Status:
RECRUITING
Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Cancer Stage IV
Mismatch Repair-deficient (dMMR)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
KEYNOTE-177 is currently the only randomized controlled phase III clinical trial evaluating the efficacy and safety of pembrolizumab versus standard chemotherapy combined with targeted first-line ther...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
- 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.
- 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.
- Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
Exclusion
- Previously received anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
- Heart failure grade III/IV (NYHA-classification).
- Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Breast- feeding or pregnant women.
- Lack of effective contraception.
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05426005
Start Date
February 7 2023
End Date
July 1 2027
Last Update
March 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655