Trial Outcomes & Findings for Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma (NCT NCT03063632)
NCT ID: NCT03063632
Last Updated: 2023-10-25
Results Overview
Participants in Treatment Group 1 will be assessed for response and progression using standard response criteria in patients with Mycosis Fungoides and Sezary syndrome. Per Global Response Score determined by evaluating skin, lymph nodes, internal organs (viscera), and blood specimens: Complete Response (CR), complete disappearance of all clinical evidence of disease; Partial Response (PR), regression of measurable disease. Participants in Treatment Group 2 will be assessed for response and progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR) disappearance of all lesions and no new lesion; Partial Response (PR), 30% or greater reduction in tumor size and no new lesions. The ORR is defined as CR combined with PR. Will be assessed using binomial proportion. Best response at any timepoint was used to determine ORR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-10-25
Participant Flow
Participant milestones
| Measure |
Group I (Pembrolizumab, Interferon Gamma-1b)
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, Interferon Gamma-1b)
Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
12
|
|
Overall Study
COMPLETED
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Group I (Pembrolizumab, Interferon Gamma-1b)
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, Interferon Gamma-1b)
Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Overall Study
Death
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Other: Disease progression; starting another treatment
|
1
|
1
|
Baseline Characteristics
Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma
Baseline characteristics by cohort
| Measure |
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, Interferon Gamma-1b)
n=12 Participants
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Both Treatment Group 1 and Treatment Group 2 study participants received at least one dose of IV pembrolizumab on study, and 27 participants received at least one dose of Interferon gamma on study. While not all participants reached the first disease assessment timepoint specified in the protocol, all had documented disease status at the time of treatment or study discontinuation. Therefore, no study participants were excluded from ORR analysis due to missing data.
Participants in Treatment Group 1 will be assessed for response and progression using standard response criteria in patients with Mycosis Fungoides and Sezary syndrome. Per Global Response Score determined by evaluating skin, lymph nodes, internal organs (viscera), and blood specimens: Complete Response (CR), complete disappearance of all clinical evidence of disease; Partial Response (PR), regression of measurable disease. Participants in Treatment Group 2 will be assessed for response and progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR) disappearance of all lesions and no new lesion; Partial Response (PR), 30% or greater reduction in tumor size and no new lesions. The ORR is defined as CR combined with PR. Will be assessed using binomial proportion. Best response at any timepoint was used to determine ORR.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
n=12 Participants
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years and 1 monthsPopulation: All treated subjects.
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
n=12 Participants
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Incidence of Adverse Events
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Time interval between the date of first treatment and the date of response (complete response [CR]/partial response [PR]), up to 2 yearsPopulation: Non-responders are excluded in the analysis.
Will use simple statistics.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=6 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Time to Response (TTR)
|
—
|
126 days
Interval 106.0 to 463.0
|
SECONDARY outcome
Timeframe: Time interval between the date of first response (CR/PR) and the date of progression, up to 2 years and 11 monthsPopulation: Non-responders are excluded in analysis; censored at last follow-up or start of new significant therapy
Will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=6 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Duration of Response (DOR)
|
—
|
505.0 days
Interval 106.0 to
Insufficient number of events to calculate upper CI.
|
SECONDARY outcome
Timeframe: Time from enrollment to disease progression or death, whichever occurs earlier, based upon investigator assessment, up to 3 yearsPopulation: All efficacy or safety evaluable patients. Censored at last follow-up or start of new significant therapy.
Will be assessed using the Kaplan-Meier method
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
n=6 Participants
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS)
|
196.5 days
Interval 32.0 to
Insufficient number of events to calculate upper limit of CI
|
394.0 days
Interval 120.0 to 615.0
|
SECONDARY outcome
Timeframe: Termination due to toxicity, initiation of next significant treatment, progressive disease, or death of any cause, up to 2 yearsPopulation: All efficacy or safety evaluable patients. Event is defined by early termination due to toxicity, start of new significant therapy, PD, or death of any cause.
Will be assessed using the Kaplan-Meier method.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
n=6 Participants
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Event-free Survival (EFS)
|
73.0 days
Interval 32.0 to
Insufficient number of events to calculate upper limit of CI
|
185.5 days
Interval 120.0 to 394.0
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date beyond 12 months that recurrent disease is objectively documented, up to 2 yearsPopulation: Evaluable duration of response beyond 12 months for evaluable population.
Will be assessed per global assessment of mycosis fungoides and Sezary syndrome (confirmed \& investigator assessed). Will use binomial distribution.
Outcome measures
| Measure |
Group II (Pembrolizumab, Interferon Gamma-1b)
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group I (Pembrolizumab, Interferon Gamma-1b)
n=2 Participants
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Rate of Overall Response Duration Beyond 12 Months (ORR12)
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsClinical response (as measured by the primary and secondary endpoints) to combination immunotherapy regimen as a function of biomarkers will be evaluated. All biomarker assays will be run on the clinical trial samples in a blinded manner. Time to event endpoints (DOR, PFS, EFS) will be evaluated using Kaplan-Meier curves generated by biomarker scoring group using the log-rank test. Exploratory outcomes will be summarized with descriptive statistics (primarily proportions and medians) for all biomarkers described above, and additionally, serum IL-10, regulatory T-cells, and activated CD8 T cells. Scatterplots and Kendall's tau estimates will be produced for estimating correlation of PD-1, PDL1, or PD-L2 expression measures and clinical outcome across compartments (skin, lymph node, blood). Comparison of tissue immunohistochemistry markers between pre-treatment and with clinical response or disease progression will be assessed using Wilcoxon signed-rank test.
Outcome measures
Outcome data not reported
Adverse Events
Group I (Pembrolizumab, Interferon Gamma-1b)
Serious events: 4 serious events
Other events: 15 other events
Deaths: 4 deaths
Group II (Pembrolizumab, Interferon Gamma-1b)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 participants at risk
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, Interferon Gamma-1b)
n=12 participants at risk
Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Infections and infestations
Soft tissue infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Bone infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Urinary tract Infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Disease progression
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
Other adverse events
| Measure |
Group I (Pembrolizumab, Interferon Gamma-1b)
n=16 participants at risk
Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, Interferon Gamma-1b)
n=12 participants at risk
Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Interferon Gamma-1b: Given SC
Laboratory Biomarker Analysis: Ancillary studies
Pembrolizumab: Given IV
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
33.3%
4/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Urinary tract Infection
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
66.7%
8/12 • Number of events 22 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Bladder infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Concentration impairment
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 11 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Chills
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
50.0%
6/12 • Number of events 7 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Cholesterol high
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 4 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Edema face
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Fatigue
|
31.2%
5/16 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
41.7%
5/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Eye infection
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Fever
|
12.5%
2/16 • Number of events 4 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
41.7%
5/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Flu like symptoms
|
12.5%
2/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
41.7%
5/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Injury, poisoning and procedural complications
Fracture
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 4 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 6 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 7 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 7 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16 • Number of events 4 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 6 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
INR increased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
50.0%
6/12 • Number of events 26 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Eye disorders
Keratitis
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
33.3%
4/12 • Number of events 4 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
4/16 • Number of events 6 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Infections and Infestations, Other
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Investigations - Other
|
12.5%
2/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
25.0%
3/12 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/16 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
31.2%
5/16 • Number of events 5 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Skin infection
|
12.5%
2/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
18.8%
3/16 • Number of events 3 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
Weight loss
|
6.2%
1/16 • Number of events 1 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
|
Investigations
White blood cell count decreased
|
6.2%
1/16 • Number of events 2 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
0.00%
0/12 • Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60