Trial Outcomes & Findings for Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy (NCT NCT04646005)
NCT ID: NCT04646005
Last Updated: 2025-09-08
Results Overview
Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From enrollment to last dose (~up to 23 months)
Results posted on
2025-09-08
Participant Flow
229 participants were screened, and of these, 113 were enrolled and 116 were screen failures.
Participant milestones
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
113
|
Reasons for withdrawal
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Progressive Disease
|
71
|
|
Overall Study
Death
|
20
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Sponsor Request
|
9
|
Baseline Characteristics
Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
Baseline characteristics by cohort
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Objective Response Rate (ORR)
|
17.7 Percentage of Participants
Interval 10.7 to 24.7
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
877 Events
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
|
106 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)
|
10 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Participants With Any Serious TEAE
|
31 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Participants With at Least One Lab Abnormality
Coagulation Overall
|
9 Participants
|
|
Number of Participants With at Least One Lab Abnormality
Hematology Overall
|
88 Participants
|
|
Number of Participants With at Least One Lab Abnormality
Electrolytes Overall
|
56 Participants
|
|
Number of Participants With at Least One Lab Abnormality
Liver function Overall
|
66 Participants
|
|
Number of Participants With at Least One Lab Abnormality
Chemistry Overall
|
33 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Coagulation Overall
|
0 Participants
|
|
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Hematology Overall
|
27 Participants
|
|
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Electrolytes Overall
|
3 Participants
|
|
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Liver function Overall
|
3 Participants
|
|
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Chemistry Overall
|
3 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Duration of Response (DOR)
|
7.3 months
Interval 3.5 to 19.9
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Progression Free Survival (PFS)
|
3.0 Months
Interval 1.7 to 4.0
|
SECONDARY outcome
Timeframe: From enrollment to last dose (~up to 23 months)Population: The full analysis set (FAS) included all enrolled participants who received any study drug.
Outcome measures
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 Participants
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Overall Survival (OS)
|
14.3 Months
Interval 11.7 to 17.3
|
Adverse Events
ISA 101b + Cemiplimab 350 mg Q3W
Serious events: 34 serious events
Other events: 99 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 participants at risk
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
Infections and infestations
Sepsis
|
2.7%
3/113 • Number of events 3 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Urinary tract infection
|
2.7%
3/113 • Number of events 3 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Urosepsis
|
1.8%
2/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
COVID-19
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Kidney infection
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Osteomyelitis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Skin bacterial infection
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Skin infection
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Vaginal infection
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Colitis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
2/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Renal and urinary disorders
Renal haematoma
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Renal and urinary disorders
Urogenital fistula
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
3/113 • Number of events 3 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.7%
3/113 • Number of events 3 • From signing of informed consent to end of study (~up to 28 months)
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
General physical health deterioration
|
0.88%
1/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Malaise
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Product Issues
Device dislocation
|
1.8%
2/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
1/113 • Number of events 2 • From signing of informed consent to end of study (~up to 28 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
2/113 • Number of events 3 • From signing of informed consent to end of study (~up to 28 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Psychiatric disorders
Mental disorder
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
Vascular disorders
Lymphoedema
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Asthenia
|
0.88%
1/113 • Number of events 1 • From signing of informed consent to end of study (~up to 28 months)
|
Other adverse events
| Measure |
ISA 101b + Cemiplimab 350 mg Q3W
n=113 participants at risk
A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug
|
|---|---|
|
General disorders
Injection site reaction
|
38.9%
44/113 • Number of events 58 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Pyrexia
|
19.5%
22/113 • Number of events 32 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Fatigue
|
18.6%
21/113 • Number of events 25 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Asthenia
|
13.3%
15/113 • Number of events 16 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Oedema peripheral
|
7.1%
8/113 • Number of events 8 • From signing of informed consent to end of study (~up to 28 months)
|
|
General disorders
Influenza like illness
|
6.2%
7/113 • Number of events 11 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Nausea
|
23.9%
27/113 • Number of events 35 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
17/113 • Number of events 22 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
15/113 • Number of events 16 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Constipation
|
12.4%
14/113 • Number of events 15 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
14.2%
16/113 • Number of events 20 • From signing of informed consent to end of study (~up to 28 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
6/113 • Number of events 6 • From signing of informed consent to end of study (~up to 28 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
27.4%
31/113 • Number of events 51 • From signing of informed consent to end of study (~up to 28 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
10/113 • Number of events 11 • From signing of informed consent to end of study (~up to 28 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
11/113 • Number of events 13 • From signing of informed consent to end of study (~up to 28 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
10/113 • Number of events 10 • From signing of informed consent to end of study (~up to 28 months)
|
|
Endocrine disorders
Hypothyroidism
|
8.0%
9/113 • Number of events 9 • From signing of informed consent to end of study (~up to 28 months)
|
|
Endocrine disorders
Hyperthyroidism
|
8.0%
9/113 • Number of events 9 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
Urinary tract infection
|
8.8%
10/113 • Number of events 13 • From signing of informed consent to end of study (~up to 28 months)
|
|
Infections and infestations
COVID-19
|
5.3%
6/113 • Number of events 6 • From signing of informed consent to end of study (~up to 28 months)
|
|
Investigations
Blood creatinine increased
|
7.1%
8/113 • Number of events 11 • From signing of informed consent to end of study (~up to 28 months)
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
7/113 • Number of events 9 • From signing of informed consent to end of study (~up to 28 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
7/113 • Number of events 9 • From signing of informed consent to end of study (~up to 28 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.4%
14/113 • Number of events 16 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
8/113 • Number of events 12 • From signing of informed consent to end of study (~up to 28 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
6/113 • Number of events 6 • From signing of informed consent to end of study (~up to 28 months)
|
|
Nervous system disorders
Headache
|
10.6%
12/113 • Number of events 14 • From signing of informed consent to end of study (~up to 28 months)
|
|
Psychiatric disorders
Insomnia
|
7.1%
8/113 • Number of events 8 • From signing of informed consent to end of study (~up to 28 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
7/113 • Number of events 7 • From signing of informed consent to end of study (~up to 28 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.3%
6/113 • Number of events 7 • From signing of informed consent to end of study (~up to 28 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
7/113 • Number of events 8 • From signing of informed consent to end of study (~up to 28 months)
|
|
Vascular disorders
Hypotension
|
5.3%
6/113 • Number of events 6 • From signing of informed consent to end of study (~up to 28 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
6/113 • Number of events 6 • From signing of informed consent to end of study (~up to 28 months)
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
6/113 • Number of events 9 • From signing of informed consent to end of study (~up to 28 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