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Biliary Tract CancerPhase 2SEVILLANCT06529718

Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

A Phase 2 study testing Ivonescimab and FOLFOX regimen in people with Biliary Tract Cancer, run by UNICANCER at 42 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Ivonescimab and FOLFOX regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
42 sitesin 2 countries
Study dates
9 Oct 2025to 30 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Progression after first line standard of care (1L-SoC) regimen (CISGEM ± immunotherapy) as assessed by the investigator.
  • Eligible for second-line treatment with FOLFOX.
Show all 23Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Presence of at least one evaluable lesion according to RECIST v1.1.
  • Age ≥18 years.
  • Adequate bone marrow function: absolute neutrophil count (ANC) ≥2 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL.
  • Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening haematology analysis.
  • Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed/suspected Gilbert syndrome, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).
  • Adequate renal function: estimated creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula, or estimated glomerular filtration rate value ≥50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and urine protein < 2+ or 24 hour urine protein quantification < 1.0 g.
  • Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated PTT ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy,or prophylactic coagulation).
  • Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥50% at baseline as determined by either echocardiogram or multigated acquisition (MUGA) scan.
  • Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests: For patients with active HBV: HBV DNA <500 IU/ml during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir). For patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible.
  • Performance of an esophagogastroduodenoscopy within 6 months of inclusion and assessment and treatment of varices of all sizes per local standard of care prior to randomisation.
  • Biliary tract obstruction has been relieved.
  • Adequate biliary drainage, with no evidence of ongoing infection.
  • Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.
  • WOCBP must have a negative serum pregnancy test performed within 3 days before randomisation and a negative urine pregnancy test on the day of first dose, prior to treatment administration.
  • Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Affiliated to a social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).

Who cannot join

  • 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).
  • Treatment with brivudine, sorivudine or their chemical analogues in the 4 weeks prior to randomisation.
  • Major surgical procedures or serious trauma within 4 weeks prior to randomisation, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterisation and port implantation) within 3 days prior to randomisation.
Show all 40Show fewer
  • History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomisation, including but not limited to:
  • Gastrointestinal bleeding.
  • Haemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).
  • Note: transient haemoptysis associated with diagnostic bronchoscopy is allowed.
  • Nasal bleeding /epistaxis (bloody nasal discharge is allowed).
  • Need for therapeutic anticoagulant therapy within 14 days prior to randomization.
  • Note: Prophylactic anticoagulation for deep vein thrombosis or pulmonary embolism or to maintain venous patency is allowed.
  • Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
  • History of major diseases before randomization, specifically:
  • Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia),
  • History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomisation,
  • History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization,
  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomisation,
  • History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomisation.
  • Imaging during the screening period shows that the patient has:
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer,
  • Radiographic evidence of intra-tumour cavitation.
  • Microsatellite instability positive disease.
  • Concurrent malignancy (other than advanced biliary tract cancer), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
  • HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus.
  • Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy.
  • Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area,
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids,
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
  • Pregnant or breast-feeding females.
  • Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.
  • Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
  • Individuals deprived of liberty or placed under protective custody or guardianship.

Trial locations and contacts

42 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Daniel Couch contact

+33 (0)1 80 50 12 96

d-couch@unicancer.fr

42 sites in 2 countries

France41 sites, 41 recruiting

  • CHU Amiens Picardie

    Amiens

    Vincent HAUTEFEUILLE, +33(0)322088854, hautefeuille.vincent@chu-amiens.fr

    Recruiting

  • Institut de cancerologie de l'Ouest - Angers

    Angers

    Victor SIMMET, +33(0)241352700, victor.simmet@ico.unicancer.mssante.fr

    Not yet recruiting

  • Institut du Cancer Avignon Provence

    Avignon

    May MABRO, +33(0)490276268, m.mabro@isc84.org

    Recruiting

  • CHU Besançon

    Besançon

    Angélique VIENOT, +33(0)370632403, A3vienot@chu-besancon.fr

    Not yet recruiting

  • CHU de Bordeaux - Hôpital Haut-Leveque

    Bordeaux

    Jean-Frédéric BLANC, +33(0)557656439, jean-frederic.blanc@chu-bordeaux.fr

    Not yet recruiting

  • Centre François Baclesse

    Caen

    Stéphane CORBINAIS, +33(0)231455002, s.corbinais@baclesse.unicancer.fr

    Not yet recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Florence OSAER, +33(0)473278080, Florence.OSAER@clermont.unicancer.fr

