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Trial Title:
Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer
NCT ID:
NCT05839470
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Oxaliplatin
Irinotecan
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cadonilimab
Description:
Cadonilimab (6mg/kg, iv, Q2W, Day1)
Arm group label:
Cadonilimab+ FOLFOXIRI+bevacizumab
Intervention type:
Drug
Intervention name:
irinotecan
Description:
irinotecan* 165 mg/m² iv continue for 1.5 hours, D1
Arm group label:
Cadonilimab+ FOLFOXIRI+bevacizumab
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
oxaliplatin 85 mg/m² iv continue for 2 hours,
Arm group label:
Cadonilimab+ FOLFOXIRI+bevacizumab
Intervention type:
Drug
Intervention name:
leucovorin or levoleucovorin
Description:
leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
Arm group label:
Cadonilimab+ FOLFOXIRI+bevacizumab
Intervention type:
Drug
Intervention name:
5-FU
Description:
5-FU 2400 mg/m² cont. inf. 46h
Arm group label:
Cadonilimab+ FOLFOXIRI+bevacizumab
Summary:
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and
CTLA-4, which has the potential to boost immune surveillance in tumors.
This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as
first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal
of this clinical trial is to evaluated the efficacy and safety.
Detailed description:
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and
CTLA-4, which has the potential to boost immune surveillance in tumors.
This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as
first line therapy in patients with metastatic microsatellite stable (MSS) colorectal
cancer. The goal of this clinical trial is to evaluated the efficacy and safety.
Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan* 165 mg/m² iv continue for 1.5 hours, D1;
oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200
mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks
(Q2W) + bevacizumab （5mg/kg，d 1）
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with metastatic pMMR or MSS colorectal adenocarcinoma. Note: MMR or MSI
status will be performed locally by an immunohistochemistry (IHC) or PCR based test
for eligibility.
- Patients who are naïve to systemic treatment in metastatic setting.
- Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included
oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was
completed > 12 months before inclusion.
- Patients with the presence of at least one lesion with measurable disease as per
RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be
considered measurable unless they have clearly progressed since the radiotherapy.
- Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
- Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using
standard of care testing
- Patients with metastatic disease amenable to be resected with potentially curative
surgery
- Patients who have received any systemic treatment for metastatic disease.
- Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2,
anti-CTLA-4 antibodies, other checkpoint inhibitors
- Patients who had received radiation within 14 days prior to the first dose of study
drug
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Rongbo Lin
Phone:
0591-83660063
Email:
rongbo_lin@163.com
Start date:
November 19, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05839470
