Trial Outcomes & Findings for CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (NCT NCT04698187)
NCT ID: NCT04698187
Last Updated: 2025-06-11
Results Overview
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
TERMINATED
PHASE2
44 participants
Up to approximately 24 months (107 weeks)
2025-06-11
Participant Flow
Participant milestones
| Measure |
CMP-001 + Nivolumab
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
CMP-001 + Nivolumab
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Death
|
21
|
|
Overall Study
Sponsor Decision
|
15
|
|
Overall Study
In-transit Disease
|
1
|
Baseline Characteristics
CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Age, Continuous
|
60.7 Years
STANDARD_DEVIATION 14.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: Intent-to-Treat (ITT) Analysis Set (included all participants who received at least 1 \[partial or full\] dose of study treatment)
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
|
11.4 Percentage of participants
Interval 3.79 to 24.56
|
SECONDARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any TEAE
|
44 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any serious TEAE
|
12 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any TEAE leading to death
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 1 Mild
|
2 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 2 Moderate
|
18 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 3 Severe
|
21 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 4 Life-threatening
|
2 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 5 Death
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Number of participants analyzed for TTR included only participants who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
TTR, defined as the time from the first dose date of the study treatment to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST v1.1 by BICR.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=5 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Time to Response (TTR) by BICR
|
2.89 Months
Interval 2.69 to 5.32
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Number of participants analyzed for TTR included only participants who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
TTR, defined as the time from the first dose date of the study treatment to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST v1.1 by Investigator.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=7 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Time to Response (TTR) by Investigator
|
2.89 Months
Interval 2.53 to 4.86
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Number of participants analyzed for DOR included only participants who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST v1.1 by BICR.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=5 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Duration of Response (DOR) by BICR
|
NA Months
Interval 3.351 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Number of participants analyzed for DOR included only participants who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST v1.1 by Investigator.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=7 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Duration of Response (DOR) by Investigator
|
NA Months
Interval 3.351 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: Number of participants analyzed included only participants who had at least one non-injected target lesion.
Confirmed ORR, defined as the percentage of participants in the analysis set who had confirmed BOR of CR or PR based on RECIST v1.1 as assessed by Investigator.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=43 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Confirmed ORR in Non-injected Target Lesions by Investigator
|
16.3 Percentage of participants
Interval 6.81 to 30.7
|
SECONDARY outcome
Timeframe: Up to approximately 31 months (135 weeks)Population: ITT Analysis Set (included all participants who received at least 1 \[partial or full\] dose of study treatment)
PFS, defined as time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 by BICR or death, whichever occurred first.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Progression-free Survival (PFS) by BICR
|
2.83 Months
Interval 2.595 to 4.731
|
SECONDARY outcome
Timeframe: Up to approximately 31 months (135 weeks)Population: ITT Analysis Set (included all participants who received at least 1 \[partial or full\] dose of study treatment)
PFS, defined as time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 by Investigator or death, whichever occurred first.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Progression-free Survival (PFS) by Investigator
|
2.79 Months
Interval 2.628 to 4.172
|
SECONDARY outcome
Timeframe: Up to approximately 32 months (139 weeks)Population: ITT Analysis Set (included all participants who received at least 1 \[partial or full\] dose of study treatment)
OS, defined as the time from the first dose date of the study treatment to the date of death from any cause.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Overall Survival (OS) by Investigator
|
18.43 Months
Interval 0.76 to 31.93
|
SECONDARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: iORR is only defined for participants who continued study treatment beyond progressive disease (PD) per RECIST v1.1 as assessed by the Investigator according to immunotherapy RECIST (iRECIST). Here, 6 participants met the criteria for iORR assessment.
iORR, defined as the percentage of participants with an immune best overall response (iBOR) of confirmed immune complete response (iCR) or confirmed immune partial response (iPR) based on immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator assessment.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=6 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Immune Objective Response Rate (iORR) by Investigator
|
NA Percentage of Participants
Insufficient number of participants with immune response
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: iDOR is only defined for participants who had a confirmed iBOR of iCR or iPR. Here, 0 participants met the criteria.
iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by Investigator assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 9 months (approximately 39 weeks)Population: ITT Analysis Set (included all participants who received at least 1 \[partial or full\] dose of study treatment)
iPFS, defined as the time from the first dose date of the study treatment to date of immune confirmed progressive disease (iCPD) per iRECIST by Investigator assessment or death, whichever occurred first.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=44 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Immune Progression-free Survival (iPFS) by Investigator
|
8.542 Months
Interval 0.03 to 9.0
|
SECONDARY outcome
Timeframe: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)Population: Per protocol, the pharmacokinetic (PK) Analysis Set was defined as all participants who received CMP-001 and had evaluable serum samples at Baseline and after CMP-001 injection. Here, no participants had evaluable serum samples at any time therefore, Number of Participants Analyzed equals 0.
