Trial Outcomes & Findings for Study of the PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Patients With Relapsed or Refractory Advanced Stage Follicular Lymphoma (NCT NCT03465891)
NCT ID: NCT03465891
Last Updated: 2021-01-12
Results Overview
objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
3 years
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Atezolizumab
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
|
Atezolizumab Plus Low-dose, Local Radiotherapy
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Atezolizumab
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
|
Atezolizumab Plus Low-dose, Local Radiotherapy
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Disease progression
|
1
|
0
|
Baseline Characteristics
Study of the PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Patients With Relapsed or Refractory Advanced Stage Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=1 Participants
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
|
Atezolizumab Plus Low-dose, Local Radiotherapy
n=1 Participants
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
atezolizumab: 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
Low- Dose, Local Radiotherapy: 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
39 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Data were not collected
objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atezolizumab Plus Low-dose, Local Radiotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place