Trial Outcomes & Findings for Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma (NCT NCT03661723)
NCT ID: NCT03661723
Last Updated: 2024-09-19
Results Overview
Per Response Assessment in Neuro-Oncology (RANO) Criteria: * Complete Response (CR): * Disappearance of all enhancing measurable \& non-measurable disease sustained for at least 4 weeks * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * No corticosteroids (or physiologic replacement doses only) * And stable or improved clinically * Partial Response (PR): * \>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; * No progression of non-measurable disease * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * Same or lower dose of corticosteroids compared with baseline scan * And stable or improved clinically Overall Response Rate (ORR) = Frequency of CR + PR within a population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
COH A Safety Lead-In - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH A Phase II @ RP2D (Dose Level 0: 200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH B Safety Lead-In - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
o Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH B PhII @ RP2D (Dose Level 0: 200 mg Pembro + 15 mg/kg Bev Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
o Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
24
|
6
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
24
|
6
|
24
|
Reasons for withdrawal
| Measure |
COH A Safety Lead-In - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH A Phase II @ RP2D (Dose Level 0: 200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH B Safety Lead-In - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
o Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
COH B PhII @ RP2D (Dose Level 0: 200 mg Pembro + 15 mg/kg Bev Every 3 Weeks + 2 Weeks of RT)
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
o Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
o Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks o RT destroys cancer cells using radiation aimed at a cancer from a machine
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
4
|
24
|
4
|
19
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Clinical Deterioration
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
KPS = 70
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
KPS = 80
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
KPS = 90
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Karnofsky performance status (KPS)
KPS = 100
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current Recurrence #
First Relapse
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Current Recurrence #
Second Relapse
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Current Recurrence #
Third Relapse
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Current Recurrence #
Fourth Relapse
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Extent of Resection Prior to Study Enrollment
Gross Total Resection (GTR)
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Extent of Resection Prior to Study Enrollment
Sub-Total Resection (STR)
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Extent of Resection Prior to Study Enrollment
Biopsy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Extent of Resection Prior to Study Enrollment
None
|
11 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Extent of Resection Prior to Study Enrollment
Unknown
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
MGMT Methylation Status
Methylated
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
MGMT Methylation Status
Unmethylated
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
MGMT Methylation Status
Unknown
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
IDH mutation
Present
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
IDH mutation
Absent
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
IDH mutation
Unknown
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Dexamethasone Use @ Time On Study
Receiving Dexamethasone
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Dexamethasone Use @ Time On Study
No Dexamethasone
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Time from Original GBM Diagnosis to Trial Registration
|
13.5 months
n=5 Participants
|
14.5 months
n=7 Participants
|
14 months
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: \# of participants in the analysis population who achieve a complete response (CR) or partial response (PR) using RANO criteria
Per Response Assessment in Neuro-Oncology (RANO) Criteria: * Complete Response (CR): * Disappearance of all enhancing measurable \& non-measurable disease sustained for at least 4 weeks * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * No corticosteroids (or physiologic replacement doses only) * And stable or improved clinically * Partial Response (PR): * \>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; * No progression of non-measurable disease * No new lesions * Stable or improved non-enhancing (T2/FLAIR) lesions * Same or lower dose of corticosteroids compared with baseline scan * And stable or improved clinically Overall Response Rate (ORR) = Frequency of CR + PR within a population.
Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Objective Response Rate (ORR)
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Overall Survival Rate at 6 Months (OS-6)
|
83.3 percentage of participants
Interval 6.5 to 92.7
|
56.7 percentage of participants
Interval 37.3 to 72.1
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Overall Survival Rate at 12 Months (OS-12)
|
40.0 percentage of participants
Interval 22.8 to 56.6
|
16.6 percentage of participants
Interval 6.0 to 31.7
|
SECONDARY outcome
Timeframe: 2 yearsNumber of Participants who Experienced an SAE Deemed At Least Possibly Related to Study Treatment (XRT, pembrolizumab, \&/or bevacizumab)
Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Safety & Tolerability: SAEs Experienced by Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 5 COH B patients were censored for duration of response, as they each withdrew consent to be followed (or initiated a new therapy regimen) right after a scan that showed stable disease.
Each patient's response data is reviewed and the duration of his/her best response determined (in days).
Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=25 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Duration of Response
|
79.5 days
Interval 0.0 to 266.0
|
42.0 days
Interval 0.0 to 168.0
|
SECONDARY outcome
Timeframe: 2 yearsProgression is defined using Radiologic Assessment in Neuro-Oncology (RANO) criteria, as any of the following: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement, on stable or increasing doses of corticosteroids * Any new enhancing measurable lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose * Cohort B: Significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids not felt to be caused by co-morbid events * Clear progression of non-measurable disease * Or failure to return for evaluation as a result of death or deteriorating condition
Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Median Progression Free Survival (PFS)
|
4.2 months
Standard Error 0.4551
|
4.0 months
Standard Error 0.5467
|
SECONDARY outcome
Timeframe: 6 monthsProgression is defined using Radiologic Assessment in Neuro-Oncology (RANO) criteria, as any of the following: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement, on stable or increasing doses of corticosteroids * Any new enhancing measurable lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose * Cohort B: Significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids not felt to be caused by co-morbid events * Clear progression of non-measurable disease * Or failure to return for evaluation as a result of death or deteriorating condition
Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
6-month Progression Free Survival (PFS-6)
|
13.3 percentage of participants
Interval 4.2 to 27.7
|
10.6 percentage of participants
Interval 2.2 to 27.0
|
SECONDARY outcome
Timeframe: Participants were followed for survival until death; survival was followed for a max of 4 years. Other Adverse Events (AEs) were collected from registration through 30 days after last dose (SAEs through 90 days); AEs were followed for a max of 2 years.Outcome measures
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 Participants
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Median Overall Survival (OS)
|
11.8 months
Standard Error 1.0262
|
8.6 months
Standard Error 1.1766
|
Adverse Events
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
Serious events: 14 serious events
Other events: 30 other events
Deaths: 30 deaths
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
Serious events: 11 serious events
Other events: 30 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 participants at risk
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 participants at risk
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Eye disorders
Papilledema
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
General disorders
Fever
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Sepsis
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Dysarthria
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Dysphasia
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Edema cerebral
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Seizure
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Left facial droop
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Psychiatric disorders
Confusion
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Craniotomy revision with hardware removal
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify: Craniotomy for tumor resection
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
Other adverse events
| Measure |
COH A - Dose Level 0 (200 mg Pembro Once Every 3 Weeks + 2 Weeks of RT)
n=30 participants at risk
Inclusive of both Safety Lead-In \& PH II COH A participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
COH B - Dose Level 0 (200 mg Pembro + 15 mg/kg Bev Once Every 3 Weeks + 2 Weeks of RT)
n=30 participants at risk
Inclusive of both Safety Lead-In \& PH II COH B participants, as they were all treated at the same dose:
* Pembrolizumab (200 mg) administered intravenously (IV) once every 3 weeks.
* Bevacizumab or biosimilar (15 mg/kg) administered intravenously (IV) once every 3 weeks
* Re-irradiation (35 Gy) administered 5 days per week for 2 weeks
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Endocrine disorders
Nausea
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
General disorders
Fatigue
|
40.0%
12/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
General disorders
Flu like symptoms
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
General disorders
Gait disturbance
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
16.7%
5/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Skin infection
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Investigations
Lymphocyte count decreased
|
23.3%
7/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Investigations
Weight gain
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
16.7%
5/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Dysphasia
|
26.7%
8/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
16.7%
5/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Headache
|
33.3%
10/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
16.7%
5/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Memory impairment
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Nervous system disorders
Seizure
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Psychiatric disorders
Agitation
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Psychiatric disorders
Confusion
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
26.7%
8/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
10.0%
3/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
|
Vascular disorders
Hypertension
|
13.3%
4/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
20.0%
6/30 • Adverse Events (AEs) were collected from registration through 30 days after last dose. Serious AEs (SAEs) were collected through 90 days after last dose (or 30 days if pt initiated new anticancer therapy). AEs were followed for a max of 2 years on this trial. Participants were followed every 3 months (+/- 1 month) until death for survival. Survival was followed for a max of 4 years on this trial.
An AE is any undesirable sign, symptom or medical condition that develops or worsens in severity after initiating study treatment or any protocol-specified procedure, regardless of attribution. An SAE is any AE at any dose \& regardless of causality that: results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event
|
Additional Information
David A. Reardon, MD (Clinical Director, Center for Neuro-Oncology)
Dana-Farber Cancer Institute
Phone: 617-632-2166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place