    Recruiting

  • CHU Estaing de Clermont Ferrand

    Clermont-Ferrand

    Marine JARY, +33(0)473750750, mjary@chu-clermontferrand.fr

    Not yet recruiting

  • APHP - Hôpital Beaujon

    Clichy

    Mohamed BOUATTOUR, +33(0)140875614, mohamed.bouattour@aphp.fr

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil

    Christophe TOURNIGAND, +33(0)149812567, christophe.tournigand@aphp.fr

    Not yet recruiting

  • CHU de Dijon

    Dijon

    Sylvain MANFREDI, +33(0)380293750, sylvain.manfredi@chu-dijon.fr

    Recruiting

  • CHU Grenoble

    Grenoble

    Gaël ROTH, 0476765168, groth@chu-grenoble.fr

    Gaël ROTH

    Not yet recruiting

  • Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard

    Grenoble

    Hélène FLESCH, +33(0)476285232, helene.flesch@ghm-grenoble.fr

    Recruiting

  • Centre Oscar Lambret

    Lille

    Flore PIGNON, +33(0)320295959, f-pignon@o-lambret.fr

    Not yet recruiting

  • Chu Lille

    Lille

    Anthony TURPIN, +33(0)320445461, anthony.turpin@chru-lille.fr

    Not yet recruiting

  • CHU Dupuytren

    Limoges

    Frédéric THUILLIER, +33(0)555087292, frederic.thuillier@chu-limoges.fr

    Recruiting

  • Centre Leon Bérard

    Lyon

    Philippe CASSIER, +33(0)426556833, philippe.cassier@lyon.unicancer.fr

    Recruiting

  • APHM - CHU La Timone

    Marseille

    Laétitia DAHAN, +33(0)491388214, laetitia.dahan@ap-hm.fr

    Recruiting

  • Hopital Saint Joseph

    Marseille

    Hervé PERRIER, +33(0)491808211, hperrier@hopital-saint-joseph.fr

    Not yet recruiting

  • Institut Paoli Calmettes

    Marseille

    Brice CHANEZ, +33(0)491223761, CHANEZB@ipc.unicancer.fr

    Not yet recruiting

  • Institut de Cancer de Montpellier

    Montpellier

    Fabienne PORTALES, +33(0)467612353, fabienne.portales@icm.unicancer.fr

    Not yet recruiting

  • CHRU de Nancy

    Nancy

    Marie MULLER, +33(0)483153354, M.MULLER7@chru-nancy.fr

    Recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes

    Yann TOUCHEFEU, +33(0)253482243, yann.touchefeu@chu-nantes.fr

    Not yet recruiting

  • Hôpital du Confluent Nantes

    Nantes

    Hélène CASTANIE, +33(0)228272189, Helene.CASTANIE@groupeconfluent.fr

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Ludovic EVESQUE, +33(0)492031352, ludovic.evesque@nice.unicancer.fr

    Not yet recruiting

  • APHP - Hôpital Saint Antoine

    Paris

    Marie LEQUOY, +33(0)149283398, marie.lequoy@aphp.fr

    Recruiting

  • Institute Mutualiste Montsouris

    Paris

    David MALKA, MD

    David MALKA, MD

    Not yet recruiting

  • CH de Pau

    Pau

    Juliette THAURY, +33(0)559724983, juliette.thaury@ch-pau.fr

    Recruiting

  • CHU Poitiers

    Poitiers

    David TOUGERON, +33(0)549444886, david.tougeron@chu-poitiers.fr

    Not yet recruiting

  • CH Cornouaille

    Quimper

    Karine BIDEAU, +33(0)298526357, k.bideau@ch-cornouaille.fr

    Not yet recruiting

  • CHU de Reims

    Reims

    Elia GIGANTE, +33(0)326788832, egigante@chu-reims.fr

    Recruiting

  • Institut Jean Godinot

    Reims

    Damien BOTSEN, +33(0)326504246, damien.botsen@reims.unicancer.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Julien Edeline

