Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04705818
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2021-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combining Epigenetic And Immune Therapy to Beat Cancer.
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAIRE
Brief 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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-003303-35 | EUDRACT_NUMBER | None | View |