Trial Outcomes & Findings for Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas (NCT NCT02332980)
NCT ID: NCT02332980
Last Updated: 2024-01-03
Results Overview
Confirmed response is defined to be a partial response, nodular partial response, clinical complete response, confirmed response with incomplete blood count recovery or confirmed response (Arm A and B), or complete metabolic response, partial metabolic response, partial response, or confirmed response (Arm C). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
1 year
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Arm A (CLL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
|---|---|---|---|
|
Initial Study Phase
STARTED
|
25
|
23
|
17
|
|
Initial Study Phase
COMPLETED
|
25
|
23
|
17
|
|
Initial Study Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Continuation Phase
STARTED
|
5
|
0
|
13
|
|
Continuation Phase
COMPLETED
|
5
|
0
|
13
|
|
Continuation Phase
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas
Baseline characteristics by cohort
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
67 years
n=7 Participants
|
68 years
n=5 Participants
|
69 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearConfirmed response is defined to be a partial response, nodular partial response, clinical complete response, confirmed response with incomplete blood count recovery or confirmed response (Arm A and B), or complete metabolic response, partial metabolic response, partial response, or confirmed response (Arm C). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Proportion of Patients Who Achieve a Confirmed Response
|
0.0800 proportion of responders
Interval 0.0098 to 0.2603
|
0 proportion of responders
Interval 0.0 to 0.1482
|
0 proportion of responders
Interval 0.0 to 0.1951
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined 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 |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Progression-free Survival of Patients Treated in Single Agent Phase
|
2.8 Months
Interval 1.4 to 4.6
|
4.2 Months
Interval 2.6 to 6.4
|
2.2 Months
Interval 0.7 to 2.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of progression-free survival will be estimated using the method of Kaplan-Meier. 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 |
Arm A (CLL)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Progression-free Survival of Patients Treated With Combination Therapy
|
7.6 Months
Interval 1.9 to
Not enough events occurred to calculate upper limit
|
5.4 Months
Interval 0.7 to 15.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Treatment-free Survival of Patients Treated With Single-agent Pembrolizumab
|
2.7 Months
Interval 2.1 to 3.2
|
4.6 Months
Interval 3.1 to 8.1
|
2.9 Months
Interval 0.8 to 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (CLL)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Treatment-free Survival of Patients Treated With Combination Therapy
|
7.7 Months
Interval 0.7 to
Not enough events occurred to calculate upper limit
|
3.2 Months
Interval 0.5 to 5.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of time to next treatment will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Time to Next Treatment for Patients Treated With Single-agent Pembrolizumab
|
3.0 Months
Interval 2.1 to 3.9
|
5.3 Months
Interval 3.4 to 10.1
|
3.0 Months
Interval 1.1 to 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of time to next treatment will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (CLL)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Time to Next Treatment for Patients on Combination Therapy
|
7.7 Months
Interval 0.7 to
Not enough events occurred to calculate upper limit
|
3.2 Months
Interval 0.5 to 5.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearWill be defined as complete response or incomplete blood count recovery. Estimated by the number of patients who achieve an incomplete blood count recovery or complete response divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true complete response rate will be calculated in each arm.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Complete Response Rate
|
0.0400 proportion of participants
Interval 0.001 to 0.2035
|
0 proportion of participants
Interval 0.0 to 0.1482
|
0 proportion of participants
Interval 0.0 to 0.1951
|
0.4000 proportion of participants
Interval 0.0527 to 0.8534
|
0 proportion of participants
Interval 0.0 to 0.2471
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Only patients that achieved a response were used in this analysis
The distribution of duration of response will be estimated using the method of Kaplan-Meier. Duration of response (DR) is defined for all evaluable patients who have achieved a PR, nPR, CCR, CRi, or CR (Arms A and B) or PMR, CMR, PR or CR (Arm C) as the date at which the patient's objective status is first noted to be a PR, nPR, CCR, CRi, or CR (Arms A and B) or PMR, CMR, PR or CR (Arm C) to the earliest date relapse is documented.
Outcome measures
| Measure |
Arm A (CLL)
n=2 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Duration of Response
|
6.9 Months
Interval 2.6 to
Not enough events occurred for upper limit calculation
|
—
|
—
|
5.9 Months
Interval 2.6 to
Not enough events occurred for upper limit calculation
|
NA Months
Interval 10.7 to
Not enough events occurred for median or upper limit calculation
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Overall Survival
|
10.6 Months
Interval 5.4 to 34.4
|
48.6 Months
Interval 13.0 to
Not enough events to estimate upper confidence limit
|
11.5 Months
Interval 4.1 to 17.6
|
11.7 Months
Interval 1.9 to
Not enough events to estimate upper confidence limit
|
13.3 Months
Interval 5.8 to
Not enough events to estimate upper confidence limit
|
SECONDARY outcome
Timeframe: 1 yearConfirmed response rate will be estimated by the number of patients with an objective status of complete response, incomplete blood count recovery, nodular partial response, clinical complete response or partial response while on the combination therapy divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate to the combination will be calculated. In addition, the responders on this study will be further examined in an exploratory manner to determine if there are any patterns in prognostic factors or disease characteristics, including whether the patient had a Richter's transformation or ibrutinib-resistant disease, for both single agent pembrolizumab and combination therapy responders.
