Trial Outcomes & Findings for Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma (NCT NCT03197506)
NCT ID: NCT03197506
Last Updated: 2026-03-25
Results Overview
A dose limiting toxicity DLT will be defined as an adverse event attributed (definitely, probably, or possibly) to pembrolizumab per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Criteria: Grade 4 or higher neutropenia last at least 7 days. Grade 3 electrolyte alteration, nausea, vomiting, or diarrhea lasting at least 3 days. Grade 3 or higher neurologic toxicity. Toxicities leading to delayed treatment of at least 14 days. Inability to proceed to planned surgical resection. Inability to receive at least 75 percent of cumulative radiation dose.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
189 days
Results posted on
2026-03-25
Participant Flow
Participant milestones
| Measure |
Group 1 Dose Level 1 Cohort 1
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
4
|
37
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group 1 Dose Level 1 Cohort 1
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
Baseline characteristics by cohort
| Measure |
Group 1 Dose Level 1
n=3 Participants
NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1.\>
\> SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.\>
\> CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.\>
\> ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 2
n=4 Participants
EOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1.\>
\> SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.\>
\> CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.\>
\> ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 3
n=4 Participants
EOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1.\>
\> SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.\>
\> CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.\>
\> ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 4
n=4 Participants
EOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1.\>
\> SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.\>
\> CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.\>
\> ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 2 (Pembrolizumab, Temozolomide, Radiation Therapy )
n=36 Participants
CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.\>
\> ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 7.8 • n=138 Participants
|
37.5 years
STANDARD_DEVIATION 7.5 • n=62 Participants
|
50.3 years
STANDARD_DEVIATION 19.2 • n=123 Participants
|
48.8 years
STANDARD_DEVIATION 18.7 • n=158 Participants
|
57.2 years
STANDARD_DEVIATION 10.0 • n=88 Participants
|
54.5 years
STANDARD_DEVIATION 12.3 • n=1 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
9 Participants
n=88 Participants
|
18 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
27 Participants
n=88 Participants
|
33 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
2 Participants
n=88 Participants
|
2 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
4 Participants
n=158 Participants
|
34 Participants
n=88 Participants
|
49 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
2 Participants
n=88 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
4 Participants
n=158 Participants
|
32 Participants
n=88 Participants
|
47 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 189 daysPopulation: Only group 1 patients evaluable for MTD determination are included in this analysis.
A dose limiting toxicity DLT will be defined as an adverse event attributed (definitely, probably, or possibly) to pembrolizumab per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Criteria: Grade 4 or higher neutropenia last at least 7 days. Grade 3 electrolyte alteration, nausea, vomiting, or diarrhea lasting at least 3 days. Grade 3 or higher neurologic toxicity. Toxicities leading to delayed treatment of at least 14 days. Inability to proceed to planned surgical resection. Inability to receive at least 75 percent of cumulative radiation dose.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=3 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
n=3 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
n=3 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
n=3 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Incidence of Dose Limiting Toxicities
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The first 33 evaluable patients are included in this analysis.
