Trial Outcomes & Findings for Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma (NCT NCT03179917)
NCT ID: NCT03179917
Last Updated: 2026-09-02
Results Overview
Complete response rate following Pembrolizumab-ISRT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
2 years
Results posted on
2026-09-02
Participant Flow
Participant milestones
| Measure |
CMR Group
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
5
|
|
Overall Study
COMPLETED
|
7
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
CMR Group
n=7 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=136 Participants
|
46 years
n=136 Participants
|
37 years
n=272 Participants
|
36 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
12 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
10 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
3 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=136 Participants
|
9 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
18 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=136 Participants
|
9 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
18 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=136 Participants
|
10 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
22 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 2 yearsComplete response rate following Pembrolizumab-ISRT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
CMR Group
n=7 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Complete Response Rate Following Pembrolizumab-ISRT
Complete Response
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Complete Response Rate Following Pembrolizumab-ISRT
No Complete Response
|
0 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOverall response rate following single-agent Pembrolizumab
Outcome measures
| Measure |
CMR Group
n=7 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Overall Response Rate Following Single-agent Pembrolizumab
Overall Response Rate
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Overall Response Rate Following Single-agent Pembrolizumab
No Response
|
0 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsComplete response rate following single-agent Pembrolizumab
Outcome measures
| Measure |
CMR Group
n=7 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Complete Response Rate Following Single-agent Pembrolizumab
Complete Response
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Complete Response Rate Following Single-agent Pembrolizumab
No Complete Response
|
0 Participants
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOverall Progression Free Survival/PFS at 2 Years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
CMR Group
n=22 Participants
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Progression Free Survival/PFS
|
63.3 percentage of participants
Interval 39.8 to 79.7
|
—
|
—
|
Adverse Events
CMR Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PMR/SD Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
POD Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CMR Group
n=7 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
Other adverse events
| Measure |
CMR Group
n=7 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
PMR/SD Group
n=10 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
POD Group
n=5 participants at risk
Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Pembrolizumab: pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.
Involved Site Radiation Therapy: 30 Gy of ISRT
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
rash-erythema
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Eye disorders
blurred vision and light sensitivity
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
General disorders
Chills
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
General disorders
Edema limbs
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Investigations
elevated TSH
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
General disorders
Fatigue
|
14.3%
1/7 • 2 years
|
30.0%
3/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
General disorders
Fever
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Endocrine disorders
Hypothryoidism
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
20.0%
1/5 • 2 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/5 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/5 • 2 years
|
Additional Information
Dr. Alison Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place