A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
- 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.
- Short title
- A Phase III Study of Ivonescimab + Chemo With/Without AK117 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-05-14
- First posted
- 2025-05-01
- Registry last updated
- 2026-03-04
- Primary completion date
- 2027-05-14
- Start date
- 2025-06-11
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Akeso
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06953999
- ClinicalTrials.gov ID
- NCT06953999
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Overall response (OS)
Timeframe: Up to approximately 2 years
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Timeframe: Up to approximately 2 years
PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Timeframe: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Timeframe: Up to approximately 2 years
Disease control rate (DCR) assessed according to RECIST v1.1.
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Timeframe: Up to approximately 2 years
Duration of response (DoR) assessed according to RECIST v1.1.
Time to response (TTR) assessed by the investigator per RECIST v1.1
Timeframe: Up to approximately 2 years
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Adverse Events (AEs)
Timeframe: Up to approximately 2 years
An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment.
Cmax and Cmin
Timeframe: Up to approximately 2 years
AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Anti-drug antibodies (ADA)
Timeframe: Up to approximately 2 years
Number of subjects with detectable anti-drug antibodies (ADA).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting
- Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Malignant pancreatic neoplasm Primary condition
- Pancreatic neoplasm