Anal CancerPhase 2NCT02399813
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
A Phase 2 study testing Axalimogene filolisbac in people with Anal Cancer and Rectal Cancer, run by Advaxis, Inc. at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Rectal Cancer
- What is being tested?
- Axalimogene filolisbac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Jun 2016to 3 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Any participant currently requiring or anticipated to require tumor necrosis factor (TNF) blocking agent (example: infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis
- Participants who are currently receiving or who have received any phosphoinositide 3-kinase (PI3K) inhibitor within 30 days prior to registration
- Participant has a contraindication (example: sensitivity/allergy) to trimethoprim/sulfamethoxazole and ampicillin
- Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Has known active hepatitis B or hepatitis C
- Has a known allergy to any component of the study treatment(s) formulations
- Has contraindication to administration of non-steroidal anti-inflammatory drugs (NSAIDs)
- Has undergone a major surgery, including surgery for a new artificial implant and/or medical device which is permitted by the protocol, within 6 weeks prior to the initiation of ADXS11-001 treatment
- Note: If the participant had a major surgery, all toxicities and/or complications from the intervention must have recovered to at least the baseline or Grade 1 prior to the initiation of ADXS11-001 study therapy. Consult with the Sponsor prior to enrolling participants on the study who recently had a major surgery or have a new artificial implant and/or medical device
- In the opinion of the investigator has rapidly progressing disease, OR has life expectancy of <6 months, OR would be unable to receive at least 1 cycle of therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Buffalo, New York
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Durham, North Carolina
Study site
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut, 06510
Fox Chase
Philadelphia, Pennsylvania
Study site
St Louis, Missouri, 63110
About this study
Official title: Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal
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
- Being tested
- Axalimogene filolisbac
- Medical subject headings
- Anus Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axalimogene filolisbacDrug
Also called ADXS11-001
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Axalimogene filolisbac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the first dose until progression or death (maximum duration: 68 weeks)
Secondary outcomes (1)
Number of Participants With Adverse Events
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.
Measured: From the first dose until end of study (maximum duration: 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start2 Jun 2016
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advaxis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399813
- Sponsor's protocol ID
- ADXS001-06
- Other IDs
- 2015-001053-33, 2015
- Status last verified
- Feb 2023
- First submitted
- 23 Mar 2015
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32341753
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal
- ClinicalTrials.gov ID
- NCT02399813
- Acronym / sponsor ID
- ADXS001-06
- Conditions
- Anal Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Advaxis, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axalimogene filolisbac | Experimental | Drug: Axalimogene filolisbacParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axalimogene filolisbacAlso: ADXS11-001 | Drug | Axalimogene filolisbac |
Primary outcome
Percentage of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: From the first dose until progression or death (maximum duration: 68 weeks)
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
Time frame: From the first dose until progression or death (maximum duration: 68 weeks)
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.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: From the first dose until end of study (maximum duration: 72 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32341753Eng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axalimogene filolisbac in people with Anal Cancer and Rectal Cancer, run by Advaxis, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: From the first dose until progression or death (maximum duration: 68 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.