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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Durvalumab

    Biological/Vaccine

    Given IV

  • Gemcitabine Hydrochloride

    Drug

    Given IV

  • Ivonescimab

    Biological/Vaccine

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Pembrolizumab

    Biological/Vaccine

    Given IV

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: Arm A (gemcitabine, cisplatin, durvalumab, pembrolizumab)Active comparator 7 interventions
Group B: Arm B (gemcitabine, cisplatin, ivonescimab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
From date of randomization until the date of death from any cause, assessed up to 3 years

Secondary outcomes

1

Progression-free survival

Will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 as assessed by the investigator.

Time frame
From the date of randomization until disease progression or death from any cause, whichever comes first, assessed up to 3 years
2

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.

Time frame
Up to 3 years
3

Duration of response

Will be measured per RECIST v1.1 as assessed by the investigator.

Time frame
From the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, assessed up to 3 years
4

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.

Time frame
From 9 weeks from date of randomization up to 3 years

Other outcomes

1

Estimates of the primary OS outcome treatment effect by sex

Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided.

Time frame
Up to 3 years
2

Estimates of the primary OS outcome treatment effect by race

Estimates of treatment effect and the corresponding 95% CIs will be provided.

Time frame
Up to 3 years
3

Estimates of the primary OS outcome treatment effect by ethnicity

Estimates of treatment effect and the corresponding 95% CIs will be provided.

Time frame
Up to 3 years

Locations

This trial has no 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

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