Clinical trial NCT06953999: A Phase III Study of Ivonescimab + Chemo With/Without AK117 vs Chemo in Metastatic Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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 bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
7. Previous anti-angiogenic therapy and immunotherapy.
8. Active autoimmune disease requiring systemic treatment within the past 2 years.
9. Pregnant or breastfeeding women.
10. 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.

Primary outcomes:
measure: Overall response (OS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR) assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: Time to response (TTR) assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Cmax and Cmin
timeFrame: Up to approximately 2 years
measure: Anti-drug antibodies (ADA)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: