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

Sponsor
ECOG-ACRIN Cancer Research Group
Study ID
NCT07765433
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Durvalumab — BIOLOGICAL
    Given IV
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Ivonescimab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Jan 11, 2027
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (gemcitabine, cisplatin, durvalumab, pembrolizumab)
    Patients receive gemcitabine IV over 30-60 minutes and cisplatin IV on days 1 and 8 of each cycle, as well as durvalumab IV over 60 minutes or pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After cycle 8, patients receive durvalumab IV over 60 minutes or pembrolizumab IV over 30 minutes on day 1 of each cycle with or without gemcitabine IV over 30-60 minutes on days 1 and 8 of each cycle per the investigator's discretion. Cycles repeat every 21 days for up to 2 years from study treatment initiation in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood and urine samples throughout the study.
  • Experimental: Arm B (gemcitabine, cisplatin, ivonescimab)
    Patients receive gemcitabine IV over 30-60 minutes and cisplatin IV on days 1 and 8 of each cycle, as well as ivonescimab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After cycle 8, patients receive ivonescimab IV over 60 minutes on day 1 of each cycle with or without gemcitabine IV over 30-60 minutes on days 1 and 8 of each cycle per the investigator's discretion. Cycles repeat every 21 days for up to 2 years from study treatment initiation in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood and urine samples throughout the study.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 years ]

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