Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428487
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-03-05
Brief Title:
Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer
Sponsor:
Blokhins Russian Cancer Research Center
Organization:
Blokhins Russian Cancer Research Center
Study Overview
Official Title:
Phase IIOpen-label Non-randomized Study of Neoadjuvant Prolgolimab Monotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability MSIMismatch Repair dMMR Deficiency
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
In this phase II study patients with stage II-III MSIdMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy prolgolimab The duration of treatment is 6 months 12 cycles
Detailed Description:
In this open-label phase II non-randomized study the investigators will enroll 30 patients with stage II-III MSIdMMR colorectal cancer to receive anti-PD1 inhibitor prolgolimab
Patients will be treated with 12 cycles 6 months of prolgolimab 1 mgkg every 2 weeks until surgery
Patients will be treated with 12 cycles 6 months of prolgolimab 1 mgkg every 2 weeks until surgery
Study Oversight
Has Oversight DMC:
None
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?:
None