Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (NCT06529718) | Clinical Trial Compass
RecruitingPhase 2
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
France, United Kingdom72 participantsStarted 2025-10-09
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed a written informed consent form prior to any trial specific procedures.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From randomisation to disease progression or death, up to 4 years
✕. 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.
✕. 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: