Phase 1
N=12
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
Effects of Immunotherapy · Metastatic/Recurrent Cervical Cancer · Cervical Adenocarcinoma · Cervical Adenosquamous Cell Carcinoma · Cervical Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02164461 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Axalimogene filolisbac (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Advaxis, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 1; 0 | — |
| PRIMARY Listeria Monocytogenes Surveillance |
0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events |
1; 6; 5 | — |
| SECONDARY Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
0.00; 0.00; 20.00 | — |
| SECONDARY Duration of Tumor Response as Per RECIST 1.1 |
NA; NA; 269.0 | — |
| SECONDARY Progression Free Survival (PFS) as Per RECIST 1.1 |
124.0; 85.0; 176.5 | — |
| SECONDARY ORR as Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) |
0.00; 0.00; 20.00 | — |
| SECONDARY Duration of Tumor Response as Per irRECIST |
NA; NA; 269.0 | — |
| SECONDARY PFS as Per irRECIST |
124.0; 85.0; 176.5 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02164461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.