Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
A Phase 1 Study Evaluating High Dose ADXS11-001 Treatment in Women With Carcinoma of the Cervix (ADXS001-07)
1 other identifier
interventional
12
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2015
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedStudy Start
First participant enrolled
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2017
CompletedResults Posted
Study results publicly available
May 20, 2024
CompletedMay 20, 2024
December 1, 2023
2 years
June 13, 2014
February 15, 2023
December 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Up to 28 days in Cycle 1 (12 weeks cycle)
Listeria Monocytogenes Surveillance
Number of participants with delayed listeria infection was reported.
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.
From first dose up to 2.3 years
Secondary Outcomes (6)
Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
From first dose until end of treatment (Maximum duration: 1.5 years)
Duration of Tumor Response as Per RECIST 1.1
From first objective response to disease progression or death (Maximum duration: 1.5 years)
Progression Free Survival (PFS) as Per RECIST 1.1
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)
From first dose until end of treatment (Maximum duration was 1.5 years)
Duration of Tumor Response as Per irRECIST
From first objective response to disease progression or death (Maximum duration: 1.5 years)
- +1 more secondary outcomes
Study Arms (3)
Axalimogene filolisbac 1x10^9 cfu
EXPERIMENTALParticipants 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.
Axalimogene filolisbac 5x10^9 cfu
EXPERIMENTALParticipants 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.
Axalimogene filolisbac 1x10^10 cfu
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Participants with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy).
- Participants who have received no more than 1 prior cytotoxic treatment regimen.
- Participant may have received ≤2 prior regimens for the treatment of their metastatic disease.
- Participant is able to provide written informed consent.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You may not qualify if:
- In the opinion of the investigator, participant has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy.
- Participant has received chemotherapy and/or radiation therapy (except palliative radiation therapy for disease-related pain) within ≤2 weeks of first axalimogene filolisbac infusion.
- Participant has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
- Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any participant who has any other device and/or implant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advaxis, Inc.lead
Study Sites (2)
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Charlottesville, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sumitra Sheeri
- Organization
- Advaxis, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 16, 2014
Study Start
March 4, 2015
Primary Completion
March 8, 2017
Study Completion
March 8, 2017
Last Updated
May 20, 2024
Results First Posted
May 20, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share