A Phase 1 interventional study of Axalimogene filolisbac in Effects of Immunotherapy, Metastatic/Recurrent Cervical Cancer and Cervical Adenocarcinoma, sponsored by Advaxis, Inc.. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Advaxis, Inc. · Phase 1, Interventional, and Treatment
To evaluate the tolerability and safety of axalimogene filolisbac 1 x 10\^10 colony forming units (cfu) administered with prophylactic premedication in repeating 3-dose study cycles in women with persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
In this Phase 1, open-label, multicenter dose-escalation study, participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac every 3 weeks in repeating 12-week treatment cycles. Axalimogene filolisbac was administered intravenously (IV) on Day 1 of Weeks 1, 4, 7, and 10 of each cycle. Participants received a prophylactic regimen that was completed prior to each axalimogene filolisbac infusion to mitigate and manage potential immune responses seen with immunotherapy administration. The pretreatment prophylaxis regimen included commercially available antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), antiemetics, histamine H2-receptor antagonists, and IV hydration. Additional NSAID doses and antiemetic administration were given post initial administration on Day 1 and Day 2, at the discretion of the investigator.
Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
Axalimogene filolisbac doses were to be escalated/de-escalated in the standard 3 + 3 fashion, starting with 5x10\^9 cfu to a maximum dose level of 1x10\^10 cfu. Dose cohorts of 3 participants each were to be treated. All decisions regarding dose escalation/de-escalation were made by the sponsor in consultation with investigators. In the absence of dose-limiting toxicity (DLT) assessed during the first 28 days in Cycle 1, the dose was to be escalated to the next dose level for the next 3 participants. If DLT was seen in 1 of 3 participants, another 3 participants were to be treated at that same dose. If DLT was seen in 2 of 6 participants, then that dose level was considered the Maximum Tolerated Dose (MTD) and the previous dose level was selected as the Recommended Phase 2 dose (RP2D). Specific hematologic and non-hematologic DLT criteria were prospectively defined in protocol. The RP2D was to be selected based on an observed DLT rate of \<33%.
Additional participants were to be enrolled into an expansion cohort to allow approximately 15 participants to be treated at that dose level.
Treatment cycles were repeated at the RP2D (or less) for an individual participant until a discontinuation criterion was met. Discontinuation criteria included documented disease progression, intolerable side effects not resolved with dose reduction or change in premedication or the participant completed 1 cycle of treatment post observation of complete response (CR per RECIST 1.1 and immune-realted complete response [irCR] per irRECIST). Participants who experienced a DLT during the dose-escalation portion of the study or experienced events meeting the definition of a DLT as described in the protocol in any subsequent treatment cycle were to be discontinued from study treatment. However, if a participant who experienced a DLT showed significant response to axalimogene filolisbac, the participant could receive subsequent axalimogene filolisbac treatment at a lower dose level following discussion and agreement between the investigator and sponsor.
Efficacy was assessed by tumor imaging at the end of every cycle. Safety was assessed by analyzing treatment-related adverse events (AEs), changes in physical examinations, vital sign measurements, and clinical laboratory abnormalities. All toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
After the study treatment period, all participants were to participate in a 3-year Lm surveillance monitoring period that included a 6-month course of antibiotics to be initiated 72 hours after completion of treatment or immediately following study discontinuation and monitoring (Complete blood count [CBC], comprehensive metabolic panel, and blood cultures for the detection of Lm) every 3 months (±2 weeks).
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Advaxis, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 colony forming units (cfu) by intravenous infusion, over 60 minutes duration, every 3 weeks (Q3W) in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
Biological: Axalimogene filolisbac
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
Biological: Axalimogene filolisbac
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
Biological: Axalimogene filolisbac
Also known as: ADXS11-001
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy. Hematologic: 1. Grade 4 hematologic toxicity. 2. Febrile neutropenia, defined as absolute neutrophil count (ANC) \< 1000/mm\^3 with a single temperature of \>38.3° C (101° F) or a sustained temperature of \>38° C (100.4° F) for more than 1 hour. 3. Grade 3 thrombocytopenia lasting \>72 hours. 4. Grade 4 thrombocytopenia. Non-Hematologic: 1. ≥Grade 3 non-hematologic toxicity 2. Grade 3 non hematologic laboratory values. 3. Listeremia: positive blood cultures along with persistent (for 72 hours post dose) symptoms consistent with listeremia (e.g., fever and muscle aches, often preceded by diarrhea or other gastrointestinal symptoms). 4. ≥Grade 3 flu-like symptoms or cytokine release symptoms that persist for \>24 hours after study treatment administration despite symptomatic treatment.