Outcome measures
| Measure |
Arm A (CLL)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Confirmed All Response Rate of Patients Treated With Combination Therapy
|
0.6000 proportion of participants
Interval 0.1466 to 0.9473
|
0.1538 proportion of participants
Interval 0.0192 to 0.4545
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearWill be measured per National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be evaluated for single-agent pembrolizumab in each arm and also for the combination of pembrolizumab and the signal inhibitor in Arm A and Arm C. This outcome is reported in the adverse events section of this report.
Outcome measures
| Measure |
Arm A (CLL)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 Participants
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
25 Participants
|
23 Participants
|
17 Participants
|
5 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearMeasured at baseline and during treatment. Summarized descriptively by median, minimum, maximum and interquartile range. Overall response and complete response will be correlated with each measure using Wilcoxon rank sum test. The relationship between each measure and time to event measures will be evaluated using Cox proportional hazard models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearMeasured at baseline and during treatment. Summarized descriptively by median, minimum, maximum and interquartile range. Overall response and complete response will be correlated with each measure using Wilcoxon rank sum test. The relationship between each measure and time to event measures will be evaluated using Cox proportional hazard models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearMeasured at baseline and during treatment. Summarized descriptively by median, minimum, maximum and interquartile range. Overall response and complete response will be correlated with each measure using Wilcoxon rank sum test. The relationship between each measure and time to event measures will be evaluated using Cox proportional hazard models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 1 yearSummarized descriptively by median, minimum, maximum, and interquartile range (continuous factors) or frequency distribution (categorical factors) at each time point. Patterns over time summarized by absolute difference or relative change. Changes across time will be assessed using paired analyses, including Wilcoxon signed rank tests for continuous measures and McNemar's tests for categorical measures. Overall response and complete response will be correlated with continuous factors using Wilcoxon rank sum tests. Jitplots will be used to visually examine differences between groups for continuous factors. Overall response and complete response will be correlated with categorical factors using Fisher's exact tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 1 yearSummarized descriptively by median, minimum, maximum, and interquartile range (continuous factors) or frequency distribution (categorical factors) at each time point. Patterns over time summarized by absolute difference or relative change. Changes across time will be assessed using paired analyses, including Wilcoxon signed rank tests for continuous measures and McNemar's tests for categorical measures. Overall response and complete response will be correlated with continuous factors using Wilcoxon rank sum tests. Jitplots will be used to visually examine differences between groups for continuous factors. Overall response and complete response will be correlated with categorical factors using Fisher's exact tests.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (CLL)
Serious events: 15 serious events
Other events: 25 other events
Deaths: 18 deaths
Arm B (NHL)
Serious events: 9 serious events
Other events: 22 other events
Deaths: 14 deaths
Arm C (CLL With Richters)
Serious events: 8 serious events
Other events: 14 other events
Deaths: 13 deaths
Arm A (Continuation Phase)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Arm C (Continuation Phase)
Serious events: 6 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm A (CLL)
n=25 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 participants at risk
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 participants at risk
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Number of events 3 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
11.8%
2/17 • Number of events 2 • 5 years
|
40.0%
2/5 • Number of events 2 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 5 years
|
8.7%
2/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • 5 years
|
8.7%
2/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Lung infection
|
8.0%
2/25 • Number of events 2 • 5 years
|
8.7%
2/23 • Number of events 3 • 5 years
|
11.8%
2/17 • Number of events 2 • 5 years
|
40.0%
2/5 • Number of events 2 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
20.0%
1/5 • Number of events 2 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
8.0%
2/25 • Number of events 2 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Blood bilirubin increased
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Investigations
Creatinine increased
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Neutrophil count decreased
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Platelet count decreased
|
8.0%
2/25 • Number of events 3 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
40.0%
2/5 • Number of events 2 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Investigations
