Combining Epigenetic And Immune Therapy to Beat Cancer.
Last updated on July 2021Recruitment
- 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