Time frame: Up to 28 days in Cycle 1 (12 weeks cycle)
Listeria Monocytogenes Surveillance
Number of participants with delayed listeria infection was reported.
Time frame: Up to 120 days post dose
Number of Participants With Adverse Events
Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment \& which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable \& unintended sign, 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 of a preexisting condition that was temporally associated with the use of study treatment. AE with onset on or after the date of first administration of the study treatment until the end of the Listeria Monocytogenes (Lm) surveillance period.
Time frame: From first dose up to 2.3 years
Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ORR as per RECIST 1.1 was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Time frame: From first dose until end of treatment (Maximum duration: 1.5 years)
Duration of Tumor Response as Per RECIST 1.1
Duration of response as per RECIST 1.1 was defined as the time interval from CR or PR to disease progression or death. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Progressive disease (PD) was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression .Kaplan-Meier method was used to estimate median and 95% confidence interval (CI).
Time frame: From first objective response to disease progression or death (Maximum duration: 1.5 years)
Progression Free Survival (PFS) as Per RECIST 1.1
PFS as per RECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. PD was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression.The Kaplan-Meier method was used to estimate median and 95% CI.
Time frame: From study enrollment to disease progression or death (Maximum duration: 1.5 years)
ORR as Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
ORR as per irRECIST was defined as the percent of participants who achieved immune response complete response (irCR) or immune response partial response (irPR). irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline.
Time frame: From first dose until end of treatment (Maximum duration was 1.5 years)
Duration of Tumor Response as Per irRECIST
Duration of response as per irRECIST 1.1 was defined as the time interval from irCR or irPR to disease progression or death. irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline. Immune response progressive disease (irPD) was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
Time frame: From first objective response to disease progression or death (Maximum duration: 1.5 years)
PFS as Per irRECIST
PFS as per irRECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. irPD was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
Time frame: From study enrollment to disease progression or death (Maximum duration: 1.5 years)
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy were enrolled in this study.
| Milestone | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Started | 1 | 6 | 5 |
| Enrolled participants | 0 | 6 | 6 |
| Treated participants | 1 | 6 | 5 |
| Completed | 0 | 0 | 0 |
| Not completed | 1 | 6 | 5 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Disease progression | 1 | 3 | 4 |
| Withdrew: Withdrawal by subject | 0 | 3 | 0 |
DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy. Hematologic: 1. Grade 4 hematologic toxicity. 2. Febrile neutropenia, defined as absolute neutrophil count (ANC) \< 1000/mm\^3 with a single temperature of \>38.3° C (101° F) or a sustained temperature of \>38° C (100.4° F) for more than 1 hour. 3. Grade 3 thrombocytopenia lasting \>72 hours. 4. Grade 4 thrombocytopenia. Non-Hematologic: 1. ≥Grade 3 non-hematologic toxicity 2. Grade 3 non hematologic laboratory values. 3. Listeremia: positive blood cultures along with persistent (for 72 hours post dose) symptoms consistent with listeremia (e.g., fever and muscle aches, often preceded by diarrhea or other gastrointestinal symptoms). 4. ≥Grade 3 flu-like symptoms or cytokine release symptoms that persist for \>24 hours after study treatment administration despite symptomatic treatment.
| Participants | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 1 | 0 |
Number of participants with delayed listeria infection was reported.
| participants | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Listeria Monocytogenes Surveillance | 0 | 0 | 0 |
Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment \& which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable \& unintended sign, 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 of a preexisting condition that was temporally associated with the use of study treatment. AE with onset on or after the date of first administration of the study treatment until the end of the Listeria Monocytogenes (Lm) surveillance period.
| Participants | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Number of Participants With Adverse Events | 1 | 6 | 5 |
ORR as per RECIST 1.1 was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
| percentage of participants | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) | 20.00 (0.51 to 71.64) |
Duration of response as per RECIST 1.1 was defined as the time interval from CR or PR to disease progression or death. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Progressive disease (PD) was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression .Kaplan-Meier method was used to estimate median and 95% confidence interval (CI).
