Summary datasets from the REVOLUTION clinical trial in metastatic pancreatic ductal adenocarcinoma, as reported in the following manuscript.
O'Reilly EM, Cabanski CR, Lyman JP, Wainberg ZA, Fisher G, Wolff RA, Ko AH, O'Hara MH, Spencer CN, Yu JX, Da Silva DM, Padron LJ, Arnott J, Fairchild J, Moore JS, Peng B, Hoos WA, O'Donnell-Tormey J, Boffo S, Dugan U, Kimmelman AC, Amaravadi RK, Vonderheide RH. Clinical and Translational Results from a Phase 1 Trial of Gemcitabine/Nab-Paclitaxel with Nivolumab/Ipilimumab or Hydroxychloroquine/Ipilimumab in Untreated Metastatic Pancreatic Adenocarcinoma. In Revision.
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- age = Age
- sex = Sex
- race = Race
- ethnicity = Ethnicity
- ecog.screening = ECOG status at Screening (0, 1)
- stage.initial.diagnosis = Stage at Initial Cancer Diagnosis
- stage.enroll = Stage at Enrollment
- primary.canncer.location = Primary Location of Cancer (Pancreas Body, Pancreas Head, Pancreas Tail)
- prior.chemo.flag = "Y" if Patient Received Prior Chemotherapy
- prior.radiation.flag = "Y" if Patient Received Prior Radiation
- prior.surgery.flag = "Y" if Patient Received Prior Cancer-related Surgery
- albumin.baseline = Albumin (g/dL) at Baseline
- CA19.9.baseline = CA19-9 (U/mL) at Baseline
- CA19.9.baseline.cat = CA-19-9 (U/mL) Category at Baseline (<100, 100-1000, >=1000)
- CEA.baseline = CEA (ng/mL) at Baseline
- NLR.baseline = Neutrophil-Lymphocyte Ratio at Baseline
- NLR.baseline.cat = Neutrophil-Lymphocyte Ratio Category at Baseline (<5, >=5)
- liver.lesions.flag = "Y" if Patient had Liver Lesion(s)
- tumor.burden.mm.baseline = Sum of Target Lesions Longest Diameters (mm) at Baseline
- GCSF.ontreatment.use.flag = "Y" if Patient Received GCSF Treatment while Receiving Study Therapy
- 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
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- best.overall.response = Best Overall Response by RECIST version 1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- ae.coded.preferred.term = AE Preferred Term, coded using dictionary MedDRA v26.0
- ae.coded.soc = AE System Organ Class, coded using dictionary MedDRA v26.0
- 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 = "Y" represents the AE was a Serious Adverse Event (SAE)
- ae.related.treatments = Which study treatments the AE was attributed to by the investigator. A blank field indicates the AE was deemed unrelated to all study treatments.
- ae.outcome = AE Outcome
- coding.dictionary = Dictionary that AE Terms were Coded to (MedDRA v26.0)
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- best.overall.response = Best Overall Response by RECIST version 1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- lab.category = Lab Test Type (Chemistry, Hematology, Thyroid Function Testing)
- lab.test = Lab Test Name
- visit = Visit Name when Lab Test was Performed
- study.day = Study Day of Lab Test
- 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
- baseline flag = "Y" indicates the measurement was considered a patient's baseline value
- baseline.value = Baseline Test Value for the Patient
- change.from.baseline = Absolute Change from Baseline
- percent.change.from.baseline = Percentage Change from Baseline
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- best.overall.response = Best Overall Response by RECIST version 1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- study.day.start = Study Day Prior Therapy Started. NA indicates the start date was unknown.
- study.day.end = Study Day Prior Therapy Ended. NA indicates the end date was unknown.
- therapy.verbatim.name = Verbatim (site-reported) Name of Therapy
- therapy.coded.preferred.name = Therapy Preferred Name, coded using dictionary WHODrug
- coding.dictionary = Dictionary that Prior Therapies were Coded to (WHODrug-Global-B3 March 2023)
- therapy.setting = Therapy Setting (Adjuvant, Neoadjuvant, Locally Advanced)
- therapy.best.response = Best Response to the Therapy
Flow Cytometry (X50) - Percent of Parent Population (Cohort A): REV_cohortA_x50_percent-of-parent_public.csv
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A)
- treatment = Treatment Regimen
- timepoint.id = Timepoint of Sample Collection
- cell.population.name = Cell Population
- percent.parent = Abundance Value, measured as the Percentage of the Parent Population
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
Flow Cytometry (X50) - Percent of Parent Population (Cohort B): REV_cohortB_x50_percent-of-parent_public.csv
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (B)
- treatment = Treatment Regimen
- timepoint.id = Timepoint of Sample Collection
- cell.population.name = Cell Population
- percent.parent = Abundance Value, measured as the Percentage of the Parent Population
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A)
- treatment = Treatment Regimen
- timepoint.id = Timepoint of Sample Collection
- protein.name = Name of Protein
- npx = Protein Expression, measured as NPX Units
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (B)
- treatment = Treatment Regimen
- timepoint.id = Timepoint of Sample Collection
- protein.name = Name of Protein
- npx = Protein Expression, measured as NPX Units
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- timepoint.id = Timepoint of sample collection (BL [baseline] or Archival)
- msi = MSI Classification
- tmb = Tumor Mutational Burden, measured as Number of Mutations per Megabase
- manuscript.id = Deidentified Subject ID reported in the manuscript
- cohort = Treatment Cohort (A, B)
- treatment = Treatment Regimen
- best.overall.response = Best Overall Response per RECIST v1.1
- os.1yr.status = Overall Survival status at 1 year (Alive, Dead, Unknown [censored])
- chromosome = Chromosome of mutation
- position = Sequence position of mutation
- gene.symbol = Gene symbol where mutation occurs
- variant.type = type of mutation
- variant.effect = Effect of mutation
- variant.effect.impact = predicted effect of mutation
- functional.class = functional class of mutation