Defined as the number of patients who are alive up to 18 months after beginning study therapy.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=33 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Group 2 Overall Survival (OS) at 18 Months
|
19 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 monthsThe overall count of participants that reported Grade 3 or higher adverse events considered at least possibly related to treatment will be calculated and reported in this section. The number of all adverse events will be tabulated and summarized in the adverse events section of this report. Group 1 dose levels are combined due to scientific interest being in the comparison of group 1, the neoadjuvant group, to group 2, the adjuvant group. Per protocol this exploratory and hypothesis generating endpoint may be analyzed by group. All patients that received the same dose level of treatment are combined to better show the adverse events encountered by the treatment population.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=15 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
n=36 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
6 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 monthsDefined as the time from treatment start date to the date of the patients first grade 3 or higher event deemed related to treatment. Group 1 dose levels are combined due to scientific interest being in the comparison of group 1, the neoadjuvant group, to group 2, the adjuvant group. Per protocol this exploratory and hypothesis generating endpoint may be analyzed by group. All patients that received the same dose level of treatment are combined to better show the adverse events encountered by the treatment population.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=15 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
n=36 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Time Until Treatment Related Grade 3+ Adverse Event
|
NA Months
Interval 3.7 to
Too few events occurred to calculate median and upper CI
|
6.9 Months
Interval 4.7 to
Too few events occurred to calculate upper CI
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be summarized descriptively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsWill assess the time until hematologic nadirs (white blood cell count, absolute neutrophil count, platelets) and will be summarized descriptively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsDefined as the time from start of study treatment to disease progression. Will be assessed using the immunotherapy response assessment for neuro-oncology (iRANO) criteria.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=36 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Time to Progression (Group 2)
|
10.7 Months
Interval 8.0 to 12.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 monthsDefined as the time from starting study treatment to the date of disease progression or death resulting from any cause, whichever comes first. Will be assessed according to iRANO criteria.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=36 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Progression-free Survival (Group 2)
|
10.7 Months
Interval 8.0 to 12.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 13 monthsDefined as the time from beginning study therapy to documentation of disease progression, unacceptable adverse event(s), or refusal to continue participation by the patient.
Outcome measures
| Measure |
Group 1 Dose Level 1 Cohort 1
n=36 Participants
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|
|
Time to Treatment Failure (Group 2)
|
8.3 Months
Interval 6.1 to 10.9
|
—
|
—
|
—
|
Adverse Events
Group 1 Dose Level 1 Cohort 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Group 1 Dose Level 1 Cohort 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Group 1 Dose Level 1 Cohort 3
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Group 1 Dose Level 1 Cohort 4
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Group 2
Serious events: 18 serious events
Other events: 34 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Group 1 Dose Level 1 Cohort 1
n=3 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 2
n=36 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
8.3%
3/36 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
8.3%
3/36 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
8.3%
3/36 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Vascular disorders
Thromboembolic event
|
66.7%
2/3 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
8.3%
3/36 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
Other adverse events
| Measure |
Group 1 Dose Level 1 Cohort 1
n=3 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 2
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 3
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 1 Dose Level 1 Cohort 4
n=4 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
Group 2
n=36 participants at risk
NEOADJUVANT (CYCLE 1): Patients receive 200mg pembrolizumab IV over 30 minutes on day 1.
SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7.
CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 75mg/m\^2 temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54.
ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive 200mg pembrolizumab IV over 30 minutes on days 1, 22, and 43 and 150mg/m\^2 temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
|
|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 5 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
66.7%
24/36 • Number of events 47 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
22.2%
8/36 • Number of events 14 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 5 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
100.0%
4/4 • Number of events 13 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 8 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
47.2%
17/36 • Number of events 38 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
9/36 • Number of events 18 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 8 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 14 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
100.0%
4/4 • Number of events 23 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
100.0%
4/4 • Number of events 13 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
83.3%
30/36 • Number of events 116 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
30.6%
11/36 • Number of events 18 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
100.0%
4/4 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 11 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
63.9%
23/36 • Number of events 60 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
13.9%
5/36 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 9 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
30.6%
11/36 • Number of events 23 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
13.9%
5/36 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
19.4%
7/36 • Number of events 21 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Cognitive disturbance
|
66.7%
2/3 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
18/36 • Number of events 44 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 7 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
5.6%
2/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Dysphasia
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
9/36 • Number of events 20 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Facial muscle weakness
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
13.9%
5/36 • Number of events 11 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 8 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 12 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 7 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
55.6%
20/36 • Number of events 50 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
100.0%
3/3 • Number of events 7 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Pyramidal tract syndrome
|
33.3%
1/3 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
8.3%
3/36 • Number of events 12 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 6 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
9/36 • Number of events 18 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
25.0%
1/4 • Number of events 2 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/36 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
0.00%
0/4 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
2.8%
1/36 • Number of events 1 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
3/3 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
50.0%
2/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
75.0%
3/4 • Number of events 3 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
30.6%
11/36 • Number of events 17 • Adverse events were folllowed for 14 months and mortality was followed for 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place