Colorectal Cancer
Conditions
Brief 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）
Interventions
DRUGcadonilimab
Cadonilimab (6mg/kg, iv, Q2W, Day1)
DRUGirinotecan
irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1
DRUGOxaliplatin
oxaliplatin 85 mg/m² iv continue for 2 hours,
leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
DRUG5-FU
5-FU 2400 mg/m² cont. inf. 46h
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to two years | RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to two years | RECIST 1.1 |
Countries
China
Contacts
Primary ContactRongbo Lin
Outcome results
None listed