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myCare-101 FAQ

myCare-101 FAQ

General Information

Q: What is myCare-101?

myCare-101 is a usability and utility trial where Cellworks provides reports to oncologists showing results from an individual cancer patient’s therapy biosimulation based on the patient’s NGS report.

Q: What is the purpose of the myCare-101 trial?

The purpose of the myCare-101 trial is to determine how valuable and actionable Cellworks reports are for therapy selection.

Q: What are the benefits of participating as a Physician?

  • There is more patient-specific information available to support therapy selection than ever before. Cellworks does the analysis and provides the following for physicians:
    • Ability to select the most efficacious drug or drug combination for a patient based on a biosimulation of how a patient’s tumor profile responds to standard care drugs and novel combination therapies.
    • Knowledge of how an individual patient will respond to all standard care drugs and novel combinations therapies prior to treatment. The biosimulation analyzes mutational interactions of 4,000+ networked genes to predict and rank phenotype responses to millions of drug combinations
    • Helps patients avoid the unnecessary side effects of therapies that will not produce a response in their specific tumor.
    • Improvement of overall survival rates for patients.

Q: What are the benefits of participating as a patient?

  • Cellworks removes the black box from the analysis for treatment selection by providing rationales that explain how your unique molecular pathways will respond to treatments.
  • Knowledge of how an individual patient will respond to all standard care drugs and novel combinations therapies prior to treatment. The biosimulation analyzes mutational interactions of 4000+ networked genes to predict and rank phenotype responses to millions of drug combinations
  • Avoid the unnecessary side effects of therapies that will not produce a response from your specific tumor.
  • Improvement of overall survival rates for patients.

Q: What are the benefits of participating as an Institution?

  • Helping patients avoid the unnecessary side effects of therapies that will not produce a response in their specific tumor.
  • Improvement of overall survival rates for patients.
  • Ability to select the most efficacious drug or drug combination for a patient based on a biosimulation of how a patient’s tumor profile responds to standard care drugs and novel combination therapies.
  • Knowledge of how an individual patient will respond to all standard care drugs and novel combinations therapies prior to treatment. The biosimulation analyzes mutational interactions of 4000+ networked genes to predict and rank phenotype responses to millions of drug combinations

Q: What are the risks of participation?

The risk is the same as for any treatment provided to a patient with cancer –

  • that the treatment will not be effective in treating the patient’s cancer.
  • side effects of the treatment
  • Cellworks also does not provide information regarding drug toxicity. This determination will need to be made by the treating physician.

Q: What indications are included?

There are over 150 indications included in the myCare-101 trial, below is a partial list. A full list is available here

  • Bladder
  • Bone
  • Brain
  • Breast
  • Esophagus and Stomach
  • Extragonadal Germinal Cell Tumors
  • Genital Tract, Lower - Female
  • Genital Tract, Lower - Male
  • Head and Neck
  • Kidney
  • Large Intestine and Anus
  • Leukemia
  • Liver and Bile Duct
  • Lung and Bronchus
  • Lymphoma
  • Lymphoma - Hodgkin
  • Lymphoma - Non-Hodgkin
  • Melanoma
  • Mesothelioma
  • Myelodysplastic Syndrome
  • Myeloma
  • Myeloproliferative Disease
  • Ovary and Fallopian Tube
  • Pancreas
  • Prostate
  • Skin
  • Small Intestine
  • Soft Tissue
  • Testes
  • Thymus
  • Urothelial Carcinoma
  • Uterus
  • Cancer of Unknown Primary

Q: Can a patient participate if their indication is not on the list?

Only patients who have a cancer type included on the Cellworks indication list are eligible.

Q: Who pays for the drugs during this trial?

During this trial your drugs should be obtained by the usual methods for acquiring treatments. This can include: private insurance, other clinical trials and Medicare Part D.

Requirements

Q: What is required in order to participate?

There are 5 requirements:

  1. Physicians must enroll a current patient and the next three (3) eligible patients.
  2. Patients must have a cancer type included on the Cellworks indication list.
  3. All patients must have an NGS report that is dated within the past 90 days from a Cellworks approved vendor. (Approved vendors: Foundation Medicine, Caris, Tempus, MSK-IMPACT, Ashion GEM ExTra, Illumina TruSight Oncology 500)
  4. Additional laboratory testing is required for the following indications:
    • Hematological Indication
      • Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered
    • Acute Myeloid Leukemia (AML)
      • FLT3-itd testing has been ordered
    • Brain Cancer (e.g., glioblastoma)
      • Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered
      • MGMT Methylation test has been ordered
  5. Patients are eligible at any stage of disease as long as they have a prognosis of 6 months or more.

