ROSETTA GI 204 Eligibility
What is the numerical value, msec for participants with congenital long QT syndrome or a QTc prolongation greater than this value are excluded from the study?
Congenital long QT syndrome or QTc prolongation > 480 msec (the ECG can be repeated at the discretion of the investigator prior to randomization.
If FFPE blocks cannot be provided, a minimum of this many unstained slides must be submitted, and they must be freshly cut within 4 months.
A minimum of 15 unstained slides is required and must be cut sequentially from the same block; submission of 20 unstained slides is strongly recommended to enable important exploratory biomarker work
What is the screening laboratory values below this hemoglobin level that will exclude a participant?
9.0 g/dL
What must Site Imaging personnel responsible for uploading the scans completed prior to site activation and first participant enrollment?
Must complete the training certification prior to site activation and first participant enrollment
Who is the BMS Medical Monitor/Clinical Trial Physician that should be contacted regarding any medical questions?
Ayman Nassar, MB, BS
What is the period of time that Palliative radiotherapy must be completed prior to randomization?
Prior focal palliative radiotherapy must have been completed at least 14 days prior to randomization.
What assay results for tumor tissue must be submitted prior to participant randomization using the Sponsor pre-approved local assays?
Participants must have PD-L1 results by the Sponsor pre-approved local PD-L1 IHC assays or through Sponsor-provided central laboratory testing and available in IRT during the screening period prior to randomization.
What Laboratory assessments must be collected and reviewed within 35 days prior to randomization? However, these 5 lab tests must be collected and reviewed within 14 days before randomization
What are hematology, chemistry, coagulation parameters, thyroid function test and amylase and/or lipase
As long as local laws allow, what vendor can arrange and pay for rideshare, flights, hotels, rail, rental cars, and other study‑related travel through their platform, reducing site coordination burden?
Mural Health administers approved stipends and reimbursements using multiple global payment options (e.g., Venmo, PayPal, Zelle, bank transfer, prepaid cards, checks),
What is the enzyme deficiency name, which must be systematically screened for where locally mandated, is an exclusion criterion?
What is DPD (dihydropyrimidine dehydrogenase)
To be eligible for the study, participants must have an ECOG performance status score of one of these two values?
What are 0 or 1
If a fresh tumor biopsy poses significant risk to the participant, what type of tissue sample may be submitted instead?
•Answer
What is archived tumor tissue
What is the duration of the screening period?
If a participant cannot be randomized within 35 days after screening, they will be regarded as screen-failed, but can be re-enrolled by being re-consented and assigned a new participant number from IRT.
For the study, what must sites check to be sure there is enough inventory and order these items to prevent any delays?
Sites should check lab kit inventory regularly to prevent any delays and check expiration dates of lab kits.
To be eligible, participants with previously treated CNS metastases must be neurologically returned to baseline for at least how many weeks prior to randomization?
Participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization.
What is the period of time prior to randomization that major surgery, open biopsy or significant traumatic injury or anticipation of the need for major surgery during the course of study interventional would exclude a patient?
Within 28 days prior to randomization
How many months can tumor tissue samples, either fresh or archival be submitted prior to date of enrollment?
Tumor tissue requirements:
Fresh or archival (if obtained within 6 months prior to date of enrollment) must be submitted.
What assessments should continue on the protocol-defined imaging schedule regardless of whether dosing is delayed or discontinued?
Tumor Assessments
What is Clario, imaging vendor system preferred method for electronic image submission?
What is SMART Submit
What biomarker must participants have documented as negative status as determined by local guidelines?
Documented HER2-negative cancer, as determined according to local guidelines
What assay results for tumor tissue must be submitted prior to participant randomization using the Sponsor pre-approved local assays?
Participants must have PD-L1 results by the Sponsor pre-approved local PD-L1 IHC assays or through Sponsor-provided central laboratory testing and available in IRT during the screening period prior to randomization.
Regarding Immunophenotyping samples, where/what lab is the whole Blood sample shipped to on the day of collection in ambient conditions?
Immunophenotyping samples are sent to BMS Labs in Lawrenceville:
Immunophenotyping samples are sent to BMS Labs in Lawrenceville:
TO: BMS Biorepository
Bristol Myers Squibb
BMS Biorepository
Attn: Karl Kammerhoff
3551 Lawrenceville Road; Room K1421
Princeton, NJ 08540
Phone: 609-252-5990
Fax: 609-2526509
If MRI is contraindicated, what is the alternative brain imaging method allowed?
CT of the brain with and without contrast
What must never be removed during image de‑identification because it affects timepoint assignment? And, what type of personal information must be removed from all images before submission?
The exam date is never to be removed.
PHI/PII (e.g., patient name, DOB, MRN) must be removed
All participants will enter the follow-up period will undergo 2 safety follow-up visits, Safety follow-up visit 1 and Safety follow-up visit 2. At what times do these 2 Safety follow-up visits occur?
Safety follow-up visit 1 (occurs 30 days [±7 days] after the last dose of study intervention) and safety follow-up visit 2 (occurs 90 days [±7 days] after the last dose of study intervention