NCT06953999RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 999 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 11 Jun 2025
- Primary completion date
- 14 May 2027
- Lead sponsor
- Akeso
- Diseases
- Pancreatic cancer
- NCT number
- NCT06953999
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 999
- From 11 Jun 2025 to the primary completion date, 14 May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
- Previous anti-angiogenic therapy and immunotherapy.
- 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.
Other illness
- Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
- History of other malignancies within the past 5 years.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
Other
- 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.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.