Trial Outcomes & Findings for HDCRT Plus Pembrolizumab in Advanced Malignancies (NCT NCT02987166)
NCT ID: NCT02987166
Last Updated: 2026-06-15
Results Overview
Adverse events related to HDCRT with immunotherapy, delivered concurrently (Arm A) or sequentially (Arms B and C)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
up to 24 months for adverse events; up to 27 months for serious adverse events
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
Arm A: HDCRT Administered With First Dose of Pembrolizumab
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HDCRT Plus Pembrolizumab in Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Arm A: HDCRT Administered With First Dose of Pembrolizumab
n=7 Participants
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab
n=6 Participants
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab
n=8 Participants
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Type
Breast Cancer
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Cancer Type
Colon Cancer
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Type
GE Junctional Cancer
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Head and Neck Cancer
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Type
Leiomyosarcoma
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Melanoma
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Pancreatic Cancer
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Testicular Cancer
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 months for adverse events; up to 27 months for serious adverse eventsPopulation: The units analyzed are the number of adverse events experienced per arm.
Adverse events related to HDCRT with immunotherapy, delivered concurrently (Arm A) or sequentially (Arms B and C)
Outcome measures
| Measure |
ARM A Grade 1
n=13 Number of Adverse Events
Grade 1 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 2
n=7 Number of Adverse Events
Grade 2 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 3
n=1 Number of Adverse Events
Grade 3 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 4
Grade 4 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 5
Grade 5 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 1
n=14 Number of Adverse Events
Grade 1 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 2
n=2 Number of Adverse Events
Grade 2 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 3
n=5 Number of Adverse Events
Grade 3 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 4
Grade 4 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 5
Grade 5 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 1
n=14 Number of Adverse Events
Grade 1 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 2
n=8 Number of Adverse Events
Grade 2 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 3
n=1 Number of Adverse Events
Grade 3 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 4
Grade 4 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 5
Grade 5 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety: Adverse Event Profile
Anemia
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Other Blood Lymphatic
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Hyperthyroidism
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Hypothyroidism
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Nausea
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Vomiting
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Fatigue
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Fever
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Flu-like symptoms
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Radiation Dermatitis
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Fall
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Alanine Aminotransferase Increase
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Alkaline Phosphatase Increase
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Aspartate Aminotransferase Increase
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Blood Bilirubin Increase
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Lymphocyte Count Decrease
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
3 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Platelet Count Decrease
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
White Blood Cell Count Decrease
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Anorexia
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Hyperkalemia
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Hyperuricemia
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Arthralgia
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Myalgia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Dizziness
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Cough
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Non-Cardiac Chest Pain/ Chest Wall Pain
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Pruritus
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
|
Safety: Adverse Event Profile
Rash Maculo-papular
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
—
|
—
|
PRIMARY outcome
Timeframe: At Baseline, Day 22 of treatment, and Day 43 or treatmentPopulation: 14 out of the 21 subjects completed all 3 protocol required tumor biopsy and were evaluable for immunological analysis.
Log-normalized enumeration of CD8+ T cells and FoxP3+ cells in untreated and treated tumor tissue by immunohistochemical analysis to estimate group differences and changes over time in immune assay parameters in tumor.
Outcome measures
| Measure |
ARM A Grade 1
n=4 Participants
Grade 1 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 2
n=5 Participants
Grade 2 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 3
n=5 Participants
Grade 3 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 4
Grade 4 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 5
Grade 5 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 1
Grade 1 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 2
Grade 2 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 3
Grade 3 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 4
Grade 4 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 5
Grade 5 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 1
Grade 1 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 2
Grade 2 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 3
Grade 3 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 4
Grade 4 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 5
Grade 5 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Enumeration of T Cells in Tumor Tissue
CD8+ Baseline
|
1.69 log(cells/ mm^2 of biopsy)
Standard Deviation 0.49
|
1.84 log(cells/ mm^2 of biopsy)
Standard Deviation 0.5
|
1.61 log(cells/ mm^2 of biopsy)
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of T Cells in Tumor Tissue
FoxP3 Baseline
|
0.89 log(cells/ mm^2 of biopsy)
Standard Deviation 0.59
|
0.88 log(cells/ mm^2 of biopsy)
Standard Deviation 0.55
|
1.13 log(cells/ mm^2 of biopsy)
Standard Deviation 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of T Cells in Tumor Tissue
CD8+ Day 22
|
1.55 log(cells/ mm^2 of biopsy)
Standard Deviation 0.8
|
2.11 log(cells/ mm^2 of biopsy)
Standard Deviation 0.42
|
1.93 log(cells/ mm^2 of biopsy)
Standard Deviation 0.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of T Cells in Tumor Tissue
FoxP3 Day 22
|
1.59 log(cells/ mm^2 of biopsy)
Standard Deviation 0.09
|
1.78 log(cells/ mm^2 of biopsy)
Standard Deviation 0.7
|
1.4 log(cells/ mm^2 of biopsy)
Standard Deviation 0.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of T Cells in Tumor Tissue
CD8+ Day 43
|
1.92 log(cells/ mm^2 of biopsy)
Standard Deviation 0.58
|
1.89 log(cells/ mm^2 of biopsy)
Standard Deviation 0.69
|
1.71 log(cells/ mm^2 of biopsy)
Standard Deviation 0.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of T Cells in Tumor Tissue
FoxP3 Day 43
|
1.53 log(cells/ mm^2 of biopsy)
Standard Deviation 0.25
|
1.26 log(cells/ mm^2 of biopsy)
Standard Deviation 0.67
|
1.3 log(cells/ mm^2 of biopsy)
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Baseline and at Days 22 , 43, 64, and 85 of treatmentPopulation: Several participants discontinued the trial at various times, reducing the number of samples collected at later time points.
Enumeration of CD8+ and CD4+ T cells in untreated and treated blood samples to estimate group differences and changes over time in immune assay parameters in PBMC
Outcome measures
| Measure |
ARM A Grade 1
n=7 Participants
Grade 1 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 2
n=6 Participants
Grade 2 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 3
n=8 Participants
Grade 3 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 4
Grade 4 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM A Grade 5
Grade 5 Adverse events related to ARM A study intervention.
Study Intervention:
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 1
Grade 1 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 2
Grade 2 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 3
Grade 3 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 4
Grade 4 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM B Grade 5
Grade 5 Adverse events related to ARM B study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 1
Grade 1 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 2
Grade 2 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 3
Grade 3 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 4
Grade 4 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
ARM C Grade 5
Grade 5 Adverse events related to ARM C study intervention.
Study Intervention:
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Enumeration of Circulating Immune Cells
CD4+ Day 43
|
2.180 T cells/uL of blood
Standard Deviation 0.899
|
1.656 T cells/uL of blood
Standard Deviation 0.981
|
1.872 T cells/uL of blood
Standard Deviation 0.660
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD8+ Day 64
|
0.438 T cells/uL of blood
Standard Deviation 0.278
|
1.131 T cells/uL of blood
Standard Deviation 0.634
|
0.694 T cells/uL of blood
Standard Deviation 0.612
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD4+ Day 64
|
2.749 T cells/uL of blood
Standard Deviation 0.267
|
1.688 T cells/uL of blood
Standard Deviation 0.665
|
2.145 T cells/uL of blood
Standard Deviation 0.491
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD8+ Day 85
|
0.736 T cells/uL of blood
Standard Deviation 0
|
1.287 T cells/uL of blood
Standard Deviation 0.927
|
0.777 T cells/uL of blood
Standard Deviation 0.449
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD4+ Day 85
|
3.484 T cells/uL of blood
Standard Deviation 0
|
2.223 T cells/uL of blood
Standard Deviation 1.536
|
2.128 T cells/uL of blood
Standard Deviation 0.843
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD8+ Baseline
|
0.770 T cells/uL of blood
Standard Deviation 0.605
|
1.159 T cells/uL of blood
Standard Deviation 0.754
|
0.717 T cells/uL of blood
Standard Deviation 0.486
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD4+ Baseline
|
2.283 T cells/uL of blood
Standard Deviation 1.498
|
1.939 T cells/uL of blood
Standard Deviation 1.461
|
2.589 T cells/uL of blood
Standard Deviation 1.071
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD8+ Day 22
|
0.636 T cells/uL of blood
Standard Deviation 0.337
|
