Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

ConditionBiliary Tract Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUNICANCER

About this trial

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.

Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed a written informed consent form prior to any trial specific procedures.

Histologically-proven intrahepatic cholangiocarcinoma, perihilar / distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded).

Locally advanced (non-resectable) or metastatic disease.

Participated in the Screening phase of the SAFIR-ABC10 trial.

Disqualifiers

Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events [NCI-CTCAE v5.0]) before randomisation with the exception of alopecia.

Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment.

Contraindication to ivonescimab.

Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).

Trial design

Design model

Parallel

Treatments tested in this trial

Ivonescimab
Drug
20 mg/kg IV infusion every 3 weeks
FOLFOX regimen
Drug
oxaliplatin 85 mg/m² IV, leucovorin 200 mg/m² IV (or folinic acid 400 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46 hour continuous IV infusion, every 2 weeks

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Progression-free survival (PFS)

The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

Time frame

From randomisation to disease progression or death, up to 4 years

Secondary outcomes

Overall Survival (OS)

The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

Time frame

From randomisation to death, up to 4 years

Objective response rate

The proportion of patients achieving complete response (CR) or partial response (PR) (according to RECIST v1.1). Objective response rate will be presented as the best response achieved compared to the disease assessment performed at randomisation.

Time frame

From randomisation, up to 4 years

Disease control rate

The proportion of randomised patients achieving CR, PR, stable disease (SD) as assessed by the investigator according to RECIST v1.1

Time frame

From randomisation, up to 4 years

Duration of response

The time from first documented response (compared to baseline measurement taken at randomisation) until the date of disease progression, as assessed by the investigator according to RECIST v1.1, or death from any cause whichever occurs first.

Time frame

From response to disease progression or death, up to 5 years

Other outcomes

Quality of life questionnaire - Core 30 (QLQ-C30)

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Time frame

From baseline, every 2 cycles (every 4-6 weeks) until end of treatment, an average of 1 year

Quality of life Questionnaire - Biliary tract cancer module (QLQ-BIL21)

This EORTC cholangiocarcinoma and gallbladder cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BIL21 contains 21 items to assess symptoms. 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, and 18 items grouped into 5 scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.

Time frame

From baseline, every 2 cycles (every 4-6 weeks) until end of treatment, an average of 1 year

Incidence of Adverse Events

Safety and tolerability of the treatment will be evaluated using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5). NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

Time frame

From randomisation, up to 4 years

Locations42

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