Status:
NOT_YET_RECRUITING
A Phase III Study of Ivonescimab + Chemo With/Without AK117 vs Chemo in Metastatic Pancreatic Cancer
Lead Sponsor:
Akeso
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patien...
Eligibility Criteria
Inclusion
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
- No prior systemic anti-cancer treatment for metastatic PDAC.
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Adequate organ function.
Exclusion
- Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
- Presence of active central nerve system (CNS) metastases.
- Known germline BRCA1/2 or PALB2 mutations.
- Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- History of other malignancies within the past 5 years.
- History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
- Previous anti-angiogenic therapy and immunotherapy.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Pregnant or breastfeeding women.
- Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2028
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT06953999
Start Date
May 14 2025
End Date
May 14 2028
Last Update
May 1 2025
Active Locations (2)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 20032
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022