A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Pancreatic Cancer
In brief
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 patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.
Key facts
- Study ID
- NCT06953999
- Run by
- Akeso
- People needed
- 999
- Starts
- 2025-06-11
- Expected to finish
- 2028-05-14
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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