White blood cell decreased
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/25 • 5 years
|
8.7%
2/23 • Number of events 2 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
11.8%
2/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
11.8%
2/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Stroke
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
2/25 • Number of events 2 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
11.8%
2/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • Number of events 2 • 5 years
|
8.7%
2/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25 • Number of events 1 • 5 years
|
13.0%
3/23 • Number of events 3 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/25 • 5 years
|
8.7%
2/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
Other adverse events
| Measure |
Arm A (CLL)
n=25 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm B (NHL)
n=23 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (CLL With Richters)
n=17 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
|
Arm A (Continuation Phase)
n=5 participants at risk
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
Arm C (Continuation Phase)
n=13 participants at risk
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
92.0%
23/25 • Number of events 69 • 5 years
|
73.9%
17/23 • Number of events 87 • 5 years
|
82.4%
14/17 • Number of events 41 • 5 years
|
80.0%
4/5 • Number of events 18 • 5 years
|
100.0%
13/13 • Number of events 52 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 4 • 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
32.0%
8/25 • Number of events 15 • 5 years
|
39.1%
9/23 • Number of events 21 • 5 years
|
29.4%
5/17 • Number of events 9 • 5 years
|
80.0%
4/5 • Number of events 6 • 5 years
|
46.2%
6/13 • Number of events 22 • 5 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
10/25 • Number of events 15 • 5 years
|
39.1%
9/23 • Number of events 16 • 5 years
|
41.2%
7/17 • Number of events 12 • 5 years
|
60.0%
3/5 • Number of events 5 • 5 years
|
15.4%
2/13 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25 • Number of events 7 • 5 years
|
21.7%
5/23 • Number of events 6 • 5 years
|
29.4%
5/17 • Number of events 5 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
7.7%
1/13 • Number of events 3 • 5 years
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 2 • 5 years
|
|
General disorders
Fatigue
|
24.0%
6/25 • Number of events 7 • 5 years
|
17.4%
4/23 • Number of events 5 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Immune system disorders
Cytokine release syndrome
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
23.1%
3/13 • Number of events 3 • 5 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
20.0%
1/5 • Number of events 4 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
15.4%
2/13 • Number of events 2 • 5 years
|
|
Investigations
Creatinine increased
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 4 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
12.0%
3/25 • Number of events 4 • 5 years
|
26.1%
6/23 • Number of events 22 • 5 years
|
29.4%
5/17 • Number of events 6 • 5 years
|
0.00%
0/5 • 5 years
|
23.1%
3/13 • Number of events 3 • 5 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 2 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
30.8%
4/13 • Number of events 34 • 5 years
|
|
Investigations
Neutrophil count decreased
|
44.0%
11/25 • Number of events 20 • 5 years
|
30.4%
7/23 • Number of events 18 • 5 years
|
41.2%
7/17 • Number of events 11 • 5 years
|
80.0%
4/5 • Number of events 10 • 5 years
|
23.1%
3/13 • Number of events 7 • 5 years
|
|
Investigations
Platelet count decreased
|
76.0%
19/25 • Number of events 65 • 5 years
|
43.5%
10/23 • Number of events 46 • 5 years
|
70.6%
12/17 • Number of events 32 • 5 years
|
100.0%
5/5 • Number of events 39 • 5 years
|
76.9%
10/13 • Number of events 50 • 5 years
|
|
Investigations
White blood cell decreased
|
20.0%
5/25 • Number of events 8 • 5 years
|
43.5%
10/23 • Number of events 27 • 5 years
|
29.4%
5/17 • Number of events 7 • 5 years
|
60.0%
3/5 • Number of events 3 • 5 years
|
7.7%
1/13 • Number of events 5 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.0%
3/25 • Number of events 3 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
68.0%
17/25 • Number of events 33 • 5 years
|
60.9%
14/23 • Number of events 28 • 5 years
|
52.9%
9/17 • Number of events 15 • 5 years
|
60.0%
3/5 • Number of events 8 • 5 years
|
53.8%
7/13 • Number of events 20 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
56.0%
14/25 • Number of events 23 • 5 years
|
34.8%
8/23 • Number of events 16 • 5 years
|
29.4%
5/17 • Number of events 7 • 5 years
|
60.0%
3/5 • Number of events 3 • 5 years
|
23.1%
3/13 • Number of events 6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
2/25 • Number of events 2 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/25 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.0%
2/25 • Number of events 3 • 5 years
|
0.00%
0/23 • 5 years
|
5.9%
1/17 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/25 • 5 years
|
4.3%
1/23 • Number of events 1 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.0%
4/25 • Number of events 5 • 5 years
|
4.3%
1/23 • Number of events 3 • 5 years
|
11.8%
2/17 • Number of events 4 • 5 years
|
80.0%
4/5 • Number of events 7 • 5 years
|
23.1%
3/13 • Number of events 16 • 5 years
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 5 years
|
0.00%
0/23 • 5 years
|
0.00%
0/17 • 5 years
|
0.00%
0/5 • 5 years
|
0.00%
0/13 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place