Q: Which NGS reports are accepted as part of the trial?

Patients can have an NGS report from any of the following vendors.

  • Ashion GEM ExTra
  • Caris
  • Foundation Medicine
    • CDx and Heme
  • Illumina TruSight Oncology 500 (TSO-500)
  • MSK-IMPACT
  • Tempus
    • xE and xT

Q: If a patient has an NGS report from a vendor that is not on the pre-approved list, is it possible to get it approved?

Yes, please submit your request to support@cellworks.zendesk.com

Patient Participation

Q: Can my patient participate if they were treated after receiving their NGS report?

Yes, your patient can participate if the most recent NGS report is provided, though we recommend an NGS report being run after the most recent treatment.

Q: Can my patient be enrolled in other clinical trials alongside 101?

Yes, patients can be enrolled in other clinical trials while participating in myCare-101.

Q: How many patients can be enrolled?

The minimum requirement is to enroll your current patient and the next three (3) eligible patients. There is no maximum number of patients that a physician can enroll.

Q: Can patients outside the U.S. participate?

No, the trial is only open to patients within the U.S. at this time, but the trial may expand to patients outside the U.S. at a later time.

Q: Can children participate in the trial?

No, the trial is not open to patients under 18 at this time, but children may be able to participate in the future.

Q: Can a patient opt out after joining the trial?

Yes. Participation in the trial does not mean that the Cellworks recommendation needs to be followed. It is the decision of the treating oncologist and the patient to follow or not follow the treatment recommended in a Cellworks report.

Reports

Q: What is the difference between the Singula and Ventura reports?

Singula reports predict an individual patent’s response to standard care therapies. For refractory patients, Ventura reports predict and rank the patient’s response to combinations of FDA-approved drugs, including off-label and non-oncology drugs.

Q: Can I request both Singula and Ventura reports for a patient?

Yes you can. You will place a single order but select and receive two separate reports.

Q: How do I order a Cellworks report?

First create an account, then login to the portal and place an order.

To create an account:

Q: How much time does it take to receive Cellworks reports once ordered?

Reports are available within the Cellworks Portal within 3-5 days from the time the reports are ordered.

Q: How do I receive Cellworks reports?

Once you have created an account, you will have access to the Cellworks Portal on www.cellworks.life, by clicking Portal and logging in. You can download your patient reports from this portal.

Q: Am I required to use the therapy(s) recommended for my patient in the Cellworks report?

No, you are not required to follow the treatment recommendation in a Cellworks Report if you decide not to. The Cellworks reports are intended for you and your patient to use as a resource during your therapy decision-making process.

Surveys

Q: Who is expected to complete the Cellworks surveys?

Physicians and participating patients will receive surveys, although the patient surveys are optional.

Q: What questions are in the survey?

The survey questions for physicians and patients can be found here

Q: How will the surveys be conducted?

Survey links for both physicians and patients will be sent to the physician. Physicians are requested to forward the patient survey links to their patients.

Q: What type of questions will the survey include?

The physician and patient are asked 8-10 questions each about the usefulness of the Cellworks reports and the value of the information in making a treatment decision. Answers are provided in a scale format from Strongly Agree to Strongly Disagree.

Q: How many surveys do I need to complete?

For physicians, one survey is required per patient.

Q: How many surveys does my patient need to complete?

Patients receive one survey each, but these are optional.

Q: How long will I have to complete the survey?

We request that all physician and patient surveys be complete within 10 weeks after receipt. We will send reminder emails to the physician once every week for four weeks after sending the survey.

Q: Are the survey responses required or optional?

Physicians are required to complete one survey per patient under the terms and conditions of the myCare-101 trial. Patient surveys are optional.

Trial Length and Locations

Q: When did the myCare-101 trial begin?

Enrollment began in 2020.

Q: Where is myCare-101 taking place?

This is a multi-site trial with unlimited locations across the U.S.

Q: How will the trial last?

The trial will continue until 1,500 patients have been enrolled. We expect final results to be available in 2023.

Q: How long am I expected to participate in the trial?

Physicians are expected to participate until you have received Cellworks reports and completed surveys for your current patient and your next 3 eligible patients. No outcome follow-up is required.

ENROLLMENT NOTIFICATION

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