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Compares treatment options for Biliary Tract Cancer
Official title Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
ClinicalTrials.gov ID: NCT06529718
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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).
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Avignon, France
- Besançon, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Clichy, France
- Créteil, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Avignon, France; Besançon, France; Bordeaux, France; Caen, France and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.