Clinical trial · Interventional
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)
NCT02164461CI-TRIAL-00077297completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Cell Carcinoma | Cervical Adenosquamous Carcinoma | ALIAS | 0.90 |
| Cervical Small Cell Carcinoma | Cervical Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Effects of Immunotherapy | — | UNRESOLVED | — |
| Metastatic/Recurrent Cervical Cancer | — | UNRESOLVED | — |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axalimogene filolisbac | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Axalimogene filolisbac 1x10^9 cfu
- description
- 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.
- interventionNames
- Biological: Axalimogene filolisbac
- type
- EXPERIMENTAL
- label
- Axalimogene filolisbac 5x10^9 cfu
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.