Trial Outcomes & Findings for UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (NCT NCT04382664)
NCT ID: NCT04382664
Last Updated: 2025-01-14
Results Overview
Compare progression free survival (PFS) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Time from randomization to progressive disease (PD) or death from any cause (approximately 44 months)
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
UV1 Vaccination + Nivolumab and Ipilimumab
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination includes sargramostim (75 μg), used as a vaccine adjuvant, and the UV1 vaccine (300 μg). Both injected intradermally.
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Nivolumab and Ipilimumab
Nivolumab and ipilimumab
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
78
|
|
Overall Study
COMPLETED
|
75
|
76
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
Baseline characteristics by cohort
| Measure |
UV1 Vaccination + Nivolumab and Ipilimumab
n=78 Participants
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination includes sargramostim (75 μg), used as a vaccine adjuvant, and the UV1 vaccine (300 μg). Both injected intradermally.
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Nivolumab and Ipilimumab
n=78 Participants
nivolumab and ipilimumab
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to progressive disease (PD) or death from any cause (approximately 44 months)Population: Intention To Treat population (IIT)
Compare progression free survival (PFS) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab
Outcome measures
| Measure |
UV1 Vaccination + Nivolumab and Ipilimumab
n=78 Participants
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination includes sargramostim (75 μg), used as a vaccine adjuvant, and the UV1 vaccine (300 μg). Both injected intradermally.
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Nivolumab and Ipilimumab
n=78 Participants
Nivolumab and ipilimumab
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
|---|---|---|
|
PFS Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (by Blinded Independent Central Review (BICR)
|
35 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Time from randomization to death from any cause /follow-up until 70 PFS events/18 months post rand, approximately 44 months.Compare Overall Survival of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Number of complete and partial responses during the study, approximately 44 months.Compare the objective response rate (ORR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first CR or PR to PD or death from any cause, approximately 44 months.Compare duration of response (DOR) of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization to end of study, approximately 47 months.Compare the safety of UV1 vaccination in combination with nivolumab and ipilimumab to that of nivolumab and ipilimumab. Safety will be listed and summarized descriptively by treatment arm comparing number of participants with observation and changes from baseline and at each visit related to AEs, deaths, vital signs (weight (kg), systolic and diastolic blood pressure (mmHg), pulse rate (bpm), body temperature (°C)), laboratory assessments and ECOG performance status (Grade 0 - Grade 5).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from randomization to end of study to readout of primary objectives, approximately 44 months.To elucidate the immunological mechanisms underlying the interplay between immune activation provoked by UV1 vaccination and inhibition of tumor resistance mechanisms and peripheral immune tolerance induced by checkpoint blockade and how biological factors affect the efficacy of the combination therapy. This will be evaluated by change in immune- and tumor-related gene, cell, and protein profiles in blood over time in both treatment arms (analysis of plasma proteins, cell-free plasma DNA, and cellular genomic DNA).
Outcome measures
Outcome data not reported
Adverse Events
UV1 Vaccination + Nivolumab and Ipilimumab
Serious events: 40 serious events
Other events: 76 other events
Deaths: 22 deaths
Nivolumab and Ipilimumab
Serious events: 43 serious events
Other events: 78 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
UV1 Vaccination + Nivolumab and Ipilimumab
n=76 participants at risk
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination includes sargramostim (75 μg), used as a vaccine adjuvant, and the UV1 vaccine (300 μg). Both injected intradermally.
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Nivolumab and Ipilimumab
n=78 participants at risk
Nivolumab and ipilimumab
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Cardiac disorders
Myocarditis
|
2.6%
2/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Endocrine disorders
Hypophysitis
|
1.3%
1/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Endocrine disorders
Adrenal insufficiency
|
2.6%
2/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.00%
0/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Endocrine disorders
Addisons disease
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Eye disorders
Vision blurred
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Gastrointestinal disorders
Colitis
|
5.3%
4/76 • 44 months
|
9.0%
7/78 • 44 months
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
6.6%
5/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
3/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Gastrointestinal disorders
Enteritis
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
2.6%
2/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Gastrointestinal disorders
Duodenitis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
General disorders
Pyrexia
|
5.3%
4/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Fatigue
|
2.6%
2/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
General physical health deterioration
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Malaise
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
5.3%
4/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
1/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Immune system disorders
Anaphylactic reaction
|
2.6%
2/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Immune system disorders
Anaphylactic shock
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Immune system disorders
Cytokine release syndrome
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Immune system disorders
Infusion related reaction
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Pneumonia
|
3.9%
3/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
COVID-19
|
2.6%
2/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Infection
|
1.3%
1/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Infections and infestations
Sepsis
|
2.6%
2/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Biliary sepsis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Bronchitis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Influenza
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Localised infection
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Oral candidiasis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Infections and infestations
Wound infection
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Investigations
Respiratory rate increased
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Investigations
Transaminases increased
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Investigations
Weight decreased
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Headache
|
0.00%
0/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Nervous system disorders
Guillain-Barre syndrome
|
1.3%
1/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Neuritis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Psychiatric disorders
Confusional state
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
2/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.00%
0/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/76 • 44 months
|
0.00%
0/78 • 44 months
|
Other adverse events
| Measure |
UV1 Vaccination + Nivolumab and Ipilimumab
n=76 participants at risk
UV1 vaccination + nivolumab and ipilimumab
UV1 vaccination includes sargramostim (75 μg), used as a vaccine adjuvant, and the UV1 vaccine (300 μg). Both injected intradermally.
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
Nivolumab and Ipilimumab
n=78 participants at risk
Nivolumab and ipilimumab
Ipilimumab: Ipilimumab is dosed according to label.
Nivolumab: Nivolumab is dosed according to label.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
4/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Cardiac disorders
Cardiac disorders
|
10.5%
8/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Endocrine disorders
Hyperthyroidism
|
14.5%
11/76 • 44 months
|
10.3%
8/78 • 44 months
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
9/76 • 44 months
|
12.8%
10/78 • 44 months
|
|
Endocrine disorders
Hypophysitis
|
2.6%
2/76 • 44 months
|
11.5%
9/78 • 44 months
|
|
Endocrine disorders
Adrenal insufficiency
|
5.3%
4/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Eye disorders
Vision blurred
|
2.6%
2/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Gastrointestinal disorders
rfw
|
34.2%
26/76 • 44 months
|
26.9%
21/78 • 44 months
|
|
Gastrointestinal disorders
Diarrhoea
|
31.6%
24/76 • 44 months
|
28.2%
22/78 • 44 months
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
13/76 • 44 months
|
16.7%
13/78 • 44 months
|
|
Gastrointestinal disorders
Constipation
|
14.5%
11/76 • 44 months
|
10.3%
8/78 • 44 months
|
|
Gastrointestinal disorders
Colitis
|
6.6%
5/76 • 44 months
|
15.4%
12/78 • 44 months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
8/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
9.2%
7/76 • 44 months
|
7.7%
6/78 • 44 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
2/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
4/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
4/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
General disorders
Fatigue
|
40.8%
31/76 • 44 months
|
42.3%
33/78 • 44 months
|
|
General disorders
Pyrexia
|
27.6%
21/76 • 44 months
|
12.8%
10/78 • 44 months
|
|
General disorders
Injection site erythema
|
17.1%
13/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Injection site reaction
|
14.5%
11/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Oedema peripheral
|
9.2%
7/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
General disorders
Chills
|
5.3%
4/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
General disorders
Influenza like illness
|
5.3%
4/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
General disorders
Injection site pain
|
5.3%
4/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
General disorders
Vaccination site hyperaesthesia
|
5.3%
4/76 • 44 months
|
0.00%
0/78 • 44 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
7.9%
6/76 • 44 months
|
10.3%
8/78 • 44 months
|
|
Hepatobiliary disorders
Hepatitis
|
5.3%
4/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Immune system disorders
Infusion related reaction
|
7.9%
6/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Infections and infestations
COVID-19
|
5.3%
4/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Infections and infestations
Oral candidiasis
|
6.6%
5/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Infections and infestations
Pneumonia
|
6.6%
5/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Investigations
Alanine aminotransferase increased
|
14.5%
11/76 • 44 months
|
19.2%
15/78 • 44 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
11/76 • 44 months
|
16.7%
13/78 • 44 months
|
|
Investigations
Blood creatinine increased
|
3.9%
3/76 • 44 months
|
9.0%
7/78 • 44 months
|
|
Investigations
Weight decreased
|
5.3%
4/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Investigations
Blood alkaline phosphatase increased
|
3.9%
3/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Investigations
Blood bilirubin increased
|
5.3%
4/76 • 44 months
|
1.3%
1/78 • 44 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.7%
15/76 • 44 months
|
14.1%
11/78 • 44 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
5/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.6%
5/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
4/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
6/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps
|
10.5%
8/76 • 44 months
|
2.6%
2/78 • 44 months
|
|
Nervous system disorders
Headache
|
11.8%
9/76 • 44 months
|
19.2%
15/78 • 44 months
|
|
Psychiatric disorders
Insomnia
|
5.3%
4/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Renal and urinary disorders
Renal and urinary disorders
|
7.9%
6/76 • 44 months
|
3.8%
3/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
6/76 • 44 months
|
15.4%
12/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.9%
6/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
2/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.6%
21/76 • 44 months
|
26.9%
21/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
19/76 • 44 months
|
29.5%
23/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.8%
12/76 • 44 months
|
12.8%
10/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
9.2%
7/76 • 44 months
|
6.4%
5/78 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.3%
1/76 • 44 months
|
5.1%
4/78 • 44 months
|
|
Vascular disorders
Hypertension
|
10.5%
8/76 • 44 months
|
3.8%
3/78 • 44 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place