About this trial
This phase II/III trial studies how well the addition of ivonescimab to standard chemotherapy (gemcitabine and cisplatin) works when compared to usual chemotherapy and immunotherapy (durvalumab or pembrolizumab) in treating patients with biliary tract cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab is a bispecific antibody that is directed against both the programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF) protein. By targeting PD-1, ivonescimab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. By targeting VEGF, ivonescimab may help stop the formation of blood vessels that bring oxygen and nutrients to tumor. Adding ivonescimab to standard chemotherapy may work better than usual chemotherapy and immunotherapy in lowering the chance of advanced biliary tract cancer growing or spreading.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be ≥ 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Patient must have histologically or cytologically confirmed adenocarcinoma of the biliary tract including cholangiocarcinoma (intrahepatic or extrahepatic) or gallbladder carcinoma
Patient must not have a diagnosis of ampullary cancer
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Cisplatin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT
Durvalumab
Biological/VaccineGiven IV
Gemcitabine Hydrochloride
DrugGiven IV
Ivonescimab
Biological/VaccineGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Pembrolizumab
Biological/VaccineGiven IV
Treatment groups
Trial outcomes
Primary outcomes
Overall survival (OS)
Secondary outcomes
Progression-free survival
Will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 as assessed by the investigator.
Objective response rate
Will be defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST v1.1.
Duration of response
Will be measured per RECIST v1.1 as assessed by the investigator.
Disease control rate
Will be defined as the proportion of patients who have achieved CR, PR, or stable disease for ≥ 9 weeks from date of randomization as assessed by the investigator according to RECIST v1.1.
Other outcomes
Estimates of the primary OS outcome treatment effect by sex
Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided.
Estimates of the primary OS outcome treatment effect by race
Estimates of treatment effect and the corresponding 95% CIs will be provided.
Estimates of the primary OS outcome treatment effect by ethnicity
Estimates of treatment effect and the corresponding 95% CIs will be provided.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ECOG-ACRIN Cancer Research Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: