A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anor… (NCT02399813) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
United States36 participantsStarted 2016-06-02
Plain-language summary
This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must have cancer of the anal canal OR rectal cancer.
* Must have metastatic disease or persistent/recurrent loco-regional disease
* Prior Therapy: may have received \<2 regimens for disease in the metastatic setting. At least one line of therapy.
* Be willing and able to provide written informed consent for the trial.
* Be ≥18 years of age on day of signing informed consent.
* Have measurable disease based on response evaluation criteria in solid tumors (RECIST) 1.1
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrate adequate organ function as defined in protocol.
* Females cannot be pregnant or breastfeeding and must take two methods of birth control
Exclusion Criteria:
* Has not recovered (for example, Grade ≤1 or at baseline) from adverse events (AEs), with the exception of alopecia or Grade ≤2 neuropathy, due to a previously administered agent
* Has a diagnosis of immunodeficiency
* Has known additional malignancy that is progressing or requires active treatment. Treatment of an additional malignancy with chemotherapy, immunotherapy, biologic or hormonal therapy must have occurred 2 years prior. Concurrent use of hormones for non-cancer-related conditions (for example, insulin for diabetes and hormone replacement therapy) is acceptable
* Note: Local treatment of isolated lesions for palliative intent (for example, by local surgery or radiotherapy), basal cell carcinoma of the skin, or squamous cell carci…
What they're measuring
1
Percentage of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: From the first dose until progression or death (maximum duration: 68 weeks)
2
Progression Free Survival
Timeframe: From the first dose until progression or death (maximum duration: 68 weeks)