A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
- Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
- Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
Treatment groups
999 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov