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

NCT02399813 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ADXS001-062015-001053-33
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Anal Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

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

  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.

  From the first dose until progression or death (maximum duration: 68 weeks)

• Progression Free Survival

  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.

  From the first dose until progression or death (maximum duration: 68 weeks)

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  From the first dose until end of study (maximum duration: 72 weeks)

Study Arms (1)

Axalimogene filolisbac

EXPERIMENTAL

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.

Drug: Axalimogene filolisbac

Interventions

Axalimogene filolisbac DRUG

Also known as: ADXS11-001

Axalimogene filolisbac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically cured is acceptable
• Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided the metastases are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to the first dose of study treatment
• Has concurrent unstable or uncontrolled medical condition (example, active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which in the opinion of the investigator, could compromise the patient or the study
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
• Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
• Participants that require intermittent use of inhaled steroids, bronchodilators or local steroid injections may be allowed with sponsor approval.
• Participants with hypothyroidism stable on hormone replacement or Sjorgen's Syndrome will not be excluded from the study
• Has an active infection requiring systemic therapy. Prior to dosing with study treatment(s), the subject must be at least 5 half-lives from their last dose of antibiotic
• Has any other serious or uncontrolled physical or mental condition/disease that, as judged by the investigator, could place the patient at higher risk derived from his/her participation in the study, could confound results of the study, or would be likely to prevent the patient from complying with the requirements of the study or completing the study.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Participant has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (examples, 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 (example, Port-a-Cath or Mediport) are permitted. Participants with any other devices or implants must be approved by Sponsor prior to participation

Sponsors & Collaborators

• Advaxis, Inc.: lead

Study Sites (10)

Unknown Facility

Duarte, California, United States

Location

Unknown Facility

New Haven, Connecticut, 06510, United States

Location

Indiana University

Indianapolis, Indiana, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Fox Chase

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Eng C, Fakih M, Amin M, Morris V, Hochster HS, Boland PM, Uronis H. A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer. Oncotarget. 2020 Apr 14;11(15):1334-1343. doi: 10.18632/oncotarget.27536. eCollection 2020 Apr 14.

  PMID: 32341753 RESULT

MeSH Terms

Conditions

Anus Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Results Point of Contact

• Title: Sumitra Sheeri
• Organization: Advaxis, Inc.

sheeri@advaxis.com

609-423-2528

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: June 2, 2016
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Locations

US (10)