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

NCT05839470 | Unknown Phase 2

• 1 other identifier: SYLT-026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  RECIST 1.1

  Up to two years

Secondary Outcomes (1)

• Progression free survival (PFS)

  Up to two years

Study Arms (1)

Cadonilimab+ FOLFOXIRI+bevacizumab

EXPERIMENTAL

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）

Drug: cadonilimab; Drug: irinotecan; Drug: Oxaliplatin; Drug: leucovorin or levoleucovorin; Drug: 5-FU

Interventions

cadonilimab DRUG

Cadonilimab (6mg/kg, iv, Q2W, Day1)

Cadonilimab+ FOLFOXIRI+bevacizumab

irinotecan DRUG

irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1

Cadonilimab+ FOLFOXIRI+bevacizumab

Oxaliplatin DRUG

oxaliplatin 85 mg/m² iv continue for 2 hours,

Cadonilimab+ FOLFOXIRI+bevacizumab

leucovorin or levoleucovorin DRUG

leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours

Cadonilimab+ FOLFOXIRI+bevacizumab

5-FU DRUG

5-FU 2400 mg/m² cont. inf. 46h

Cadonilimab+ FOLFOXIRI+bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Oxaliplatin; Leucovorin; Levoleucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Rongbo Lin

CONTACT

0591-83660063; rongbo_lin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 3, 2023
• Study Start: November 19, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

CN (1)