Trial Outcomes & Findings for Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT (NCT NCT03007732)
NCT ID: NCT03007732
Last Updated: 2025-12-05
Results Overview
Only participants in cohort 2, who achieve testosterone recovery to non-castrate levels (\>150 ng/dL) at 15 months, will be analyzed for the primary endpoint. The rate of PSA \< nadir + 2 ng/mL at 15 months from the start of radiotherapy and cycle 1, day 1 of pembrolizumab, among participants whose testosterone recovers to non-castrate levels (\>150 ng/dL). The point estimate of the rate of PSA \< nadir + 2 ng/mL will be obtained with its 95% confidence interval for participants by arm in cohort 2. All participants who receive any part of a dose of RT, SD-101 or pembrolizumab will be analyzed for efficacy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Start of treatment and 15 months (approx. 15 months total)
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 1, Arm 2: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. Toll-like receptor 9 (TLR9) agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 1, Arm 2: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. Toll-like receptor 9 (TLR9) agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal from study post randomization but just prior to receiving any treatment
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT
Baseline characteristics by cohort
| Measure |
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 1, Arm 2: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic Sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic Sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years old
n=37 Participants
|
63 years old
n=37 Participants
|
66.8 years old
n=74 Participants
|
72.2 years old
n=267 Participants
|
67.2 years old
n=272 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
5 Participants
n=267 Participants
|
21 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
5 Participants
n=267 Participants
|
21 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
5 Participants
n=267 Participants
|
21 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=37 Participants
|
5 participants
n=37 Participants
|
6 participants
n=74 Participants
|
5 participants
n=267 Participants
|
21 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Start of treatment and 15 months (approx. 15 months total)Only participants in cohort 2, who achieve testosterone recovery to non-castrate levels (\>150 ng/dL) at 15 months, will be analyzed for the primary endpoint. The rate of PSA \< nadir + 2 ng/mL at 15 months from the start of radiotherapy and cycle 1, day 1 of pembrolizumab, among participants whose testosterone recovers to non-castrate levels (\>150 ng/dL). The point estimate of the rate of PSA \< nadir + 2 ng/mL will be obtained with its 95% confidence interval for participants by arm in cohort 2. All participants who receive any part of a dose of RT, SD-101 or pembrolizumab will be analyzed for efficacy.
Outcome measures
| Measure |
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Change Rate of Prostate-specific Antigen (PSA) < Nadir + 2 ng/mL From First Day of Treatment to 15 Months (Cohort 2)
|
100 percentage of participants
Interval 54.1 to 100.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 15 monthsAdverse events occurring on study will be summarized for all participants that received study intervention (including pembrolizumab, SD-101, SBRT to prostate, SBRT to oligometastatic sites) by maximum toxicity grade across study arms.
Outcome measures
| Measure |
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events
Hot flashes, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Hyperglycemia, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Hypertension, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Hypokalemia, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Hypothyroidism, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Alkaline phosphatase increased, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Anemia, Grade 1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Arthralgia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Arthritis, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Aspartate aminotransferase increased, Grade 3
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Blood bilirubin increased, Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Chills, Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Colitis, Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Creatinine increased, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Cystitis noninfective, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Depression, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Diarrhea, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Dry mouth, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Dysphagia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Fatigue, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Fever, Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Flu-like symptoms, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Gynecomastia, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Headache, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Hematuria, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Infusion related reaction, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Localized edema, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Mucositis oral, Grade 1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Musculoskeletal and connective tissue disorder - Other, specify
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Myalgia, Grade 1
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Nausea, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Platelet count decreased, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Proctitis, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Pruritus, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Rash maculo-papular, Grade 3
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Rectal hemorrhage, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Renal and urinary disorders - Other, specify, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Sneezing, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Urinary frequency, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Urinary retention, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Urticaria, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Vomiting, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Weight Gain, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Adrenal Insufficiency, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Acute kidney injury, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events
Alanine aminotransferase increased, Grade 3
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 15 monthsTestosterone-PSA uncoupling is defined as PSA \< 50% baseline and \< 20ng/mL for at least 3 months after testosterone recovers to \>150 ng/dL. In participants with metastatic hormone-sensitive prostate cancer off hormonal therapy, \>90% participants are expected to have PSA increase to \> 50% baseline after 3 months of testosterone recovery. Therefore, the presence of PSA testosterone uncoupling in this study may serve as a surrogate of immunotherapeutic responses induced by pembrolizumab combined with RT (arm 1), or RT with SD-101 (arm 2), if a prolonged PSA \< nadir + 2 ng/mL is not achieved. The point estimate of testosterone-PSA uncoupling rate will be obtained with its 95% confidence interval for each arm in cohort 2.
Outcome measures
| Measure |
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Rate of Testosterone-PSA Uncoupling (Cohort 2)
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
80 percentage of participants
Interval 28.4 to 99.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe time to clinical progression in each study arm in cohort 2 is defined as the time to radiographic progression by Prostate Specific Antigen Working Group-2 (PSAWG2) criteria, time to symptomatic progressive disease, or PSA progression, whichever comes the first. Kaplan-Meier estimate will be obtained for the time to clinical progression in each study arm in cohort 2
Outcome measures
| Measure |
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Median Time to Clinical Progression (Cohort 2)
|
NA months
Interval 23.5 to
There was an insufficient number of events therefore a median and upper limit could not be calculated
|
25.4 months
Interval 19.8 to
There was an insufficient number of events therefore an upper limit could not be calculated
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsProgression-free survival (PFS) will be estimated for each study arm on cohort 2 by Kaplan-Meier estimate, where PFS is a composite endpoint based on PSA progression, radiological progression, clinical deterioration, or death.
Outcome measures
| Measure |
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 Participants
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Median Progression-free Survival (PFS) (Cohort 2)
|
NA months
Interval 23.5 to
There was an insufficient number of events therefore a median and upper limit could not be calculated
|
25.4 months
Interval 19.8 to
There was an insufficient number of events therefore an upper limit could not be calculated
|
—
|
—
|
Adverse Events
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
Other adverse events
| Measure |
Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
n=6 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
|
Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
n=5 participants at risk
Three-month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + 1000 mg oral daily with 5mg oral prednisone daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: 200 mg IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. TLR9 agonist SD-101 will be injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Localized edema
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
80.0%
4/5 • Number of events 5 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
80.0%
4/5 • Number of events 6 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 8 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatobilliary disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications, Other
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Up to 3 years
|
60.0%
3/5 • Number of events 4 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
40.0%
2/5 • Number of events 4 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
3/5 • Number of events 8 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • Number of events 9 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
60.0%
3/5 • Number of events 4 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Up to 3 years
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Investigations
Weight Gain
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
40.0%
2/5 • Number of events 6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 5 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
4/5 • Number of events 4 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
80.0%
4/5 • Number of events 7 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Proctitis
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
60.0%
3/5 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Up to 3 years
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 3 • Up to 3 years
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
50.0%
3/6 • Number of events 5 • Up to 3 years
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 5 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
100.0%
5/5 • Number of events 5 • Up to 3 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 2 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
Chills
|
0.00%
0/5 • Up to 3 years
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/5 • Up to 3 years
|
40.0%
2/5 • Number of events 3 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Edema Limbs
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
General disorders
Flu-like symptoms
|
0.00%
0/5 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
Additional Information
Dr. David Oh, MD, PhD
University of California, San Francisco
Phone: (415) 476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place