Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05426005
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2022-06-15
Brief Title:
Cadonilimab for PD-1PD-L1 Blockade-refractory MSI-HdMMR Advanced Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Cadonilimab Bispecific Anti-PD-1CTLA-4 Antibody for PD-1PD-L1 Blockade-refractory Microsatellite Instability-high MSI-H or Mismatch Repair-deficient dMMR Advanced Colorectal Cancer a Single Group Multicenter Phase 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
KEYNOTE-177 is currently the only randomized controlled phase III clinical trial evaluating the efficacy and safety of pembrolizumab versus standard chemotherapy combined with targeted first-line therapy for dMMRMSI-H metastatic colorectal cancer The study was conducted at 192 centers in 23 countries and enrolled a total of 307 subjects The results of the study showed that the median PFS of pembrolizumab was 165 months which was double the 82 months in the chemotherapy group HR 060 95 CI 045-080 P 00002 In addition the ORR was 451 in the pembrolizumab group and 331 in the chemotherapy group and a higher percentage of patients achieving a complete remission CR with pembrolizumab than in the chemotherapy group 131 vs 39 The US FDA approved pembrolizumab in June 2020 for the first-line treatment of MSI-HdMMR metastatic colorectal cancer
The results of the KEYNOTE-177 study showed that 29 of patients with dMMRMSI-H metastatic colorectal cancer experienced direct disease progression PD after first-line pembrolizumab monotherapy This may suggest that some dMMRMSI-H patients have primary resistance to anti-PD-1 monotherapy In the first-line treatment cohort of the CheckMate 142 study using nivolumab combined with ipilimumab the proportion of patients with direct PD was 13 suggesting that the combination of PD-1 inhibitors and anti-CTLA-4 mAb may have help overcome this primary resistance In addition in the second-line and above cohort of the CheckMate142 study 12 of patients receiving nivolumab in combination with ipilimumab experienced PD directly compared with 26 of patients receiving nivolumab alone
A study published on The Lancet Oncolog on the efficacy and safety of ipilimumab monotherapy and ipilimumab combined with anti-PD-1 monoclonal antibody in patients with anti-PD-1 monoclonal antibody-resistant melanoma Retrospective study The study included 355 patients with unresectable metastatic stage III or IV melanoma who received ipilimumab monotherapy after failure of anti-PD-L1 monoclonal antibody n162 or Ipilimumab combined with anti-PD-1 therapy n193 The ORR was 31 in the combination arm significantly higher than the 13 in the ipilimumab monotherapy arm In addition the median OS and PFS of the combination therapy group were 204 months and 30 months respectively which were also significantly higher than those of the single-agent group of 88 months and 26 months
The aim of this study was to evaluate the objective response rate ORR of Cadonilimab a bispecific anti-PD-1CTLA-4 antibody for PD-1PD-L1 blockade-refractory microsatellite instability-high MSI-H or mismatch repair-deficient dMMR advanced colorectal cancer
The results of the KEYNOTE-177 study showed that 29 of patients with dMMRMSI-H metastatic colorectal cancer experienced direct disease progression PD after first-line pembrolizumab monotherapy This may suggest that some dMMRMSI-H patients have primary resistance to anti-PD-1 monotherapy In the first-line treatment cohort of the CheckMate 142 study using nivolumab combined with ipilimumab the proportion of patients with direct PD was 13 suggesting that the combination of PD-1 inhibitors and anti-CTLA-4 mAb may have help overcome this primary resistance In addition in the second-line and above cohort of the CheckMate142 study 12 of patients receiving nivolumab in combination with ipilimumab experienced PD directly compared with 26 of patients receiving nivolumab alone
A study published on The Lancet Oncolog on the efficacy and safety of ipilimumab monotherapy and ipilimumab combined with anti-PD-1 monoclonal antibody in patients with anti-PD-1 monoclonal antibody-resistant melanoma Retrospective study The study included 355 patients with unresectable metastatic stage III or IV melanoma who received ipilimumab monotherapy after failure of anti-PD-L1 monoclonal antibody n162 or Ipilimumab combined with anti-PD-1 therapy n193 The ORR was 31 in the combination arm significantly higher than the 13 in the ipilimumab monotherapy arm In addition the median OS and PFS of the combination therapy group were 204 months and 30 months respectively which were also significantly higher than those of the single-agent group of 88 months and 26 months
The aim of this study was to evaluate the objective response rate ORR of Cadonilimab a bispecific anti-PD-1CTLA-4 antibody for PD-1PD-L1 blockade-refractory microsatellite instability-high MSI-H or mismatch repair-deficient dMMR advanced colorectal cancer
Detailed Description:
None
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