Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Anus Diseases

Anal Cancer

Participants received intravenous (IV) infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 colony forming units (cfu) for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.

Axalimogene filolisbac

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.

A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal

Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal

Best response was defined as achievement of complete response (CR) or partial response (PR) per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progression free survival was defined as the time from treatment start until disease progression or death whichever occurred earlier. Participants who have not progressed or who are still alive at the time of evaluation will be censored for the analysis. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Kaplan-Meier method was used for estimating progression free survival.

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an adverse event.

Advaxis, Inc.

All Treated population: Participants who received at least one dose of axalimogene filolisbac.

Participants received IV infusion of axalimogene filolisbac administered over 60 minutes every 3 weeks at a dose of 1 x 10\^9 cfu for up to 2 years or until a discontinuation criterion was met (documented progression, unacceptable adverse events, withdrawn due to investigator's discretion, participant withdraws consent, pregnancy or noncompliance with study procedures or treatments). A treatment cycle was defined as 9 weeks in duration.

Axalimogene Filolisbac

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Sumitra Sheeri

Participants in the All Treated population were analyzed.

Percentage of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Progression Free Survival

Number of Participants With Adverse Events

Overall Study

Spots Global Cancer Trial Database for A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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