Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: II/III (Cancer Control)
Principal Investigator: Leuva, Harshraj
Contact Information:
Micki Bethea, BS
+1 402-559-8011
mbethea@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05987241?term=NCT05987241%20&rank=1#participation-criteria
Summary
2.1 Co-primary objectives
2.1.1 To compare the ctDNA clearance proportion [i.e., ctDNA (+); ctDNA (-)] at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion)
2.1.2 To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion)
2.1.3 To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)
2.2 Secondary objectives
2.2.1 To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.
2.2.2 To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.
2.2.3 To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).
2.2.4 To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.
2.2.5 To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.
2.2.6 To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.
2.2.7 To determine the safety of adjuvant nivolumab plus relatlimab.
2.3 Exploratory objectives
2.3.1 To explore the kinetics of quantitative ctDNA levels (mean number of tumor molecules observed per mL of plasma or MTM/ml) over time and the association between ctDNA kinetics and time-to-event outcomes
2.3.2 To estimate the costs and value of care in patients with a ctDNA(+) assay post-cystectomy treated with adjuvant nivolumab versus nivolumab + relatlimab.
2.3.3 To estimate the costs and value of care in patients with a ctDNA(-) assay post-cystectomy treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).
2.4 Quality of life objectives
2.4.1 Within each cohort, to compare quality-adjusted survival among randomized arms using EQ-5D-5L.
2.4.2 Within Cohort B, to compare overall QOL as measured by the EORTC QLQ-C30 between baseline and 42 months (calculated as the area under the curve) among randomized arms.
2.4.3 Within each cohort, to compare overall QOL as measured by the EORTC QLQ-C30 at each time point among randomized arms.
2.4.4 Within each cohort, to compare bladder cancer-specific QOL as measured by the EORTC QLQ-BLM30 at each time point among randomized arms.
2.4.5 Within each cohort, to compare patient-reported fatigue as measured by PROMIS-Fatigue at each time point among randomized arms.