1.091 T cells/uL of blood
Standard Deviation 0.737
|
0.575 T cells/uL of blood
Standard Deviation 0.359
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD4+ Day 22
|
2.276 T cells/uL of blood
Standard Deviation 1.629
|
1.536 T cells/uL of blood
Standard Deviation 0.792
|
2.115 T cells/uL of blood
Standard Deviation 1.241
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Enumeration of Circulating Immune Cells
CD8+ Day 43
|
1.255 T cells/uL of blood
Standard Deviation 0.561
|
1.055 T cells/uL of blood
Standard Deviation 0.920
|
0.506 T cells/uL of blood
Standard Deviation 0.343
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A: HDCRT Administered With First Dose of Pembrolizumab
Serious events: 2 serious events
Other events: 7 other events
Deaths: 3 deaths
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A: HDCRT Administered With First Dose of Pembrolizumab
n=7 participants at risk
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab
n=6 participants at risk
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab
n=8 participants at risk
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
Other adverse events
| Measure |
Arm A: HDCRT Administered With First Dose of Pembrolizumab
n=7 participants at risk
Pembrolizumab (200 mg) plus HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) are both administered beginning on day 1.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm B: HDCRT Administered Between Doses 1& 2 of Pembrolizumab
n=6 participants at risk
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 22.
Pembrolizumab (200 mg) will be administered on days 1, 43, 64, 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the 4 doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 22.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
Arm C: HDCRT Administered Prior to First Dose of Pembrolizumab
n=8 participants at risk
Pembrolizumab (200 mg) begins on day 1. HDCRT (24 Gy in 3 fractions of 8 Gy each for bone and/or soft tissue lesions; 30 Gy in 5 fractions of 6 Gy each for the prostate gland) begins on day 1.
Pembrolizumab will be administered on days 22, 43, 64, and 85. Subjects who have measurable disease outside of the radiation field and who have derived benefit from the four doses of pembrolizumab may continue to receive pembrolizumab every 3 weeks for up to 2 years.
HDCRT will be administered to the primary tumor and/or sites of metastatic disease (1 or more sites permitted) over a period of 3-5 days. The length of time for administration of the HDCRT will depend on the site of disease that is to be radiated. HDCRT will begin on day 1.
High-Dose Conformal Radiation Therapy: 24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
30 Gy in 5 fractions of 6 Gy each for prostate gland
Pembrolizumab: 200 mg
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
83.3%
5/6 • Number of events 8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
3/6 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Number of events 6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
66.7%
4/6 • Number of events 5 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
4/8 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Blood bilirubin increased
|
28.6%
2/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Renal and urinary disorders
Cystitis noninfective
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Eye disorders
blepharitis
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
3/6 • Number of events 6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
4/8 • Number of events 5 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Chest Wall pain
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
37.5%
3/8 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Activated partial thromboplastin time prolonged
|
28.6%
2/7 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
33.3%
2/6 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Alkaline phosphatase increased
|
71.4%
5/7 • Number of events 5 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
3/6 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
42.9%
3/7 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
33.3%
2/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
4/8 • Number of events 5 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
3/6 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
4/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
INR increased
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Lymphocyte count decreased
|
57.1%
4/7 • Number of events 7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
100.0%
6/6 • Number of events 10 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
37.5%
3/8 • Number of events 7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.1%
4/7 • Number of events 4 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
33.3%
2/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
General disorders
Pain
|
57.1%
4/7 • Number of events 7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
33.3%
2/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
25.0%
2/8 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
50.0%
3/6 • Number of events 3 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
33.3%
2/6 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Vascular disorders
Pulmonary embolism
|
14.3%
1/7 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
12.5%
1/8 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
Weight loss
|
28.6%
2/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 2 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/6 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
16.7%
1/6 • Number of events 1 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
0.00%
0/8 • up to 24 months for adverse events; up to 27 months for serious adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place