RecruitingPhase 2NCT07253896

Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab

Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

40 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of AK104 (a dual checkpoint inhibitor targeting both PD-1 and CTLA-4), chemotherapy, and either cetuximab or bevacizumab as a second-line treatment for patients with metastatic colorectal cancer that is not driven by certain resistance mutations. The goal is to see if adding this immune therapy improves outcomes after first-line treatment has failed. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic colorectal cancer that cannot be surgically removed - Your cancer is MSI-L or MSS type (not microsatellite unstable) - You have only received one prior line of oxaliplatin-based chemotherapy (such as FOLFOX or CAPOX) - You have at least one measurable tumor - Your organ function meets the required thresholds - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your cancer has MSI-H or dMMR status, or a BRAF mutation - You have another cancer in the past 3 years - You have previously received any immunotherapy (such as anti-PD-1 or anti-CTLA-4 drugs) - You have an active autoimmune disease or a history of inflammatory bowel disease - You have HIV, uncontrolled hepatitis B or C, or active tuberculosis - You have had a major surgery or serious infection within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104 and cetuximab or bevacizumab and FOLFIRI

AK104 and cetuximab or bevacizumab and FOLFIRI as the second line


Locations(2)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, China

View Full Details on ClinicalTrials.gov

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NCT07253896


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