amadeus-crpc-trial-data

Summary datasets from the AMADEUS prostate expansion cohort (NCT03651271), as reported in the following manuscript.

Tsimberidou AM, Cabanski CR, Drakaki A, Khalil DN, Siddiqui BA, Basu S, Okrah K, Da Silva DM, Gautam S, Alayli FA, Schachter M, Fairchild J, Foo WC, Boffo S, Arnott J, Dugan U, Subudhi SK, Sharma P. Immune Biomarkers of Response and Resistance to Ipilimumab and Nivolumab in Metastatic Castration-Resistant Prostate Cancer. Submitted.

Data from one patient who received nivolumab monotherapy that was not discussed in the manuscript is also included. Translational datasets may include timepoints not presented in the manuscript.

DATA DICTIONARY

clinical-data

Subject-Level Data: AMADEUS_CRPC_subject.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• age = Age
• sex = Sex
• race = Race
• ethnicity = Ethnicity
• tumor.type = Tumor Type
• prior.lines.of.therapy = Number of Prior Lines of Systemic Anti-cancer Therapy
• ecog.screening = ECOG status at Screening (0, 1)
• stage.at.diagnosis = Stage at Initial Cancer Diagnosis
• stage.at.enrollment = Stage at Enrollment
• treatment.duration.months = Time from First Dose to Last Dose of Study Drug in Months
• psa.baseline = Prostate Specific Antigen (PSA) (ng/mL) at Baseline
• psa.min.ontrt = Minimun PSA value (ng/mL) Across All Post-Baseline Timepoints
• cd8.percent.baseline = Percentage of tumoral CD8 from IHC at Baseline
• cd8.percent.max.ontrt = Maximum Percentage of tumoral CD8 Across All Post-Baseline Timepoints
• best.overall.response = Best Overall Response by RECIST version 1.1
• pfs.months = Progression free survival (months)
• pfs.event.flag = "0" represents a censored value, "1" represents a PFS event was observed
• os.months = Overall Survival (months)
• os.event.flag = "0" represents a censored value, "1" represents an OS event (death) was observed
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• biopsy.location.baseline = Location of Baseline Tumor Biopsy
• biopsy.location.ontrt = Location of On-Treatment Tumor Biopsy

Adverse Events: AMADEUS_CRPC_ae.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• ae.coded.preferred.term = AE Preferred Term
• ae.coded.soc = AE System Organ Class
• study.day.start = Study Day of AE Start
• study.day.end = Study Day of AE End. "NA" represents an event that was ongoing at time of study discontinuation.
• ae.severity = AE Severity Grade
• ae.serious = "Yes" represents the AE was a Serious Adverse Event (SAE)
• ae.relationship.to.nivolumab = Investigator-Assessed Relationship of AE to Nivolumab
• ae.relationship.to.ipilimumab = Investigator-Assessed Relationship of AE to Ipilimumab
• ae.outcome = AE Outcome
• coding.dictionary = Dictionary that AE Terms were Coded to

Clinical Labs: AMADEUS_CRPC_labs.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• visit = Visit Name when Lab Test was Performed
• study.day = Study Day of Lab Test
• lab.category = Lab Test Type (Chemistry, Hematology, Thyroid Function Testing, Urinalysis)
• lab.test = Lab Test Name
• lab.value = Value of Lab Test
• lab.units = Units of Lab Test
• lower.limit.normal = Lower Limit of Normal Range
• upper.limit.normal = Upper Limit of Normal Range

Prostate Specific Antigen (PSA): AMADEUS_CRPC_PSA.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• study.day = Study Day of Assessment
• lab.test = Lab Test Name (PSA)
• lab.value = Value of Lab Test
• lab.units = Units of Lab Test
• baseline.value = PSA Value at Baseline
• change.from.baseline = Absolute Change in PSA from Baseline (lab.value - baseline.value)
• percent.change.from.baseline = Percent Change in PSA from Baseline

translational-data

Mass Cytometry (CyTOF) - Percent of Parent Population: AMADEUS_CRPC_cytof_percent-of-parent.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• best.overall.response = Best Overall Response per RECIST v1.1
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• timepoint.id = Timepoint of Sample Collection
• cell.population.name = Cell Population
• percent.of.parent = Abundance Value, measured as the Percentage of the Parent Population

Olink Serum Proteomics: AMADEUS_CRPC_olink.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• best.overall.response = Best Overall Response per RECIST v1.1
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• protein.name = Name of Protein
• npx = Protein Expression, measured as NPX Units

RNA Sequencing - Baseline: AMADEUS_CRPC_rnaseq_counts_baseline.csv

• sample.id = Combination of subject.id and timepoint.id
• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• timepoint.id = Timepoint of Sample Collection (BL = baseline)
• arm = Treatment Arm
• treatment = Treatment Regimen
• best.overall.response = Best Overall Response per RECIST v1.1
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• gene.hgnc.symbol = Gene Name
• count = Raw Counts

RNA Sequencing - On-Treatment: AMADEUS_CRPC_rnaseq_counts_ontreatment.csv

• sample.id = Combination of subject.id and timepoint.id
• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• timepoint.id = Timepoint of Sample Collection (OT = on-treatment)
• arm = Treatment Arm
• treatment = Treatment Regimen
• best.overall.response = Best Overall Response per RECIST v1.1
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• gene.hgnc.symbol = Gene Name
• count = Raw Counts

Whole Exome Sequencing - MSI, Tumor Mutational Burden, and select Alterations at Baseline: AMADEUS_CRPC_wes.csv

• subject.id = Subject ID
• manuscript.id = ID reported in the manuscript
• arm = Treatment Arm
• treatment = Treatment Regimen
• best.overall.response = Best Overall Response per RECIST v1.1
• disease.control.flag = Indicates whether a Patient Achieved Disease Control (Partial Response or Stable Disease > 6 Months): Yes/No
• msi = MSI Classification
• tmb = Tumor Mutational Burden, measured as Number of Mutations per Megabase
• tmb.categories = TMB Category (TMB.high / TMB.low), using a cutoff of 10 mut/Mb
• TP53 = "TP53 mut" for patients with a TP53 mutation
• PTEN = "P10 del" for patients with a P10 deletion
• RB1 = "RB1 del" for patients with a RB1 deletion
• HRD = "HRD+" for patients with a mutation in an HRD gene (defined in manuscript supplementary table)
• DDR = "DDR+" for patients with a mutation in an DDR gene (defined in manuscript supplementary table)