Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Solid tumors

1 Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed (≥4 weeks after initial documentation of response) objective response (per RECIST v1.1)

1 IRC-assessed duration of response (DOR), clinical benefit rate (CBR), and progression-free survival (PFS) per RECIST v1.1, 2 Investigator (INV)-assessed ORR, DOR, CBR, and PFS per RECIST v1.1, 3 IRC- and INV-assessed time to CNS progression per RECIST v1.1, 4 Overall survival (OS), 5 Cohorts A, B, C, D, I, J, and K: IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO, 6 Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO, 7 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: IRC-assessed ORR, DOR, CBR, and PFS per International Neuroblastoma Response Criteria (INRC), 8 Cohorts A, B, C, D, E, H, I, J, K, L, M, and N: INV-assessed ORR, DOR, CBR, and PFS per INRC, 9 Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1, 10. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1, 11. Descriptive endpoint of time to confirmed deterioration, change from baseline, proportion of patients with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, 12. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC IL71, 13. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events, 14. Cohort K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib with Acceptability Survey scores on Day 1 of Cycle 1

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Belgium, Denmark, France, Germany, Italy, Poland, Portugal, Spain