| days | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Duration of Tumor Response as Per RECIST 1.1 | NA (NA to NA) | NA (NA to NA) | 269.0 (NA to NA) |
PFS as per RECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. PD was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression.The Kaplan-Meier method was used to estimate median and 95% CI.
| days | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Progression Free Survival (PFS) as Per RECIST 1.1 | 124.0 (NA to NA) | 85.0 (80.0 to 99.0) | 176.5 (78.0 to 528.0) |
ORR as per irRECIST was defined as the percent of participants who achieved immune response complete response (irCR) or immune response partial response (irPR). irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline.
| percentage of participants | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| ORR as Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) | 20.00 (0.51 to 71.64) |
Duration of response as per irRECIST 1.1 was defined as the time interval from irCR or irPR to disease progression or death. irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline. Immune response progressive disease (irPD) was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
| days | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| Duration of Tumor Response as Per irRECIST | NA (NA to NA) | NA (NA to NA) | 269.0 (NA to NA) |
PFS as per irRECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. irPD was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
| days | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| PFS as Per irRECIST | 124.0 (NA to NA) | 85.0 (80.0 to 99.0) | 176.5 (78.0 to 528.0) |
Collected over 2 years and 3 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Axalimogene Filolisbac 1x10^9 Cfu | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Axalimogene Filolisbac 5x10^9 Cfu | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Axalimogene Filolisbac 1x10^10 Cfu | 2/5 (40%) | 1/5 (20%) | 5/5 (100%) |
| Event | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| HypotensionVascular disorders | 1/1 | 1/6 | 0/5 |
| Rectal haemorrhageGastrointestinal disorders | 0/1 | 0/6 | 1/5 |
| Vaginal haemorrhageReproductive system and breast disorders | 0/1 | 0/6 | 1/5 |
| EmbolismVascular disorders | 0/1 | 0/6 | 1/5 |
| AnaemiaBlood and lymphatic system disorders | 0/1 | 1/6 | 0/5 |
| Abdominal painGastrointestinal disorders | 0/1 | 1/6 | 0/5 |
| Urinary tract obstructionRenal and urinary disorders | 0/1 | 1/6 | 0/5 |
| Event | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu |
|---|---|---|---|
| TachycardiaCardiac disorders | 1/1 | 2/6 | 2/5 |
| PyrexiaGeneral disorders | 1/1 | 2/6 | 4/5 |
| Vulvovaginal discomfortReproductive system and breast disorders | 1/1 | 0/6 | 0/5 |
| HypotensionVascular disorders | 1/1 | 4/6 | 1/5 |
| Pelvic painReproductive system and breast disorders | 1/1 | 1/6 | 1/5 |
| ChillsGeneral disorders | 0/1 | 4/6 | 3/5 |
| NauseaGastrointestinal disorders | 0/1 | 2/6 | 3/5 |
| PainGeneral disorders | 0/1 | 0/6 | 3/5 |
| AnaemiaBlood and lymphatic system disorders | 0/1 | 3/6 | 1/5 |
| Abdominal painGastrointestinal disorders | 0/1 | 3/6 | 0/5 |
The All Treated population included participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu | Total |
|---|---|---|---|---|
| Mean | 39.0 | 51.3 ± 11.22 | 59.2 ± 19.10 | 53.6 ± 15.04 |
| Sex: Female, Male(Participants) | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu | Total |
|---|---|---|---|---|
| Female | 1 | 6 | 5 | 12 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 1 | 6 | 4 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Axalimogene Filolisbac 1x10^9 Cfu | Axalimogene Filolisbac 5x10^9 Cfu | Axalimogene Filolisbac 1x10^10 Cfu | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 3 | 5 |
| White | 1 | 4 | 2 | 7 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2015 to primary completion in Mar 2017, 24 months.
Results were first posted in May 2024, 7 years 2 months after primary completion.
Of 84 industry-sponsored phase 1 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 57. This study's 24 months is below that.
Counting every sponsor, half of 142 studies reached it within 48 months; a quarter within 27 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Axalimogene filolisbac
Advaxis, Inc.