Trial Outcomes & Findings for Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (NCT NCT03625323)
NCT ID: NCT03625323
Last Updated: 2024-12-18
Results Overview
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months
Results posted on
2024-12-18
Participant Flow
Participant milestones
| Measure |
1st Line NSCLC
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line HNSCC
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
36
|
37
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
114
|
36
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC
Baseline characteristics by cohort
| Measure |
1st Line NSCLC
n=114 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
n=36 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
HNSCC
n=37 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
Total
n=187 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Continuous
|
67 Years
n=5 Participants
|
67 Years
n=7 Participants
|
63 Years
n=5 Participants
|
67 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
178 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Smoking history
Non-smoker
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Smoking history
Ex- or current smoker
|
108 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 monthsORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
| Measure |
1st Line NSCLC
n=114 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
n=36 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
HNSCC
n=37 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
|---|---|---|---|
|
Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)
|
46 Participants
|
3 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 monthsORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
| Measure |
1st Line NSCLC
n=114 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
n=36 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
HNSCC
n=37 Participants
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
|---|---|---|---|
|
Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)
|
40 Participants
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 27 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 27 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 27 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 68 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthOutcome measures
Outcome data not reported
Adverse Events
1st Line NSCLC
Serious events: 50 serious events
Other events: 114 other events
Deaths: 14 deaths
2nd Line NSCLC
Serious events: 7 serious events
Other events: 35 other events
Deaths: 2 deaths
2nd Line HNSCC
Serious events: 20 serious events
Other events: 36 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
1st Line NSCLC
n=114 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
n=36 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line HNSCC
n=37 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.0%
8/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
4/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
2/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.5%
4/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Pneumonia
|
1.8%
2/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
3/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Death (unknown cause)
|
2.6%
3/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
COVID-19
|
1.8%
2/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
2/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
2/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Cardiac disorders
Cardiac failure
|
1.8%
2/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
1/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Gastrointestinal disorders
Constipation
|
0.88%
1/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Nervous system disorders
Seizure
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Respiratory tract infection
|
0.88%
1/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Achromobacter infection
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Bronchitis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Otitis media
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Pleural infection
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Pneumonia viral
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Prostate infection
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Pulmonary sepsis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Sepsis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Septic shock
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.00%
0/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Fatigue
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Gait disturbance
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
General physical health deterioration
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Vascular disorders
Arterial thrombosis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Investigations
Biopsy lymph gland
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Immune system disorders
Hypersensitivity
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
Other adverse events
| Measure |
1st Line NSCLC
n=114 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line NSCLC
n=36 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
2nd Line HNSCC
n=37 participants at risk
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Eftilagimod alpha: APC activator, MHC II agonist, LAG-3 fusion protein
Pembrolizumab: anti-PD-1 antibody
|
|---|---|---|---|
|
General disorders
Asthenia
|
32.5%
37/114 • Up to 27 months
|
22.2%
8/36 • Up to 27 months
|
21.6%
8/37 • Up to 27 months
|
|
General disorders
Fatigue
|
21.9%
25/114 • Up to 27 months
|
19.4%
7/36 • Up to 27 months
|
16.2%
6/37 • Up to 27 months
|
|
General disorders
Pyrexia
|
12.3%
14/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
General disorders
Oedema peripheral
|
9.6%
11/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Injection site pain
|
8.8%
10/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Injection site erythema
|
7.0%
8/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Non-cardiac chest pain
|
7.0%
8/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Injection site reaction
|
6.1%
7/114 • Up to 27 months
|
11.1%
4/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Injection site swelling
|
3.5%
4/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Injection site pruritus
|
3.5%
4/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Chest pain
|
0.88%
1/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
General disorders
Facial pain
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
General disorders
Pain
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
General disorders
Face oedema
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.1%
40/114 • Up to 27 months
|
30.6%
11/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.2%
31/114 • Up to 27 months
|
30.6%
11/36 • Up to 27 months
|
18.9%
7/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
15.8%
18/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.9%
9/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.6%
3/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
6/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.88%
1/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.88%
1/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
19/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Gastrointestinal disorders
Constipation
|
17.5%
20/114 • Up to 27 months
|
11.1%
4/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
18/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
13.5%
5/37 • Up to 27 months
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
12/114 • Up to 27 months
|
11.1%
4/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
7/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
5/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
7/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
2/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
6/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
18/114 • Up to 27 months
|
16.7%
6/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.3%
14/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
13.5%
5/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.4%
13/114 • Up to 27 months
|
11.1%
4/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
8/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.0%
8/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.4%
5/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
8/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.6%
28/114 • Up to 27 months
|
33.3%
12/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.9%
9/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.6%
3/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.5%
4/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.88%
1/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Infections and infestations
Pneumonia
|
8.8%
10/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
4/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
13.5%
5/37 • Up to 27 months
|
|
Infections and infestations
Urinary tract infection
|
5.3%
6/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Infections and infestations
COVID-19
|
6.1%
7/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Bronchitis
|
4.4%
5/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Infections and infestations
Oral candidiasis
|
3.5%
4/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
3/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Infections and infestations
Skin infection
|
4.4%
5/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
2/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Infections and infestations
Rhinitis
|
1.8%
2/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Investigations
Weight decreased
|
5.3%
6/114 • Up to 27 months
|
16.7%
6/36 • Up to 27 months
|
18.9%
7/37 • Up to 27 months
|
|
Investigations
Amylase increased
|
11.4%
13/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
6/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
6/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Investigations
Blood creatinine increased
|
5.3%
6/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.9%
25/114 • Up to 27 months
|
13.9%
5/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.9%
17/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
8/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.88%
1/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Nervous system disorders
Headache
|
6.1%
7/114 • Up to 27 months
|
11.1%
4/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Nervous system disorders
Dizziness
|
6.1%
7/114 • Up to 27 months
|
8.3%
3/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Nervous system disorders
Paraesthesia
|
3.5%
4/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Nervous system disorders
Syncope
|
0.88%
1/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Blood and lymphatic system disorders
Anaemia
|
21.9%
25/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
18.9%
7/37 • Up to 27 months
|
|
Endocrine disorders
Hypothyroidism
|
8.8%
10/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
21.6%
8/37 • Up to 27 months
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
6/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Psychiatric disorders
Insomnia
|
9.6%
11/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
2.7%
1/37 • Up to 27 months
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
7/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.3%
6/114 • Up to 27 months
|
2.8%
1/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
4.4%
5/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Vascular disorders
Hypotension
|
5.3%
6/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
10.8%
4/37 • Up to 27 months
|
|
Vascular disorders
Hypertension
|
3.5%
4/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
8.1%
3/37 • Up to 27 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/114 • Up to 27 months
|
0.00%
0/36 • Up to 27 months
|
5.4%
2/37 • Up to 27 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.88%
1/114 • Up to 27 months
|
5.6%
2/36 • Up to 27 months
|
0.00%
0/37 • Up to 27 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Approval from the Sponsor is required for the PI to publish or disseminate results from the medical investigation.
- Publication restrictions are in place
Restriction type: OTHER