Page History

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• On Tier 1, all participants must be treatment naïve. There are even in protocols for Tier 1, patients can have taken some therapy as long as it’s a minimal dose.

In the A3 schema there is an indication that there should be a max of 6 pts enrolled to cohort 4 for a given histology.  How will this be handled in the screening trial and in terms of managing/capping enrollment to cohort 4? 

• This will be handled in MATCHbox. No assignments will be generated for Histology once maximum is reached.

What happens/what is the process when the site leaves the DLAP Scenario ID blank? What happens/what is the process when there’s a blank DLAP Scenario ID under Physician’s choice?

• The site user may not have a scenario ID so they don’t have to populate it. Field is required on the EC form but may be left blank by the site in the event that the data has not yet been entered and confirmed in DLAP.​ There is no correlation between Physicians choice or DLAP.

Is it correct that two Off Treatment forms aren’t needed for a crossover?

• The Off Treatment from does not need to be completed for a Crossover.

The CDE 10948385 is being used to capture the ICD code for Screening and is a text string. Would 6154743 be better as that has a dictionary associated with it that represents the ICD-O-3 topography codes you mentioned?  ​

We are asking so we don’t collect a different data element on the treatment form then what is being collected on the screening form and this would allow Alliance to monitor the rates as well and if we need to do some collapsing of a set of codes to a broader class of “histology/type of cancer” we would be able to evaluate that as we go.

• The fields on the screening protocol are integrated with the disease service. We will consider this option at a future timepoint, but you will have access in MATCHbox to view this data in real-time and export that data.

ComboMATCH Questions

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• NCI still currently working on re-registration requirements.

We are in the process of writing specifications for folder rollout for the ComboMATCH Screening protocol in Rave.  The assumption is that we need to build multiple Steps into Rave.  I have reviewed all the materials, including the test plans and instructions for generating OPEN Checklists, and it appears that there is no plan to have the ability to enter Step 2 registrations in the Screening Study at Go Live.  Is this correct?

• Yes, this is correct. Step 2 is only for re-registration.

We are finishing out study builds for our ComboMATCH treatment trial (EAY191-S3) and our MyeloMATCH treatment trial (MM1YA-S01) and I would like to confirm the correct arm names and/or Treatment Assignment Codes.  Can you please provide the correct names and codes for these two trials?

• MATCHBox the IDs are below, and they give both stratification and randomization.​ List of codes has been sent.
  • EAY191-S3​
  • MM1YA-01

MeyloMATCH Questions

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• There is no ALS for the Rave EC Template. We are using our normal EC template process. The form is built in caDSR II based on our template and that will provide you the form OID.
• The four fields you will need for that form are:
  • Screening Protocol ID
  • Screening Participant ID
  • Cohort
  • Stratum

What data will be entered in OPEN for a new assignment? How will we get that data into Rave? I assume there’s a template form that we’ll need to build out so the data can be pushed into our Rave instance.

• The PMI Project team will address reassignment questions at a future meeting since reassignment was not part of the Phase 1 release.

How is the step information form going to look for a reassessment vs a new assignment? Will a logline still be added showing that specimens were analyzed but that the decision was that they should stay on their current treatment trial? Is a logline added every time they submit something in OPEN or only in some cases?

• A notification will be sent that a treatment is complete, and the patient is eligible for a new tier assignment.
• ​Every new step in OPEN will result in a log line in Rave. If they get reassigned, they have a log line added.  No additional new log lines based on updates or events, only mapped with STEP.

Will our data management staff have access to the EAY191 Source Documents being uploaded to OPEN?  Typically, we have sites upload Path Reports into Rave, however if EA will have access to the Path Reports uploaded to OPEN we could reduce burden on sites and eliminate duplicate data entry.

• Access can be given in OPEN to view the reports, however you will need to view the report patient by patient.

After the initial paper-based process, it sounds like there will be Precision Medicine Specimen Tracking Forms and the other specimen-related forms submitted via Rave (listed below). Should these forms be part of our study build or will they exist in a different Rave “instance”? ​

• Samples Tracking and Manifest Form
• Local Pathology Group Information Form
• CLIA Laboratory Specimen Submission Form
• MyeloMATCH Generic Specimen Submission Form
• Pathology Group Form

• ​MM Generic Specimen submission form will not be part of the Rave study build; this is a place paper form for the STFM which will be part of the study build in the future.​
• The Below forms are targeted to be added to the PMI Screening Protocol as part of Phase II activities.
  • PMI STMF
  • PMI Pathology Group Form
  • PMI CLIA Submission Form

How is our Randonode supposed to be pushed into OPEN?

• A Randonode setup document was provided to explain how RandoNode is supposed to push into OPEN with the initial release.