Trial Outcomes & Findings for Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas (NCT NCT03255018)
NCT ID: NCT03255018
Last Updated: 2023-11-28
Results Overview
Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Overall Study
Death on study
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
Baseline characteristics by cohort
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=10 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
|
Age, Continuous
|
56.53 years
STANDARD_DEVIATION 25.26 • n=2 Participants
|
65.06 years
STANDARD_DEVIATION 7.25 • n=10 Participants
|
62.93 years
STANDARD_DEVIATION 13 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
10 participants
n=10 Participants
|
12 participants
n=12 Participants
|
|
Baseline Programmed Death-Ligand 1 (PD-L1) Status
Positive
|
0 Participants
n=1 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
1 Participants
n=2 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
1 Participants
n=3 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
|
Baseline Programmed Death-Ligand 1 (PD-L1) Status
Negative
|
1 Participants
n=1 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
1 Participants
n=2 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
2 Participants
n=3 Participants • No tissue available for analyses for one participant in Cohort 1 and 8 participants in Cohort 2.
|
|
Baseline Bone Marrow Involvement
Positive
|
0 Participants
n=2 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
1 Participants
n=5 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
1 Participants
n=7 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
|
Baseline Bone Marrow Involvement
Negative
|
2 Participants
n=2 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
4 Participants
n=5 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
6 Participants
n=7 Participants • No bone marrow biopsy performed for 5 participants in cohort 2.
|
|
Baseline Cerebral Spinal Fluid (CSF) Involvement
Positive
|
0 Participants
2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
4 Participants
n=8 Participants • 2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
4 Participants
n=8 Participants • 2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
|
Baseline Cerebral Spinal Fluid (CSF) Involvement
Negative
|
0 Participants
2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
4 Participants
n=8 Participants • 2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
4 Participants
n=8 Participants • 2 participants did not receive lumbar punctures in Cohort 1 and Cohort 2.
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Complete Response
|
50 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Unconfirmed Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Partial Response
|
0 percentage of participants
|
11 percentage of participants
|
|
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Progressive Disease
|
50 percentage of participants
|
89 percentage of participants
|
SECONDARY outcome
Timeframe: Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy, approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.Population: 9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Grade 1
|
5 adverse events
|
35 adverse events
|
|
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Grade 2
|
0 adverse events
|
20 adverse events
|
|
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Grade 3
|
0 adverse events
|
8 adverse events
|
|
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Grade 4
|
0 adverse events
|
2 adverse events
|
|
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Grade 5
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: every 3-6 months for 24 monthsPopulation: For this outcome only 1 out of the 2 participants in the GZL cohort had a PET scan at the time of best response. In the DLBCL cohort only 6 out of the 9 had a PET Scan at the time of best response.
The response rate is calculated by dividing the number of participants that had a complete response (CR) or partial response (PR) to therapy measured on positron emission tomography (PET) scan in accordance with the 5-point Lugano classification. Best overall response is the best response (complete or partial response) recorded from the start of the treatment until disease progression/recurrence. The 5-Point Scale Deauville criteria scores the most intense uptake in a site of initial disease: no uptake or no residual uptake, slight uptake, but above blood pool, uptake above mediastinal but below or =to uptake in liver, uptake slightly to moderately higher than liver, \& markedly increased uptake. 5Point Scale ranges:1 to 5, 1=best; 5=worst: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver; X. CR=scores 1-3 on \& PR is calculated by measured change from baseline (score 4 or 5).
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=1 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=6 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
Complete Response
|
100 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
Partial Response
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
Stable Disease
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
Progressive Disease
|
0 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: every 3-6 months for 24 monthsPopulation: 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
DOR is beginning at the date clinical response is first identified; measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is documented and will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Complete response is \<1 cm lymph nodes/lymph node masses, and normal bone marrow/physical exam (PE); unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease lymph node masses, normal PE and indeterminate in bone marrow; partial response is ≥50% decrease in lymph nodes/lymph node masses, decrease in liver/spleen and irrelevant in bone marrow; and progression is \>50% new or increased lymph node masses/lymph nodes, enlarging liver/spleen, and reappearance in bone marrow.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Duration of Response for Participants Who Respond to Pembrolizumab
|
18.25 Months
Interval 0.0 to 36.5
|
0.9 Months
Interval 0.0 to 0.9
|
SECONDARY outcome
Timeframe: up to 2 monthsPopulation: 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. PFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
NA Months
Median PFS not reached due to more than 50% of participants in the GZL cohort not experiencing a progression event.
|
1.4 Months
Interval 0.5 to 2.3
|
SECONDARY outcome
Timeframe: up to 2 monthsPopulation: 1 participant in the GZL cohort, and 1 participant enrolled in the DLBCL cohort 1 were not evaluable due to withdrawal of consent prior to treatment.
EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. EFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Event-free Survival (EFS)
|
NA Months
Median EFS not reached due to more than 50% of participants in the GZL cohort not experiencing a progression event.
|
1.4 Months
Interval 0.5 to 2.3
|
SECONDARY outcome
Timeframe: every 3-6 months, up to 2.5 yearsPopulation: 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
OS is the time from treatment start date until date of death from any cause, date last known alive or last follow up. OS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median OS was not reached due to more than 50% of participants still being alive.
|
28.8 Months
Interval 1.1 to
The upper confidence interval (CI) is not estimable. The upper CI is not estimable when there are insufficient (or no) events past the time reported to calculate the upper CI limit. It is mathematically not possible to determine the upper limit in those cases.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.Population: 9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the participant or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 Participants
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 Participants
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
|
2 Participants
|
9 Participants
|
Adverse Events
Cohort 1 Gray-Zone Lymphoma (GZL)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 participants at risk
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 participants at risk
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Eye disorders
Eye disorders - Other, vision decreased
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
Other adverse events
| Measure |
Cohort 1 Gray-Zone Lymphoma (GZL)
n=2 participants at risk
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
n=9 participants at risk
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL)
Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 3 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Dysarthria
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
33.3%
3/9 • Number of events 4 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Fever
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 5 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Flatulence
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
33.3%
3/9 • Number of events 3 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Thrush
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 3 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 4 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
33.3%
3/9 • Number of events 4 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 3 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
22.2%
2/9 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
2/2 • Number of events 2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Sore throat
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
0.00%
0/9 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
11.1%
1/9 • Number of events 1 • Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place