A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall response (OS)
Time frame: Up to approximately 2 years
Secondary Endpoints
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign a written informed consent form. 2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of ≥ 3 months. 5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC). 6. No prior systemic anti-cancer treatment for metastatic PDAC. 7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 8. Adequate organ function. Exclusion Criteria: 1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types. 2. Presence of active central nerve system (CNS) metastases. 3. Known germline BRCA1/2 or PALB2 mutations. 4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage. 5. History of other malignancies within the past 5 years. 6. History of significant b…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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