Trial Outcomes & Findings for A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal (NCT NCT02399813)
NCT ID: NCT02399813
Last Updated: 2023-03-20
Results Overview
Best response was defined as achievement of complete response (CR) or partial response (PR) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From the first dose until progression or death (maximum duration: 68 weeks)
Results posted on
2023-03-20
Participant Flow
Participant milestones
| Measure |
Axalimogene Filolisbac
Participants received intravenous (IV) infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 colony forming units (cfu) for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Axalimogene Filolisbac
Participants received intravenous (IV) infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 colony forming units (cfu) for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
|
Overall Study
Progressive Disease-Radiographic
|
2
|
|
Overall Study
Death
|
20
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Initiating a Non-Study Cancer Treatment
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other than specified
|
5
|
Baseline Characteristics
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
Baseline characteristics by cohort
| Measure |
Axalimogene Filolisbac
n=36 Participants
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
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Age, Continuous
|
60.0 years
STANDARD_DEVIATION 7.86 • n=39 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From the first dose until progression or death (maximum duration: 68 weeks)Population: Participants in the All Treated population were analyzed.
Best response was defined as achievement of complete response (CR) or partial response (PR) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Axalimogene Filolisbac
n=36 Participants
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
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Percentage of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
2.8 percentage of participants
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PRIMARY outcome
Timeframe: From the first dose until progression or death (maximum duration: 68 weeks)Population: Participants in the All Treated population were analyzed.
Progression free survival was defined as the time from treatment start until disease progression or death whichever occurred earlier. Participants who have not progressed or who are still alive at the time of evaluation will be censored for the analysis. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Kaplan-Meier method was used for estimating progression free survival.
Outcome measures
| Measure |
Axalimogene Filolisbac
n=36 Participants
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
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Progression Free Survival
|
2.0 months
Interval 1.8 to 2.1
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SECONDARY outcome
Timeframe: From the first dose until end of study (maximum duration: 72 weeks)Population: Participants in the All Treated population were analyzed.
An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an adverse event.
Outcome measures
| Measure |
Axalimogene Filolisbac
n=36 Participants
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
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Number of Participants With Adverse Events
|
36 Participants
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Adverse Events
Axalimogene Filolisbac
Serious events: 15 serious events
Other events: 36 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Axalimogene Filolisbac
n=36 participants at risk
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Ascites
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Proctalgia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Disease progression
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Oedema peripheral
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Immune system disorders
Cytokine release syndrome
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Cellulitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood bilirubin increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Encephalopathy
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Hallucination
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Hypotension
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Thrombosis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
Other adverse events
| Measure |
Axalimogene Filolisbac
n=36 participants at risk
Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.
|
|---|---|
|
Cardiac disorders
Palpitations
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.8%
10/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Cardiac disorders
Tachycardia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Eye disorders
Vision blurred
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
6/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.6%
11/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Ascites
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Constipation
|
30.6%
11/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.8%
10/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Nausea
|
58.3%
21/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Oesophagitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Oral pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Retching
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Stomatitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
12/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Asthenia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Chills
|
69.4%
25/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Disease progression
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Fatigue
|
38.9%
14/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Generalised oedema
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Hypothermia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Influenza like illness
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Oedema peripheral
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Pain
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
General disorders
Pyrexia
|
55.6%
20/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Hepatobiliary disorders
Cholangitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Immune system disorders
Cytokine Release Syndrome
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Cellulitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Cystitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Lung Infection
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Oral herpes
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Pneumonia
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
22.2%
8/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Rectal injury
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood bilirubin increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood creatine increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood creatinine increased
|
22.2%
8/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Body temperature increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Hepatic enzyme increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
International normalised ratio increased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Neutrophil count decreased
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Platelet count decreased
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Transaminases increased
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
Weight decreased
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Investigations
White blood cell count decreased
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
9/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.4%
7/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Dizziness
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Encephalopathy
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Headache
|
38.9%
14/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Hypersomnia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Sciatica
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Abnormal dreams
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Anxiety
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Confusional state
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Hallucination
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Psychiatric disorders
Restlessness
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Haematuria
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
5/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.8%
10/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
4/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
3/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Embolism
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Flushing
|
5.6%
2/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Hypertension
|
19.4%
7/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Hypotension
|
47.2%
17/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
|
Vascular disorders
Thrombosis
|
2.8%
1/36 • From the first dose until end of study (maximum duration: 72 weeks)
All Treated population: Participants who received at least one dose of axalimogene filolisbac.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall seek the Sponsor's written approval for study results publication which shall not be unreasonably withheld. Such publication by Institution and/or Investigator may be no earlier than after a cooperative publication has been published with Sponsor or 1 year from date of completion or termination of the Study \& only after review and comment by Sponsor. Institution agrees to provide Sponsor a copy of proposed publication at least 60 days prior to submission to a publisher.
- Publication restrictions are in place
Restriction type: OTHER