USA flag

Frequently Asked Questions

If you have questions about the AIM2CERV clinical trial not answered below, we urge you to call the trial information line at +1 844-755-5807 or complete an information request form.

  • What stages of cervical cancer are allowed in the AIM2CERV Study?
    • The study is for stages IB2, IIA2, IIB if the cancer has spread to at least 2 lymph nodes in the pelvis or at least 1 lymph node in the abdomen (near the aorta)
      Stages IIIA, IIIB, and IVA
    • You should discuss your stage information with your doctor if you’re not sure of your cervical cancer stage

    Learn more about the criteria for participating in the AIM2CERV trial.

  • I am in remission, why should I consider AIM2CERV?

    There are benefits for patients to participating even if your cancer is in remission. When cancer recurs in patients who have had HRLACC, there is no effective treatment currently available. The therapy being evaluated in AIM2CERV may reduce the likelihood that the cancer will reoccur and, if cancer does reappear, the additional monitoring may lead to earlier detection.

    Participating in clinical studies may offer you the opportunity to take a more active role in your health, and your contribution to medical research may help others living with cancer.

  • What is axalimogene filolisbac?

    Axalimogen filolisbac (ADXS11-001) is a type of immunotherapy for cancers that were caused by the human papillomavirus, such as cervical cancer. This treatment consists of bacteria that have been altered genetically so that they will not cause a serious infection. The bacteria contain a protein from HPV, which allows them to deliver a signal to the immune system that results in an attack against cervical cancer.

  • Why is it important for women with cervical cancer to know about the AIM2CERV study?
    • There’s a need for better treatment of cervical cancer

      Too many women will experience a return of their cervical cancer following treatment with chemotherapy and radiation. For most patients, there is no effective treatment after cervical cancer returns

    • It’s better to keep cancer from returning, than treating it after it returns; but there’s no known treatment that does this for cervical cancer

      The potential of the AIM2CERV study

      • The AIM2CERV study will test a type of immunotherapy after initial treatment with the combination of chemotherapy and radiation therapy, to determine whether it can delay or prevent the return of cervical cancer in women who are at risk of having their cervical cancer return
      • If this treatment achieves this objective, patients with cervical cancer will have a new treatment option following initial chemotherapy and radiation therapy
  • For this study, which cervical cancer patients are at risk of having their cervical cancer return?
    • Women whose cervical cancer had spread from the cervix to lymph nodes in the pelvis or lymph nodes in the abdomen at the time of diagnosis
    • Women whose cervical cancer had grown big enough to involve the tissues near the cervix such as the vagina and the rectum at the time of diagnosis
  • Is the study treatment safe?

    In previous studies ADXS11-01 was found to be well-tolerated by patients. However, there are some side effects to treatment. About 2 to 4 hours after each treatment, patients have experienced symptoms such as fever, chills, and headache, and low blood pressure. The experience is like having the flu and is caused by your immune system reacting to the drug. The symptoms last for several hours and then go away; usually within about 12 hours after treatment was given.

  • Can anything be done to avoid having those symptoms?

    Yes. Before each treatment, you would be treated with medications that will either prevent those symptoms or make them mild and more tolerable.

  • What is a placebo, and why do you use it in this study?

    A placebo is a substance that looks like a medicine but is a harmless substance. A placebo is used when it is important to prevent patients and their doctors from knowing the identity of the treatment to which the patient was assigned. This is necessary because knowing the type of treatment may consciously or subconsciously influence how the treatment’s effects are evaluated. If that happens, then the results of the assessments would not be reliable.

    A placebo will be used in this study because some of the evaluations are subjective, and may be influenced by knowing whether a patient is on the investigational drug or not. The placebo will only be given to patients who were assigned to be managed according to standard practice, which consists of follow-up visits, but not medication.

    Learn more about clinical trials from the National Institutes of Health website.

  • I’m still being treated with chemotherapy and radiation. Can I start being evaluated for the study?

    You can only begin evaluation for the study after you have completed all your chemotherapy and radiation treatment.

  • How long will the bacteria remain in my system?

    The bacteria will be eliminated from your blood in less than 48 hours.