    Julien Edeline, MD

    Recruiting

  • CHU Charles Nicolle

    Rouen

    Frederic DI FIORE, +33(0)232886456, frederic.difiore@chu-rouen.fr

    Not yet recruiting

  • Institut Curie - Saint Cloud

    Saint-Cloud

    Cindy NEUZILLET, +33(0)147117129, cindy.neuzillet@curie.fr

    Not yet recruiting

  • Institut de cancerologie de l'Ouest - St Herblain

    Saint-Herblain

    Amélie MALLET, +33(0)240679900, amelie.mallet@ico.unicancer.fr

    Not yet recruiting

  • Hôpital Foch

    Suresnes

    Asmahane BENMAZIANE, +33(0)146253619, a.benmaziane@hopital-foch.com

    Recruiting

  • CHU Toulouse

    Toulouse

    Nadim FARES, +33(0)561322142, fares.n@chu-toulouse.fr

    Recruiting

  • CH Valence

    Valence

    Hélène FOISY, +33(0)475757881, hfoisy@ch-valence.fr

    Not yet recruiting

  • APHP - Hôpital Paul Brousse

    Villejuif

    Olivier ROSMORDUC, +33(0)145596540, olivier.rosmorduc@aphp.fr

    Not yet recruiting

  • Gustave Roussy

    Villejuif

    HOLLEBECQUE, +33(0)142114385, Antoine.HOLLEBECQUE@gustaveroussy.fr

    Not yet recruiting

Other trials in France

United Kingdom1 site, 1 recruiting

  • University College London

    London

    John BRIDGEWATER, MD

    John BRIDGEWATER, MD

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1/VEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced/Metastatic Biliary Cancers

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.

Read the detailed description

This is a Phase 2, multicentre, randomised, two-arm, open-label trial to evaluate whether ivonescimab is superior to standard second-line chemotherapy in the treatment of patients with advanced biliary tract cancer.

The trial will be open to patients who participated in the screening phase of the SAFIR-ABC10 protocol (NCT05615818) and who experienced disease progression on or following the first-line standard of care (CISGEM regimen).

A total of 72 patients will be enrolled and randomly assigned (2:1) to receive treatment with either:

  • Experimental arm: Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 3 weeks (Q3W).
  • Control arm: Standard second-line chemotherapy - FOLFOX regimen Response to treatment will be assessed according to RECIST v1.1 by radiographic exams performed every 42 (±7) days. Patients will continue treatment until disease progression or for a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.
Being tested
Ivonescimab, FOLFOX regimen
Keywords
Biliary tract cancer, Gallbladder, Cholangiocarcinoma
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvonescimabDrug

    20 mg/kg IV infusion every 3 weeks

  • FOLFOX regimenDrug

    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

Study groups in NCT06529718
Study groupRoleWhat they receive
ExperimentalExperimentalExperimental treatment under study
Receives: Drug: Ivonescimab
ControlActive comparatorStandard of care second-line treatment for advanced biliary tract cancer
Receives: Drug: FOLFOX regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (4)

  1. Overall Survival (OS)

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

    Measured: From randomisation to death, up to 4 years

  2. 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.

    Measured: From randomisation, up to 4 years

  3. Disease control rate

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

    Measured: From randomisation, up to 4 years

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start9 Oct 2025
  3. Primary completion3 Aug 2027 (estimated)
  4. Study completion30 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529718
Sponsor's protocol ID
UC-GIG-2404 - PRODIGE 110
Other IDs
2024-515875-36-00
Acronym
SEVILLA
Status last verified
Oct 2025
First submitted
26 Jul 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab and FOLFOX regimen in people with Biliary Tract Cancer, run by UNICANCER at 42 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Couch (+33 (0)1 80 50 12 96, d-couch@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomisation to disease progression or death, up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06529718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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SEVILLA Clinical Trial NCT06529718 | AzTrials