Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer

Summary

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.

Conditions

• Locally Advanced Biliary Tract Adenocarcinoma
• Locally Advanced Extrahepatic Cholangiocarcinoma
• Locally Advanced Intrahepatic Cholangiocarcinoma
• Locally Advanced Unresectable Gallbladder Adenocarcinoma
• Metastatic Biliary Tract Adenocarcinoma
• Metastatic Extrahepatic Cholangiocarcinoma
• Metastatic Gallbladder Adenocarcinoma
• Metastatic Intrahepatic Cholangiocarcinoma
• Stage III Distal Bile Duct Cancer AJCC v8
• Stage III Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IV Distal Bile Duct Cancer AJCC v8
• Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
• Unresectable Biliary Tract Adenocarcinoma
• Unresectable Extrahepatic Cholangiocarcinoma
• Unresectable Intrahepatic Cholangiocarcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Durvalumab

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

BIOLOGICAL

Ivonescimab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Deirdre J Cohen · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-11

Primary Completion

2028-12-31

Completion

2029-12-31

FDA Drug

Yes