Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer

Launched by SUN YAT-SEN UNIVERSITY · Jun 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Cadonilimab for patients with advanced colorectal cancer that has specific characteristics: it is mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). This means that the cancer does not respond well to some standard treatments, particularly those targeting the PD-1 pathway. The trial aims to see if Cadonilimab can help patients whose cancer has not improved with previous anti-PD-1 therapies.

To be eligible for this trial, participants need to be 18 years or older, have a confirmed diagnosis of colorectal cancer, and have previously tried and not responded well to other PD-1 or PD-L1 treatments. Participants should also have good overall health status, meaning they can do daily activities with minimal assistance. If you decide to join, you will receive the new treatment and be closely monitored for how well it works and any side effects. This trial is important because it may offer a new option for patients who have limited choices due to their cancer's specific characteristics.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing and able to provide written informed consent.
• • 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
• • 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• • 4. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
• • 5. Subjects with stage IV colorectal cancer must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
• • 6. Previous treatment with an anti-PD-1 or PD-L1 monoclonal antibody for advanced or metastatic colorectal cancer has failed. Treatment failure was defined as: disease progression or unacceptable toxicity during treatment or within 6 months after the last treatment.
• • 7. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
• Exclusion Criteria:
• • 1. Previously received anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody.
• • 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
• • 3. Heart failure grade III/IV (NYHA-classification).
• • 4. Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
• • 5. Subjects with known allergy to the study drugs or to any of its excipients.
• • 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
• • 7. Breast- feeding or pregnant women.
• • 8. Lack of effective contraception.