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This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 | Experimental | Participants will receive AK104 before and after surgery |
|
| Physician's choice of chemotherapy | Active Comparator | Participants will receive physician's choice of chemotherapy after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab (AK104) | Drug | Anti-PD-1/CTLA-4 tetrameric bispecific antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) rate as assessed by investigator | Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator | 1 month after surgery |
| Event Free Survival (EFS) | Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death from any cause | Up to approximately 5 years |
| R0 resection rate | Proportion of R0 resection in participant receiving tumor surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xufang Yu, MD | Contact | 021-60472800 | xufang.yu@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| Oxaliplatin |
| Drug |
Intravenous |
|
| Capecitabine | Drug | Oral |
|
| 5- Fluorouracil | Drug | Intravenous |
|
| Calcium Folinate | Drug | Intravenous |
|
| Up to approximately 2 years |
| Adverse event | Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory findings | Up to approximately 5 years |
| Pharmacokinetics (PK) | Serum concentrations of AK104 (Cadonilimab) at different point of time after AK104 administration | Up to approximately 2 years |
| Anti-Drug Antibodies(ADAs) | Number and proportion of participants with detectable ADA. | Up to approximately 2 years |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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