Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adult Solid Tumor
  • Advanced Colorectal Carcinoma
  • Advanced Pancreatic Adenocarcinoma
  • Advanced Soft Tissue Sarcoma
  • Advanced Solid Tumor
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 4 independant single-arm, phase II trials, based on 2-stage Simon's optimal design: cohort A: pancreatic cancer cohort B: not MSI-H or MMR-deficient colorectal cancer cohort C: metastatic solid tumor with positive interferon gamma signature and/or prensece of tertiary lymphoid structure cohort D: soft-tissue sarcoma Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

4 independant, multicenter, prospective, signle-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of durvalumab when prescribed with tazemetostat, separately, in distinct cohorts of solid tumors: cohort A: patients with pancreatic canc...

4 independant, multicenter, prospective, signle-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of durvalumab when prescribed with tazemetostat, separately, in distinct cohorts of solid tumors: cohort A: patients with pancreatic cancer cohort B: patients with colorectal cancer not MSI-H or MMR-deficient cohort C: patients with metastatic solid tumors with positive interferon gamma signature and/or tertiary lymphoid structure positive cohort D: patients with soft-tissue sarcoma

Tracking Information

NCT #
NCT04705818
Collaborators
  • AstraZeneca
  • Epizyme, Inc.
Investigators
Not Provided