Trial Outcomes & Findings for A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer (NCT NCT03430063)
NCT ID: NCT03430063
Last Updated: 2022-11-03
Results Overview
ORR was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm \[\<1 cm\]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From date of randomization up to 41 months
Results posted on
2022-11-03
Participant Flow
Due to early enrollment cessation, only 28 participants were randomized and 27 participants received study treatment in this study. One participant was randomized but not treated.
Of the 27 participants treated, four participants completed the study. The most common reason for study discontinuation was death (8 participants) followed by withdrawal of consent (6 participants), and progressive disease (4 participants).
Participant milestones
| Measure |
Cemiplimab 350 mg Q3W
Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
9
|
|
Overall Study
Treated
|
8
|
11
|
8
|
|
Overall Study
COMPLETED
|
0
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
8
|
Reasons for withdrawal
| Measure |
Cemiplimab 350 mg Q3W
Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Death
|
3
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
3
|
1
|
2
|
|
Overall Study
Progressive disease
|
1
|
2
|
1
|
|
Overall Study
Other un-specified
|
1
|
1
|
0
|
|
Overall Study
Randomized, but never treated
|
0
|
0
|
1
|
Baseline Characteristics
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Baseline characteristics by cohort
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 9.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Number of Participants with PD-L1 Tumor Expression Levels of ≥50% of Tumor Cells
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of randomization up to 41 monthsPopulation: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
ORR was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm \[\<1 cm\]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells
|
0 Percentage of participants
Interval 0.0 to 36.9
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
0 Percentage of participants
Interval 0.0 to 36.9
|
SECONDARY outcome
Timeframe: From date of randomization up to 41 monthsPopulation: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
Overall Response Rate was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm \[\<1 cm\]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Overall Response Rate
Complete Response
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Overall Response Rate
Partial Response
|
0 Percentage of participants
|
45.5 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Time from randomization to the date of death (up to 41 months)Population: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
OS was defined as the time from randomization to the date of death due to any cause. A participant who lost to follow-up was censored at the last date that the participant was known to be alive. OS was measured using Kaplan-Meier method.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
|
5.1 Months
Interval 1.7 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
NA Months
Interval 2.2 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
8.4 Months
Interval 1.4 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
SECONDARY outcome
Timeframe: Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)Population: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the IRC (based on RECIST 1.1 assessments) or death due to any cause, whichever occurred earlier. PFS was measured using Kaplan-Meier method.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
|
2.0 Months
Interval 0.7 to 8.3
|
20.8 Months
Interval 1.2 to
Upper limit of 95% CI was not estimable due to low number of events.
|
1.8 Months
Interval 1.1 to 2.2
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Number of participants with TEAEs, Serious TEAEs and TEAEs leading to death were reported.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Participants with any TEAE resulting in death
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Participants with any TEAE
|
7 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Participants with any serious TEAE
|
1 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).
The laboratory measurements included hematology, chemistry, electrolytes and liver function. NCI-CTCAE was graded according to the following scale: Grade 1 (Mild): Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 (Moderate): Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3 (Severe): Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated; Grade 5 (Death): Death related to AE.
Outcome measures
| Measure |
Cemiplimab 350 mg Q3W
n=8 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 Participants
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 Participants
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
Hematology
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
Electrolytes
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
Liver Function
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
Chemistry
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cemiplimab 350 mg Q3W
Serious events: 1 serious events
Other events: 7 other events
Deaths: 3 deaths
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
Serious events: 7 serious events
Other events: 11 other events
Deaths: 3 deaths
Cemiplimab 1050 mg Q3W
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cemiplimab 350 mg Q3W
n=8 participants at risk
Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 participants at risk
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 participants at risk
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 4 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Brain stem embolism
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Vascular disorders
Cyanosis
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
Other adverse events
| Measure |
Cemiplimab 350 mg Q3W
n=8 participants at risk
Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W
n=11 participants at risk
Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks \[Q6W\]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
Cemiplimab 1050 mg Q3W
n=8 participants at risk
Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
|
|---|---|---|---|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Investigations
Lipase increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 3 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 5 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 3 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Oral lichenoid reaction
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 3 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 2 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 4 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 5 • From first dose up to 41 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 4 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 3 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 2 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 3 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Eye disorders
Cataract
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/8 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 5 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Asthenia
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 5 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 2 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
General disorders
Pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
General disorders
Infusion site extravasation
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Oedema
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From first dose up to 41 months
|
18.2%
2/11 • Number of events 2 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
Investigations
Blood urea increased
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Transaminases increased
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Investigations
Weight decreased
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
4/8 • Number of events 4 • From first dose up to 41 months
|
27.3%
3/11 • Number of events 6 • From first dose up to 41 months
|
37.5%
3/8 • Number of events 4 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
25.0%
2/8 • Number of events 2 • From first dose up to 41 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/8 • From first dose up to 41 months
|
9.1%
1/11 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
|
Vascular disorders
Lymphoedema
|
12.5%
1/8 • Number of events 1 • From first dose up to 41 months
|
0.00%
0/11 • From first dose up to 41 months
|
0.00%
0/8 • From first dose up to 41 months
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER