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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine

    Drug

    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

  • Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

    Drug

    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

  • Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

    Drug

    Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Treatment groups

999 Participants
are divided into 3 treatment groups
Group A: Ivonescimab + AK117 + Albumin-bound Paclitaxel + GemcitabineExperimental treatment 1 intervention
Group B: Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + GemcitabineExperimental treatment 1 intervention
Group C: Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + GemcitabineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall response (OS)

Overall Survival (OS) is defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Progression Free Survival (PFS) assessed by investigator per RECIST v1.1

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.

Time frame
Up to approximately 2 years
2

Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.

Time frame
Up to approximately 2 years
3

Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

Disease control rate (DCR) assessed according to RECIST v1.1.

Time frame
Up to approximately 2 years
4

Duration of response (DoR) assessed by the investigator per RECIST v1.1

Duration of response (DoR) assessed according to RECIST v1.1.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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