Trials / Completed
CompletedNCT04705818
Combining Epigenetic And Immune Therapy to Beat Cancer.
Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Institut Bergonié · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.
Detailed 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 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
Conditions
- Advanced Solid Tumor
- Advanced Colorectal Carcinoma
- Advanced Soft-tissue Sarcoma
- Advanced Pancreatic Adenocarcinoma
- Adult Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Durvalumab will be administered by intraveinous infusion (1120 mg) on day 1, every 3 weeks. Treatment by durvalumab will start on Day 22 (i.e., day 1 of cycle 2) |
| DRUG | Tazemetostat | Tazemetostat will be administered per-os, twice daily (800 mg x 2), continuously. Treatment by tazemetostat will start on day 1 (of cycle1). |
Timeline
- Start date
- 2021-07-23
- Primary completion
- 2024-01-07
- Completion
- 2025-07-17
- First posted
- 2021-01-12
- Last updated
- 2026-03-06
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04705818. Inclusion in this directory is not an endorsement.