Assess the pharmacokinetic (PK) profile for maximum observed serum concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)Population: Per protocol, the pharmacokinetic (PK) Analysis Set was defined as all participants who received CMP-001 and had evaluable serum samples at Baseline and after CMP-001 injection. Here, no participants had evaluable serum samples at any time therefore, Number of Participants Analyzed equals 0.
Assess the PK profile for area under the serum concentration-time curve from time zero to the last quantifiable time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)Population: Per protocol, the pharmacokinetic (PK) Analysis Set was defined as all participants who received CMP-001 and had evaluable serum samples at Baseline and after CMP-001 injection. Here, no participants had evaluable serum samples at any time therefore, Number of Participants Analyzed equals 0.
Assess the PK profile for area under the serum concentration-time curve from time zero extrapolated to infinity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of drug (Week 1 Day 1) until 30 days after the last drug injection (until a reason for treatment discontinuation occurs)Population: Per protocol, the pharmacokinetic (PK) Analysis Set was defined as all participants who received CMP-001 and had evaluable serum samples at Baseline and after CMP-001 injection. Here, no participants had evaluable serum samples at any time therefore, Number of Participants Analyzed equals 0.
Assess the PK profile for terminal elimination half-life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 months (107 weeks)Population: The Immunogenicity Analysis Set is defined as all participants who received at least 1 dose of CMP-001 and have at least 1 non-missing ADA result after CMP-001 administration.
Development of anti-Qbeta antibodies in participants with refractory unresectable or metastatic melanoma.
Outcome measures
| Measure |
CMP-001 + Nivolumab
n=41 Participants
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Number of Participants With Immunogenicity as Measured by Anti-Qbeta Antibodies (ADA)
|
41 Participants
|
Adverse Events
CMP-001 + Nivolumab
Serious adverse events
| Measure |
CMP-001 + Nivolumab
n=44 participants at risk
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.5%
2/44 • Number of events 2 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Influenza like illness
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
COVID-19
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
Soft tissue infection
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Cardiac disorders
Stress cardiomyopathy
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Immune system disorders
Cytokine release syndrome
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Nervous system disorders
Spinal cord compression
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/44 • Number of events 1 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
Other adverse events
| Measure |
CMP-001 + Nivolumab
n=44 participants at risk
All participants received CMP-001 intratumorally (IT) and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|
|
General disorders
Fatigue
|
47.7%
21/44 • Number of events 40 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Chills
|
45.5%
20/44 • Number of events 51 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Pyrexia
|
45.5%
20/44 • Number of events 43 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Injection site erythema
|
20.5%
9/44 • Number of events 9 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Injection site pain
|
20.5%
9/44 • Number of events 10 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Oedema peripheral
|
15.9%
7/44 • Number of events 11 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Influenza like illness
|
11.4%
5/44 • Number of events 16 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Chest discomfort
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Injection site reaction
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Injection site swelling
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
General disorders
Localised oedema
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.7%
10/44 • Number of events 19 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.5%
9/44 • Number of events 17 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.5%
9/44 • Number of events 24 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
8/44 • Number of events 10 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
5/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Nausea
|
38.6%
17/44 • Number of events 25 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
16/44 • Number of events 23 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Constipation
|
15.9%
7/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
6/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • Number of events 6 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Vascular disorders
Hypotension
|
34.1%
15/44 • Number of events 31 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Vascular disorders
Hypertension
|
15.9%
7/44 • Number of events 21 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Vascular disorders
Flushing
|
6.8%
3/44 • Number of events 5 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.2%
8/44 • Number of events 14 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
7/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.9%
7/44 • Number of events 10 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.4%
5/44 • Number of events 9 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.4%
5/44 • Number of events 9 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.4%
5/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Lipase increased
|
15.9%
7/44 • Number of events 10 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
6/44 • Number of events 6 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Blood alkaline phosphatase increased
|
11.4%
5/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.1%
4/44 • Number of events 10 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Amylase increased
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Blood creatinine increased
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Lymphocyte count decreased
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Neutrophil count decreased
|
6.8%
3/44 • Number of events 13 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Weight decreased
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Investigations
Weight increased
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Nervous system disorders
Headache
|
27.3%
12/44 • Number of events 19 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Nervous system disorders
Dizziness
|
18.2%
8/44 • Number of events 9 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
29.5%
13/44 • Number of events 31 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.5%
9/44 • Number of events 11 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
7/44 • Number of events 9 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
4/44 • Number of events 5 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
6/44 • Number of events 6 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.6%
6/44 • Number of events 8 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
COVID-19
|
11.4%
5/44 • Number of events 6 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Infections and infestations
Skin infection
|
6.8%
3/44 • Number of events 4 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Cardiac disorders
Tachycardia
|
9.1%
4/44 • Number of events 7 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Cardiac disorders
Sinus tachycardia
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
4/44 • Number of events 5 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
6.8%
3/44 • Number of events 3 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
6.8%
3/44 • Number of events 8 • From signing of informed consent through end of study up to approximately 32 months (139 weeks).
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
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