Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase II, Prospective, Multicenter Study of Cadonilimab in Combination With FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839470
• Other study ID #: SYLT-026
• Status: Recruiting
• Phase: Phase 2
• Start date: November 19, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: Fujian Cancer Hospital
• Contact: Rongbo Lin
• Phone: 0591-83660063
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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）

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• cadonilimab
Cadonilimab (6mg/kg, iv, Q2W, Day1)
• irinotecan
irinotecan* 165 mg/m² iv continue for 1.5 hours, D1
• Oxaliplatin
oxaliplatin 85 mg/m² iv continue for 2 hours,
• leucovorin or levoleucovorin
leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
• 5-FU
5-FU 2400 mg/m² cont. inf. 46h

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	RECIST 1.1	Up to two years
Secondary	Progression free survival (PFS)	RECIST 1.1	Up to two years