.5%
8/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
hyperglycemia
|
14.6%
6/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
multisystem organ failure
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Investigations
other
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Metabolism and nutrition disorders
decreased appetite
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Metabolism and nutrition disorders
decreased phosphorus
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
ankle swelling
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
back pain
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
decreased mobility
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
extremity pain
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
53.7%
22/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Musculoskeletal and connective tissue disorders
paresthesia
|
34.1%
14/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasms benign or malignant
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
altered sense of smell
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
aphasia
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
cerebral edema
|
17.1%
7/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
cognitive disturbance
|
46.3%
19/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
decreased consciousness
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
dizziness
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
edema cerebral
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
fine motor skills change
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
headache
|
43.9%
18/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
intermittent metallic taste
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
memory loss
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
mental or emotional change
|
34.1%
14/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
numbness
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
paresthesia
|
34.1%
14/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
seizure
|
26.8%
11/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
sensation changes
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
spasticity
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
speech changes
|
4.9%
2/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Nervous system disorders
tremor
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
cpk increased
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
creatinine increased
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
glucosuria
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
hemaglobinuria
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
proteinuria
|
43.9%
18/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
urinary frequency change
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
urinary s/s
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
urinary tract infection
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Renal and urinary disorders
urinary urgency
|
7.3%
3/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis (nose bleed)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
laryngeal inflammation
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion (left)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
rhinnorhea
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Respiratory, thoracic and mediastinal disorders
throat mucous (postnasal drip)
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
dry skin
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
generalized rash
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
46.3%
19/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
night sweats
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
photosensitivity
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
pruritus
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
rash
|
9.8%
4/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
|
Skin and subcutaneous tissue disorders
swelling at craniotomy site
|
2.4%
1/41 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
—
0/0 • Day 1 of treatment until 30 days after patient went off study, upto 19.7 months
Exploratory arm was not conducted
|
Additional Information
David Peereboom, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place